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doi: 10.1111/den.12219

Review

Propofol versus traditional sedative agents for advanced endoscopic procedures: A meta-analysis Saurabh Sethi,1 Vaibhav Wadhwa,3 Adarsh Thaker,2 Ram Chuttani,1 Douglas K. Pleskow,1 Sheila R. Barnett,1 Daniel A. Leffler,1 Tyler M. Berzin,1 Nidhi Sethi1 and Mandeep S. Sawhney1 1

Division of Gastroenterology, 2Department of Internal Medicine, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, USA, and 3Department of Internal Medicine, Pushpanjali Crosslay Hospital, New Delhi, India Background and Aim: The optimum method for sedation for advanced endoscopic procedures is not known. Propofol deep sedation has a faster recovery time than traditional sedative agents, but may be associated with increased complication rates. The aim of the present study was to pool data from all available studies to systematically compare the efficacy and safety of propofol with traditional sedative agents for advanced endoscopic procedures. Methods: Databases including PubMed, Embase, Web of Science and the Cochrane Central Register of Controlled Trials updated as of January 2013 were searched. Main outcome measures were procedure duration, recovery time, incidence of complications (hypotension, hypoxia), sedation level, patient cooperation and amnesia during advanced endoscopic procedures such as endoscopic retrograde cholangiopancreatography, endoscopic ultrasonography, and deep small bowel enteroscopy. Results: Nine prospective randomized trials with a total of 969

the meta-analysis. Pooled mean difference in procedure duration between propofol and traditional sedative agents was −2.3 min [95% CI: −6.36 to 1.76, P = 0.27], showing no significant difference in procedure duration between the two groups. Pooled mean difference in recovery time was −30.26 min [95% CI: −46.72 to −13.80, P < 0.01], showing significantly decreased recovery time with propofol. There was also no significant difference between the two groups with regard to hypoxia and hypotension.

Conclusions: Propofol for advanced endoscopic procedures is associated with shorter recovery time, better sedation and amnesia level without an increased risk of cardiopulmonary complications. Overall patient cooperation was also improved with propofol sedation. Key words: advanced endoscopic procedure, meta-analysis, outcome, propofol, traditional sedative agent

patients (485 propofol, 484 conscious sedation) were included in

INTRODUCTION

P

ROPOFOL (2,6-DIISOPROPYLPHENOL) IS A shortacting i.v. anesthetic agent (t1/2 = 2–4 min) that provides clinically significant levels of sedation and amnesia.1 Induction time of propofol deep sedation (PDS) depends on several patient factors but can be as short as 15–30 s. Similarly, recovery times after PDS are also rapid (10–20 min), often less than with typical narcotic and benzodiazepine regimens for traditional sedative agents.2–4 For these reasons, propofol continues to cultivate its attractiveness among gastrointestinal endoscopists.5,6

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Corresponding: Saurabh Sethi, Division of Gastroenterology, Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Boston, MA 02115, USA. Email: [email protected] Received 22 July 2013; accepted 11 November 2013.

The general excitement regarding PDS has given rise to a paradigm shift in gastrointestinal endoscopy. In some cases, patients even ask for it by name. However, as with any innovative application, including medications, most endoscopists prefer to wait until investigations can demonstrate adequate safety data before changing their practice. At present, the literature is still expanding regarding PDS safety during gastrointestinal endoscopy. Therefore, numerous studies using PDS are now underway to study its use and experience at centers of excellence. PDS has been studied during basic gastrointestinal endoscopy. In fact, use of PDS during routine upper gastrointestinal endoscopy and colonoscopy has largely shifted from safety7–11 to costeffectiveness studies.12,13 There are limited data, however, regarding the use of PDS for more complex, advanced endoscopic procedures such as endoscopic retrograde cholangiopancreatography (ERCP), endoscopic ultrasonography (EUS) and deep small bowel

