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doi:10.1111/jog.12259
J. Obstet. Gynaecol. Res. Vol. 40, No. 3: 749–753, March 2014
Tramadol versus fentanyl during propofol-based deep sedation for uterine dilatation and curettage: A prospective study Ayca Tas, Veli Mıstanoglu, Sevtap Darcın and Melahat Kececioglu Department of Anesthesiology, Dr Faruk Sukan Maternity and Child Hospital, Konya, Turkey
Abstract Aim: Dilatation and curettage (D&C) is a common day-care procedure in obstetrics and gynecology, with patients discharged after a brief hospital stay on the same day of the surgery. Although it has a short duration, severe pain occurs during the procedure. Therefore, this surgical procedure requires an anesthetic to provide adequate analgesia, rapid onset, and rapid recovery. The main objective of the present study was to compare the analgesic effectiveness and safety of tramadol with those of fentanyl during D&C. Methods: The study comprised 100 women with American Society of Anesthesiologists classification I–II who were scheduled for a D&C procedure. Baseline anesthesia was maintained with 1 mg/kg propofol, and the patients were then randomly allocated to receive tramadol 1 mg/kg (Group T, n = 50) or fentanyl 1 μg/kg (Group F, n = 50). Hemodynamic variables, sedation, pain, the Aldrete recovery score, and side-effects were recorded. Results: SpO2 levels in Group F in the 5th min and at the end of the procedure were significantly lower than those in Group T (P = 0.024 and 0.021, respectively). Conclusion: Tramadol provides similar analgesic efficacy to fentanyl. Furthermore, tramadol may provide better respiratory stability in patients undergoing a D&C procedure. Key words: fentanyl, tramadol, uterine dilatation and curettage.
Introduction Dilatation of the cervix and curettage of the uterus (D&C) is a common day-care procedure in obstetrics and gynecology, with patients discharged after a brief hospital stay on the same day of the surgery.1,2 Although it has a short duration, severe pain occurs during the procedure. Therefore, this surgical procedure requires an anesthetic to provide adequate analgesia, rapid onset, and rapid recovery.2,3 Opioids are frequently preferred for D&C procedures.1–6 Although both tramadol and fentanyl are used as an analgesic agent during D&C procedures,
we found no comparison of their efficacy and safety in the published work. The main objective of the present study was to compare the analgesic effectiveness and safety of tramadol with those of fentanyl during a D&C.
Methods After receiving approval from the ethics committee of the Kirikkale University Medical School, the study was performed at a Maternity and Child Hospital. One hundred women with abnormal uterine bleeding and American Society of Anesthesiologists (ASA)
Received: January 24 2013. Accepted: August 3 2013. Reprint request to: Dr Ayca Tas, Department of Anesthesiology, Dr Faruk Sukan Maternity and Child Hospital, Nalcacı, Konya 42000, Turkey. Email: [email protected]
© 2013 The Authors Journal of Obstetrics and Gynaecology Research © 2013 Japan Society of Obstetrics and Gynecology
749
A. Tas et al.
classification I–II who were scheduled for a D&C procedure were enrolled in this prospective, double-blind, randomized study. Written informed consent was obtained from all the patients before the procedure. Exclusion criteria were as follows: patients who did not give consent, ASA III and above, age under 18 years, body mass index over 30 kg/m2, and previous hypersensitivity to any of the study drugs. All the patients fasted for at least 6 h, and no sedative premedication was administered before the procedure. The patients’ blood pressure (BP) and heart rate (HR) were monitored non-invasively via pulse oximetry and electrocardiography, respectively. An i.v. cannula was inserted, and 10 mL/kg/h 0.9% saline infusion was started. Patients were spontaneously breathing and supplemental 3 L/min of oxygen was given via a facemask throughout the procedure. According to a computer-generated list, the patients were randomly divided into two groups, Group T and Group F, with 50 patients in each group. All the patients received 1 mg/kg propofol i.v. for background anesthesia before the procedure. In addition to propofol, the Group T patients received 1 mg/kg tramadol, and the Group F patients received a 1-μg/kg fentanyl i.v. bolus before the procedure. During the procedure a speculum was inserted into the vagina and the cervix was dilated. Tissue lining the uterus was removed by using a curette. Tissue samples were sent to laboratory for histopathological evaluation. Patients’ discomfort was assessed according to body movement. Propofol 0.5 mg/kg was administered when the patient showed discomfort during the procedure. The patients’ ages, weights, and heights were noted. Measurements of BP, HR, and peripheral oxygen
saturation (SpO2) were recorded by a blinded anesthesiologist before drug administration (baseline), at the end of the induction of anesthesia (0 min), and every 5 min thereafter during the D&C. Sedation levels were evaluated using the Ramsey sedation scale (1, anxious or restless or both; 2, cooperative, orientated, and tranquil; 3, responding to commands; 4, brisk response to stimulus; 5, sluggish response to stimulus; 6, no response to stimulus), and pain scores were evaluated according to the Numerical Rating Pain Scale (0, no pain; 4–6, moderate pain; 10, worst pain). Sedation and pain levels were recorded at the beginning, 5th min, 10th min, and end of the procedure. The Aldrete recovery score, which is a well-known post-anesthesia recovery score, was determined 5 and 10 min after the completion of the procedure. The duration of the anesthesia and the D&C, total dose of propofol, and adverse events, such as nausea and vomiting during or after the procedure, were also recorded.