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enteroscopy.9,14,15 Propofol may actually be well suited for use in this group of patients as a result of the length and complexity of these procedures compared with routine upper endoscopy and colonoscopy. Propofol typically provides much deeper levels of sedation than meperidine/midazolam or fetanyl/midazolam etc. given for moderate sedation, giving improved patient comfort during the procedure. In addition, because of its rapid onset of action and predictable dose effect, it can provide a consistent level of sedation during longer endoscopic procedures. Despite these advantages, propofol use has been hampered by its ‘black box’ warning, which states that only personnel trained in giving general anesthesia should use this agent by virtue of its narrow therapeutic window, which has led to the perception of increased complication risks. The concern is that because propofol is a deep sedative agent without any antidotes, it might cause more cardiovascular complications than traditional agents.16,17 However, there is limited evidence to suggest that this is indeed true. Traditional moderate sedation uses benzodiazepines alone or in combination with an opiate analgesic. In general, this regimen is well tolerated. Its safety profile is reflected in its general acceptance as the standard regimen for sedation in general gastrointestinal endoscopy. Furthermore, this regimen is often used as the standard for comparison against novel sedative combinations or compounds being evaluated for use during endoscopy.4,5,7,9,18–25 However, few comparisons exist for advanced endoscopic procedures.26,27 A number of studies comparing outcomes of PDS with those of moderate sedation during advanced endoscopic procedures have been done. However, the results of individual studies comparing these two sedation techniques have not been able to identify a dominant strategy. A recent metaanalysis on the topic looked at propofol use in all gastrointestinal endoscopic procedures.28 As there is much difference in complexity, techniques and procedure duration between routine and advanced endoscopic procedures, the results might be biased. Hence, we proposed that pooling all available studies for advanced endoscopic procedures together systematically may provide a better understanding of the performance of these two sedation techniques. The objective of our study was to perform a meta-analysis to assess the efficacy and safety of propofol versus traditional sedative agents for advanced endoscopic procedures.

METHODS Searching strategy

A

SYSTEMATIC LITERATURE SEARCH of MEDLINE (1966 through 15 June, 2013), Embase (1988 through 15 June, 2013), Web of Science (1993 through

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15 June, 2013) databases and the Cochrane Central Register of Controlled Trials updated to June 2013 was conducted. All bibliographies were identified in the reference lists to identify eligible studies. Key words including propofol, traditional sedative agents, endoscopic retrograde cholangiopancreatography, endoscopic ultrasonography, deep small bowel enteroscopy, single balloon enteroscopy, double balloon enteroscopy, spirus enteroscopy, meta-analysis and outcomes were used to identify the relevant articles. Internet search engines, Google Scholar and Yahoo, were also searched with relevant key words. We also manually searched the abstracts from major Gastroenterology conferences (i.e. Digestive Disease Week and American College of Gastroenterology [2003–2012]). Two investigators (SS and MSS) independently reviewed titles and abstracts of all citations identified by the literature search. When incomplete information was available, attempts were made to contact the corresponding authors of the studies for additional information. Potentially relevant studies were retrieved and selection criteria applied.

Inclusion and exclusion criteria Only randomized controlled trials (RCT) in adult patients aged >18 years who underwent advanced endoscopic procedures, published as full articles or meeting abstracts in peerreviewed journals, were considered. Selection criteria were: (i) studies that examined the efficacy and safety of propofol sedation and traditional sedative agents in advanced endoscopic procedures (i.e ERCP, EUS, deep small bowel enteroscopy); (ii) studies that were prospective and randomized; (iii) studies in humans; and (iv) data not duplicated in another manuscript. Inclusion was not otherwise restricted by study size or language. To understand the risk of bias in individual studies, a formal quality assessment of studies was carried out. The methodological quality of the RCT was assessed by two authors independently (SS and MSS) using the scale validated by Jadad et al.29 and scored from 0 to 5: randomization (0–2 points), blinding (0–2 points), and full accounting of all patients (0–1 point); a higher score indicating better quality.