Statistical analysis Data were analyzed using spss 15.0 for Windows. Data are expressed as mean ± standard deviation (SD) or n, where appropriate. The Student’s t-test was employed in the analysis of the parametric continuous variables. Categorical data were analyzed using Fisher’s exact test or the χ2-test. A P-value of less than 0.05 was accepted as statistically significant.
Results The two groups were similar with respect to their demographic data (Table 1).
Table 1 Demographic and clinical data for each group
Age (years) Weight (kg) Height (cm) ASA (I/II) (n) Duration of anesthesia (min) Duration of procedure (min) Amount of additional propofol (mg) Need for additional propofol (n) Total amount of propofol (mg)
Group T (n = 50)
Group F (n = 50)
P-value
39.9 ± 9.3 71.8 ± 11.6 161.1 ± 5.9 27/23 8.5 ± 1.7 5.3 ± 1.6 47.9 ± 25.5 32 102.9 ± 29.9
36.4 ± 10.7 68.4 ± 11.7 159.1 ± 6.4 29/21 8.3 ± 2.6 5.7 ± 2.6 39.0 ± 26.7 30 91.8 ± 29.0
0.08 0.15 0.11 — 0.72 0.43 0.18 — 0.06
Data are mean ± standard deviation or n. ASA, American Society of Anesthesiologists.
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© 2013 The Authors Journal of Obstetrics and Gynaecology Research © 2013 Japan Society of Obstetrics and Gynecology
Tramadol and fentanyl during D&C
Table 2 Hemodynamic parameters for each group Variables HR (b.p.m.) Baseline 0-min 5-min 10-min End of procedure SAP (mmHg) Baseline 0-min 5-min 10-min End of procedure DAP (mmHg) Baseline 0-min 5-min 10-min End of procedure SpO2 Baseline 0-min 5-min 10-min End of procedure
Group T
Group F
P-value
91.7 ± 13.96 85.4 ± 14.10 80.6 ± 11.77 79.2 ± 16.25 80.0 ± 11.76
93.2 ± 16.71 85.9 ± 15.72 79.0 ± 12.05 76.2 ± 9.96 78.4 ± 9.88
0.62 0.87 0.53 0.86 0.48
132.4 ± 14.94 128.4 ± 16.85 128.6 ± 18.17 112.2 ± 17.87 128.6 ± 19.07
138.4 ± 21.32 123.8 ± 22.42 121.7 ± 14.87 129.6 ± 22.97 122.1 ± 16.17
0.11 0.25 0.05 0.30 0.07
75.5 ± 11.66 72.5 ± 12.64 73.5 ± 13.19 66.5 ± 17.93 73.4 ± 12.83
78.0 ± 14.86 69.9 ± 14.16 70.3 ± 13.01 74.0 ± 13.15 70.4 ± 11.28
0.35 0.33 0.26 0.44 0.22
98.0 ± 1.49 98.5 ± 1.19 98.7 ± 0.96 98.7 ± 0.50 98.6 ± 1.09
98.2 ± 1.29 98.2 ± 1.91 98.0 ± 1.78* 98.3 ± 1.59 98.0 ± 1.72*
0.43 0.35 0.02 0.92 0.02
*P < 0.05 versus Group T. Bold P-values are significant. Data are mean ± standard deviation. DAP, diastolic arterial pressure; HR, heart rate; SAP, systolic arterial pressure; SpO2, arterial oxygen saturation.