Data abstraction Data were independently abstracted onto a standardized form by two reviewers (SS and MSS). The following data were collected from each study: study design, year of publication, country of the population studied, primary outcome reported, type of sedation, total number of persons in each group (propofol vs traditional sedative agents), single-center or multi-center trial. Agreement between investigators was excellent (kappa= 0.95).

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Outcomes assessed

Characteristics of the selected studies

Outcome measures were procedure duration, recovery time, sedation level, patient cooperation during procedure, incidence of hypotension and hypoxia during procedure and amnesia of the procedure.

Characteristics of the nine included studies are summarized in Table 1. Quality assessment revealed that all nine trials had a Jadad score of ≥3, which suggested a good study design or high quality of report. Baseline characteristics of patients included in the nine trials are listed in Table 2.

Statistical analysis Statistical analysis was performed using Review Manager (RevMan version 5.1; The Nordic Cochrane Centre, The Cochrane Collaboration, Copenhagen, Denmark), the Cochrane Collaboration’s software for preparing and maintaining Cochrane systematic reviews. Meta-analysis was done using fixed effect or random-effect methods, depending on the absence or presence of significant heterogeneity. We used the χ2-test and I2 inconsistency statistic to assess heterogeneity between trials. P < 0.1 or I2 > 50% was defined as significant heterogeneity. Results were expressed as odd’s ratio (OR) or mean difference with 95% CI. P < 0.05 was considered statistically significant. Potential publication bias was examined by funnel plot.

Out of nine studies, seven measured procedure time during propofol sedation and traditional sedative agents for advanced endoscopic procedures. Five of those studies evaluated ERCP, one evaluated EUS only and one evaluated both ERCP and EUS. The pooled mean difference in procedure duration between propofol and traditional sedative agents was −2.30 min [95% CI: −6.36 to 1.76, P = 0.27], showing no significant difference in procedure duration between the two groups. The χ2 and I2 were 16.61 (P = 0.01) and 64%, respectively, which indicated significant heterogeneity among the studies with respect to procedure duration (Fig. 2).

RESULTS

Recovery time

Selected RCT

Six studies reported recovery time after propofol sedation and traditional sedative agents for advanced endoscopic procedures. Five of these evaluated ERCP and one evaluated both ERCP and EUS. Those included 640 patients undergoing ERCP and 18 undergoing EUS. Our meta-analysis revealed that the pooled mean difference in the recovery time was −30.26 min [95% CI: −46.72 to −13.80, P < 0.01], showing decreased recovery time with propofol. The χ2 and I2 were 589.17 (P < 0.01) and 99%, respectively, which indicated significant heterogeneity among the studies with respect to recovery time (Fig. 3).

F

IGURE 1 SHOWS THE process of study selection. Of the 213 unique studies identified using our search criteria, nine studies fulfilled our inclusion criteria and were included in the meta-analysis. These were RCT, with a total of 969 patients (485 propofol, 484 conscious sedation [CS]). Among these, four trials were reported from Germany,14,30–32 two from USA9,33 and one trial each from Israel,34 China35 and Thailand.36 All eligible articles were reported in the form of full-text articles.

Procedure duration

Sedation level Three studies measured sedation level during propofol sedation and traditional sedative agents for advanced endoscopic procedures. All three of them evaluated this during ERCP. Adequate level of sedation was defined as the absence of resistance to the procedure. Our meta-analysis revealed that propofol provided significantly better sedation than traditional sedative agents, OR = 11.10 [95% CI: 3.26 to 37.83, P < 0.01], showing increased sedation level with propofol. The χ2 and I2 were 1.24 (P = 0.54) and 0%, respectively, which indicated significant heterogeneity was not present among the studies with respect to sedation level (Fig. 4).

Patient cooperation during procedure Figure 1 Flow diagram of included and excluded trials.

Four studies evaluated patient cooperation during procedures with propofol sedation and traditional sedative agents

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ERCP/EUS/ DBE Germany Schilling et al.32

Registered Nurse

ERCP Gastroenterologist Thailand Kongkam et al.36

EUS Registered Nurse USA DeWitt et al.