The duration of both the anesthesia and the procedure and the amount of propofol used during the procedure were also comparable between the groups (Table 1). The hemodynamic parameters, such as HR and systolic and diastolic arterial BP, were comparable between the groups. However, the SpO2 levels of Group F in the 5th min and at the end of the procedure were significantly lower than that of Group T (P = 0.024 and 0.021, respectively) (Table 2). The pain assessment and sedation scores did not differ significantly between the groups (Table 3). Five minutes after the procedure, in Group T, all 50 patients had an Aldrete recovery score of 10, and in Group F this occurred in 49 of the 50 patients. Ten minutes after the procedure all patients had an Aldrete recovery score of 10 (Table 3). In terms of the side-effects, only one patient in Group F suffered from nausea and vomiting, which was treated with antiemetic agents (Table 3).
Discussion We demonstrated that the effects of both tramadol/ propofol and fentanyl/propofol combinations on BP,
HR, sedation score, recovery score, pain score, and side-effects (such as nausea and vomiting) were similar. However, according to the SpO2 levels, tramadol provided superior safety with better respiratory stability. Propofol, 2,6-diisopropylphenol is one of the most popular intravenous sedative-hypnotic agents used during D&C procedures because of its pharmacokinetic and pharmacodynamic properties. These result in rapid onset and offset of the drug’s effects and relatively benign side-effects.7–9 Recovery from propofol should occur within minutes and is generally marked by a sense of well-being.7 Although propofol seems a nearly ideal sedative agent for D&C procedures, its poor analgesic properties necessitate additional analgesic medication. In many studies, various types of analgesic agents, such as fentanyl, alfentanil, remifentanil, nalbuphine, tramadol, and ketamine, have been combined with propofol during D&C procedures.1–6 Tramadol is a synthetic, centrally acting analgesic agent with two distinct, synergistic mechanisms of action, acting both as a weak opioid agonist with selectivity for the μ-receptor and as an inhibitor of monoamine neurotransmitter reuptake of noradrenaline and
© 2013 The Authors Journal of Obstetrics and Gynaecology Research © 2013 Japan Society of Obstetrics and Gynecology
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A. Tas et al.
Table 3 Sedation scores, numerical rating scale, Aldrete scores Variables Numerical rating scale Operation 0-min Operation 5-min Operation 10-min End of operation Sedation scores 0-min 5-min 10-min End of procedure Aldrete scores Aldrete score of 10 at 5 min (n) Aldrete score of 10 at 10 min (n) Nausea/vomiting (n)
Group T
Group F
P-value
1.0 ± 1.48 0.8 ± 1.18 1.2 ± 0.50 0.5 ± 0.67
0.4 ± 0.70 0.5 ± 1.08 0.5 ± 0.75 0.3 ± 0.62
NS NS NS NS
2.84 ± 1.25 3.14 ± 0.97 2.75 ± 0.95 3.26 ± 1.20
2.64 ± 1.38 2.97 ± 1.26 2.22 ± 1.09 2.76 ± 1.25
NS NS NS NS
50 50 1
49 50 0
NS NS NS
Data are mean ± standard deviation or n. NS, not significant.
serotonin. It also displaces serotonin stores within the spinal cord, facilitating descending pain inhibitory pathways.10,11 The side-effects of tramadol have been reported to be less sedation, lack of remarkable respiratory depression, and minimal gastrointestinal dysfunction, all of which are favorable for ambulatory surgery.12 Fentanyl, a synthetic, lipophilic opioid, is 80–100 times as potent as morphine. It is another analgesic drug used in combination with propofol during daycare surgery.1,5,13 A 1–2-μg/kg dose of fentanyl i.v. exerts a peak effect within 5 min and provides effective analgesia for roughly 30 min.7 The side-effects of fentanyl are dose-related.7 By rapidly crossing the blood– brain barrier, fentanyl produces analgesia. Sedation may cause adverse effects, such as respiratory depression, nausea, and vomiting.7 Opioid analgesics are generally associated with respiratory depression. This is mediated through a decrease in the sensitivity of the respiratory centre to CO2, resulting in a decrease in respiratory rate and tidal volume.10 The effects of opioids on respiration are multifaceted. They affect the tidal volume and respiratory rate, mainly through prolongation of expiratory time and responses to other stimuli.14 Fentanyl causes doserelated respiratory depression, which is also more pronounced when administered in combination with sedatives.7 On the other hand, evidence from studies in healthy volunteers and surgical patients has shown that tramadol, unlike other opioids, is unlikely to produce clinically relevant respiratory depression at the recommended dosage.10 Similarly, in the present study, we found that the decrease in SpO2 levels in the patients who received fentanyl was significant.
752
In conclusion, the results of the present study suggest that tramadol provides similar analgesic efficacy to fentanyl. Furthermore, tramadol may provide better respiratory stability in patients undergoing a D&C procedure when combined with propofol.
Disclosure No author has a financial or proprietary interest in any material or method mentioned.
References 1. Kücük M, Ug˘ur B, Og˘urlu M. Comparing the administration of fentanyl 1 μg kg−1 and fentanyl 0.5 μg kg−1 in dilatation and curettage procedures. Gynecol Endocrinol 2012; 28: 736–739. 2. Siddiqui KM, Chohan U. Tramadol versus nalbuphine in total intravenous anaesthesia for dilatation and evacuation. J Pak Med Assoc 2007; 57: 67–70. 3. Castillo T, Avellanal M, Garcia de Lucas E. Bolus application of remifentanil with propofol for dilatation and curettage. Eur J Anaesthesiol 2004; 21: 408–411. 4. Seitsonen ER, Cohen-Larogue ES, van Gils MJ, Korttila KT, Neuvonen PJ, Yli-Hankala A. Propofol versus alfentanil to prevent movement responses during uterine curettage. Acta Anaesthesiol Scand 2007; 51: 751–758. 5. Og˘urlu M, Küçük M, Bilgin F et al. Comparison of bolus remifentanil-propofol versus bolus fentanyl-propofol for dilatation and sharp curettage. Clin Exp Obstet Gynecol 2010; 37: 209–212. 6. Sahin L, Sahin M, Aktas O, Kilic E, Mandollu E. Comparison of propofol/ketamine versus propofol/alfentanil for dilatation and curettage. Clin Exp Obstet Gynecol 2012; 39: 72–75. 7. Toledano RD, Kodali BS, Camann WR. Anesthesia drugs in the obstetric and gynecologic practice. Rev Obstet Gynecol 2009; 2: 93–100. 8. Uerpairojkit K, Urusopone P, Somboonviboon W. A randomised controlled study of three targets of propofol
© 2013 The Authors Journal of Obstetrics and Gynaecology Research © 2013 Japan Society of Obstetrics and Gynecology
Tramadol and fentanyl during D&C
plasma concentration in patients undergoing uterine dilatation and curettage. J Obstet Gynaecol Res 2003; 29: 79–83. 9. Vanlersberghe C, Camu F. Propofol. Handb Exp Pharmacol 2008; 182: 227–252. 10. Scott LJ, Perry CM. Tramadol: A review of its use in perioperative pain. Drugs 2000; 60: 139–176. 11. Putland AJ, McCluskey A. The analgesic efficacy of tramadol versus ketorolac in day-case laparoscopic sterilisation. Anaesthesia 1999; 54: 372–392.
12. Vickers MD, O’Flaherty D, Szekely SM, Read M, Yoshizumi J. Tramadol: Pain relief by an opioid without depression of respiration. Anaesthesia 1992; 47: 291–296. 13. Horn E, Nesbit SA. Pharmacology and pharmacokinetics of sedatives and analgesics. Gastrointest Endosc Clin N Am 2001; 14: 247–268. 14. Yamanaka T, Sadikot RT. Opioid effect on lung. Respirology 2013; 18: 255–262.
© 2013 The Authors Journal of Obstetrics and Gynaecology Research © 2013 Japan Society of Obstetrics and Gynecology
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doi:10.1111/jog.12259
J. Obstet. Gynaecol. Res. Vol. 40, No. 3: 749–753, March 2014
Tramadol versus fentanyl during propofol-based deep sedation for uterine dilatation and curettage: A prospective study Ayca Tas, Veli Mıstanoglu, Sevtap Darcın and Melahat Kececioglu Department of Anesthesiology, Dr Faruk Sukan Maternity and Child Hospital, Konya, Turkey
Abstract Aim: Dilatation and curettage (D&C) is a common day-care procedure in obstetrics and gynecology, with patients discharged after a brief hospital stay on the same day of the surgery. Although it has a short duration, severe pain occurs during the procedure. Therefore, this surgical procedure requires an anesthetic to provide adequate analgesia, rapid onset, and rapid recovery. The main objective of the present study was to compare the analgesic effectiveness and safety of tramadol with those of fentanyl during D&C. Methods: The study comprised 100 women with American Society of Anesthesiologists classification I–II who were scheduled for a D&C procedure. Baseline anesthesia was maintained with 1 mg/kg propofol, and the patients were then randomly allocated to receive tramadol 1 mg/kg (Group T, n = 50) or fentanyl 1 μg/kg (Group F, n = 50). Hemodynamic variables, sedation, pain, the Aldrete recovery score, and side-effects were recorded. Results: SpO2 levels in Group F in the 5th min and at the end of the procedure were significantly lower than those in Group T (P = 0.024 and 0.021, respectively). Conclusion: Tramadol provides similar analgesic efficacy to fentanyl. Furthermore, tramadol may provide better respiratory stability in patients undergoing a D&C procedure. Key words: fentanyl, tramadol, uterine dilatation and curettage.
Introduction Dilatation of the cervix and curettage of the uterus (D&C) is a common day-care procedure in obstetrics and gynecology, with patients discharged after a brief hospital stay on the same day of the surgery.1,2 Although it has a short duration, severe pain occurs during the procedure. Therefore, this surgical procedure requires an anesthetic to provide adequate analgesia, rapid onset, and rapid recovery.2,3 Opioids are frequently preferred for D&C procedures.1–6 Although both tramadol and fentanyl are used as an analgesic agent during D&C procedures,
we found no comparison of their efficacy and safety in the published work. The main objective of the present study was to compare the analgesic effectiveness and safety of tramadol with those of fentanyl during a D&C.
Methods After receiving approval from the ethics committee of the Kirikkale University Medical School, the study was performed at a Maternity and Child Hospital. One hundred women with abnormal uterine bleeding and American Society of Anesthesiologists (ASA)
Received: January 24 2013. Accepted: August 3 2013. Reprint request to: Dr Ayca Tas, Department of Anesthesiology, Dr Faruk Sukan Maternity and Child Hospital, Nalcacı, Konya 42000, Turkey. Email: [email protected]
© 2013 The Authors Journal of Obstetrics and Gynaecology Research © 2013 Japan Society of Obstetrics and Gynecology
749
A. Tas et al.
classification I–II who were scheduled for a D&C procedure were enrolled in this prospective, double-blind, randomized study. Written informed consent was obtained from all the patients before the procedure. Exclusion criteria were as follows: patients who did not give consent, ASA III and above, age under 18 years, body mass index over 30 kg/m2, and previous hypersensitivity to any of the study drugs. All the patients fasted for at least 6 h, and no sedative premedication was administered before the procedure. The patients’ blood pressure (BP) and heart rate (HR) were monitored non-invasively via pulse oximetry and electrocardiography, respectively. An i.v. cannula was inserted, and 10 mL/kg/h 0.9% saline infusion was started. Patients were spontaneously breathing and supplemental 3 L/min of oxygen was given via a facemask throughout the procedure. According to a computer-generated list, the patients were randomly divided into two groups, Group T and Group F, with 50 patients in each group. All the patients received 1 mg/kg propofol i.v. for background anesthesia before the procedure. In addition to propofol, the Group T patients received 1 mg/kg tramadol, and the Group F patients received a 1-μg/kg fentanyl i.v. bolus before the procedure. During the procedure a speculum was inserted into the vagina and the cervix was dilated. Tissue lining the uterus was removed by using a curette. Tissue samples were sent to laboratory for histopathological evaluation. Patients’ discomfort was assessed according to body movement. Propofol 0.5 mg/kg was administered when the patient showed discomfort during the procedure. The patients’ ages, weights, and heights were noted. Measurements of BP, HR, and peripheral oxygen
saturation (SpO2) were recorded by a blinded anesthesiologist before drug administration (baseline), at the end of the induction of anesthesia (0 min), and every 5 min thereafter during the D&C. Sedation levels were evaluated using the Ramsey sedation scale (1, anxious or restless or both; 2, cooperative, orientated, and tranquil; 3, responding to commands; 4, brisk response to stimulus; 5, sluggish response to stimulus; 6, no response to stimulus), and pain scores were evaluated according to the Numerical Rating Pain Scale (0, no pain; 4–6, moderate pain; 10, worst pain). Sedation and pain levels were recorded at the beginning, 5th min, 10th min, and end of the procedure. The Aldrete recovery score, which is a well-known post-anesthesia recovery score, was determined 5 and 10 min after the completion of the procedure. The duration of the anesthesia and the D&C, total dose of propofol, and adverse events, such as nausea and vomiting during or after the procedure, were also recorded.
Statistical analysis Data were analyzed using spss 15.0 for Windows. Data are expressed as mean ± standard deviation (SD) or n, where appropriate. The Student’s t-test was employed in the analysis of the parametric continuous variables. Categorical data were analyzed using Fisher’s exact test or the χ2-test. A P-value of less than 0.05 was accepted as statistically significant.
Results The two groups were similar with respect to their demographic data (Table 1).
Table 1 Demographic and clinical data for each group
Age (years) Weight (kg) Height (cm) ASA (I/II) (n) Duration of anesthesia (min) Duration of procedure (min) Amount of additional propofol (mg) Need for additional propofol (n) Total amount of propofol (mg)
Group T (n = 50)
Group F (n = 50)
P-value
39.9 ± 9.3 71.8 ± 11.6 161.1 ± 5.9 27/23 8.5 ± 1.7 5.3 ± 1.6 47.9 ± 25.5 32 102.9 ± 29.9
36.4 ± 10.7 68.4 ± 11.7 159.1 ± 6.4 29/21 8.3 ± 2.6 5.7 ± 2.6 39.0 ± 26.7 30 91.8 ± 29.0
0.08 0.15 0.11 — 0.72 0.43 0.18 — 0.06
Data are mean ± standard deviation or n. ASA, American Society of Anesthesiologists.
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© 2013 The Authors Journal of Obstetrics and Gynaecology Research © 2013 Japan Society of Obstetrics and Gynecology
Tramadol and fentanyl during D&C
Table 2 Hemodynamic parameters for each group Variables HR (b.p.m.) Baseline 0-min 5-min 10-min End of procedure SAP (mmHg) Baseline 0-min 5-min 10-min End of procedure DAP (mmHg) Baseline 0-min 5-min 10-min End of procedure SpO2 Baseline 0-min 5-min 10-min End of procedure
Group T
Group F
P-value
91.7 ± 13.96 85.4 ± 14.10 80.6 ± 11.77 79.2 ± 16.25 80.0 ± 11.76
93.2 ± 16.71 85.9 ± 15.72 79.0 ± 12.05 76.2 ± 9.96 78.4 ± 9.88
0.62 0.87 0.53 0.86 0.48
132.4 ± 14.94 128.4 ± 16.85 128.6 ± 18.17 112.2 ± 17.87 128.6 ± 19.07
138.4 ± 21.32 123.8 ± 22.42 121.7 ± 14.87 129.6 ± 22.97 122.1 ± 16.17
0.11 0.25 0.05 0.30 0.07
75.5 ± 11.66 72.5 ± 12.64 73.5 ± 13.19 66.5 ± 17.93 73.4 ± 12.83
78.0 ± 14.86 69.9 ± 14.16 70.3 ± 13.01 74.0 ± 13.15 70.4 ± 11.28
0.35 0.33 0.26 0.44 0.22
98.0 ± 1.49 98.5 ± 1.19 98.7 ± 0.96 98.7 ± 0.50 98.6 ± 1.09
98.2 ± 1.29 98.2 ± 1.91 98.0 ± 1.78* 98.3 ± 1.59 98.0 ± 1.72*
0.43 0.35 0.02 0.92 0.02
*P < 0.05 versus Group T. Bold P-values are significant. Data are mean ± standard deviation. DAP, diastolic arterial pressure; HR, heart rate; SAP, systolic arterial pressure; SpO2, arterial oxygen saturation.
The duration of both the anesthesia and the procedure and the amount of propofol used during the procedure were also comparable between the groups (Table 1). The hemodynamic parameters, such as HR and systolic and diastolic arterial BP, were comparable between the groups. However, the SpO2 levels of Group F in the 5th min and at the end of the procedure were significantly lower than that of Group T (P = 0.024 and 0.021, respectively) (Table 2). The pain assessment and sedation scores did not differ significantly between the groups (Table 3). Five minutes after the procedure, in Group T, all 50 patients had an Aldrete recovery score of 10, and in Group F this occurred in 49 of the 50 patients. Ten minutes after the procedure all patients had an Aldrete recovery score of 10 (Table 3). In terms of the side-effects, only one patient in Group F suffered from nausea and vomiting, which was treated with antiemetic agents (Table 3).
Discussion We demonstrated that the effects of both tramadol/ propofol and fentanyl/propofol combinations on BP,
HR, sedation score, recovery score, pain score, and side-effects (such as nausea and vomiting) were similar. However, according to the SpO2 levels, tramadol provided superior safety with better respiratory stability. Propofol, 2,6-diisopropylphenol is one of the most popular intravenous sedative-hypnotic agents used during D&C procedures because of its pharmacokinetic and pharmacodynamic properties. These result in rapid onset and offset of the drug’s effects and relatively benign side-effects.7–9 Recovery from propofol should occur within minutes and is generally marked by a sense of well-being.7 Although propofol seems a nearly ideal sedative agent for D&C procedures, its poor analgesic properties necessitate additional analgesic medication. In many studies, various types of analgesic agents, such as fentanyl, alfentanil, remifentanil, nalbuphine, tramadol, and ketamine, have been combined with propofol during D&C procedures.1–6 Tramadol is a synthetic, centrally acting analgesic agent with two distinct, synergistic mechanisms of action, acting both as a weak opioid agonist with selectivity for the μ-receptor and as an inhibitor of monoamine neurotransmitter reuptake of noradrenaline and
© 2013 The Authors Journal of Obstetrics and Gynaecology Research © 2013 Japan Society of Obstetrics and Gynecology
751
A. Tas et al.
Table 3 Sedation scores, numerical rating scale, Aldrete scores Variables Numerical rating scale Operation 0-min Operation 5-min Operation 10-min End of operation Sedation scores 0-min 5-min 10-min End of procedure Aldrete scores Aldrete score of 10 at 5 min (n) Aldrete score of 10 at 10 min (n) Nausea/vomiting (n)
Group T
Group F
P-value
1.0 ± 1.48 0.8 ± 1.18 1.2 ± 0.50 0.5 ± 0.67
0.4 ± 0.70 0.5 ± 1.08 0.5 ± 0.75 0.3 ± 0.62
NS NS NS NS
2.84 ± 1.25 3.14 ± 0.97 2.75 ± 0.95 3.26 ± 1.20
2.64 ± 1.38 2.97 ± 1.26 2.22 ± 1.09 2.76 ± 1.25
NS NS NS NS
50 50 1
49 50 0
NS NS NS
Data are mean ± standard deviation or n. NS, not significant.
serotonin. It also displaces serotonin stores within the spinal cord, facilitating descending pain inhibitory pathways.10,11 The side-effects of tramadol have been reported to be less sedation, lack of remarkable respiratory depression, and minimal gastrointestinal dysfunction, all of which are favorable for ambulatory surgery.12 Fentanyl, a synthetic, lipophilic opioid, is 80–100 times as potent as morphine. It is another analgesic drug used in combination with propofol during daycare surgery.1,5,13 A 1–2-μg/kg dose of fentanyl i.v. exerts a peak effect within 5 min and provides effective analgesia for roughly 30 min.7 The side-effects of fentanyl are dose-related.7 By rapidly crossing the blood– brain barrier, fentanyl produces analgesia. Sedation may cause adverse effects, such as respiratory depression, nausea, and vomiting.7 Opioid analgesics are generally associated with respiratory depression. This is mediated through a decrease in the sensitivity of the respiratory centre to CO2, resulting in a decrease in respiratory rate and tidal volume.10 The effects of opioids on respiration are multifaceted. They affect the tidal volume and respiratory rate, mainly through prolongation of expiratory time and responses to other stimuli.14 Fentanyl causes doserelated respiratory depression, which is also more pronounced when administered in combination with sedatives.7 On the other hand, evidence from studies in healthy volunteers and surgical patients has shown that tramadol, unlike other opioids, is unlikely to produce clinically relevant respiratory depression at the recommended dosage.10 Similarly, in the present study, we found that the decrease in SpO2 levels in the patients who received fentanyl was significant.
752
In conclusion, the results of the present study suggest that tramadol provides similar analgesic efficacy to fentanyl. Furthermore, tramadol may provide better respiratory stability in patients undergoing a D&C procedure when combined with propofol.
Disclosure No author has a financial or proprietary interest in any material or method mentioned.
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