ERCP Germany Riphaus et al.31

ICU physician

China Chen et al.35

33

ERCP

USA Vargo et al.9

ICU physician

ERCP/EUS

Israel Krugliak et al.34

Gastroenterologist

ERCP

ERCP

Anesthesiologist Gastroenterologist Anesthesiologist Germany Jung et al.30

DBE, double balloon enteroscopy; ERCP, endoscopic retrograde cholangiopancreatography; EUS, endoscopic ultrasonography; M/M, midazolam/meperidine; N/A, not available.

22 ± 7 31 ± 8 N/A N/A 17.2 ± 5.9 34.3 ± 16.1 N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A 29 ± 19 30 ± 19 35.0 ± 18.2 32.5 ± 21.7 39.8 ± 32.5 41.8 ± 21.8 N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A 77 78 40 40 67 67 76 75

8 7 3 6 15 21 N/A N/A

6 4 6 7 6 6 N/A N/A

N/A N/A 39 32 15 14 N/A N/A 35 23 27 ± 16 32 ± 14 N/A N/A 39.3 ± 25.7 42.2 ± 37.5 53.6 ± 4.3 51.8 ± 5.1 49.2 ± 24.6 65.6 ± 25.2 N/A N/A 39 28 15 14 N/A N/A 35 33 ERCP Germany Wehrmann et al.14

Gastroenterologist

Propofol Midazolam Propofol Midazolam Propofol Midazolam Propofol M/M Propofol Meperidine + Scopolamine Propofol M/M Propofol M/M Propofol M/M Propofol M/M

100 100 40 40 15 17 38 37 35 35

11 8 N/A N/A 0 0 14 21 2 3

7 2 1 0 0 0 6 7 7 0

Sedation level Procedure time (min) Amnesia Hypotension Hypoxia No. patients Procedure Sedation Administrator Country Study

Table 1 Characteristics of studies included in the meta-analysis

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19 ± 8 29 ± 8 N/A N/A 13.1 ± 5.8 58.4 ± 29.4 18.6 ± 6.5 70.5 ± 7.1 5.2 ± 1.9 63.9 ± 78.0

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for advanced endoscopic procedures. Patient cooperation was assessed and evaluated by patient’s response to the visual analog scale. Our meta-analysis revealed that the pooled mean difference in the patient cooperation was 1.27 [95% CI: 0.35 to 2.19, P = 0.007], showing more patient cooperation during procedures with propofol sedation as compared to traditional sedative agents. The χ2 and I2 were 82.07 (P < 0.01) and 96%, respectively, which indicated significant heterogeneity among the studies with respect to patient cooperation during procedure (Fig. 5).

Amnesia Amnesia about the procedure was reported in three studies. Our meta-analysis revealed that there was significantly more amnesia in the propofol group as compared to traditional sedative agents, with a pooled mean difference of 5.98 [95 % CI: 1.26 to 28.40, P = 0.02]. The χ2 and I2 were 0.03 (P = 0.98) and 0%, respectively, which indicated no significant heterogeneity was present among the studies with respect to amnesia about the procedure (Fig. 6).

Complication rate There was no significant difference between the two groups with regard to hypoxia or hypotension. Hypoxia. Hypoxia as a complication was reported in six studies. The meta-analysis demonstrated that there was no significant difference between the two groups with regard to hypoxia (OR = 0.74 [95% CI: 0.49 to 1.12, P = 0.15]) (Fig. 7). Hypotension. Hypotension as a complication was reported in six studies. The meta-analysis demonstrated that there was no significant difference between the two groups with regard to hypotension (OR = 1.44 [95% CI: 0.86 to 2.42, P = 0.16]) (Fig. 8).

Publication bias Funnel plot analysis was conducted. The graphical funnel plot of the nine studies appeared to be symmetrical, which means the publication bias is unlikely in this meta-analysis (Fig. 9).

DISCUSSION

A

FTER REVIEWING THE most recent and best available evidence, our meta-analysis revealed that deep sedation with propofol is more favorable than traditional sedation for advanced endoscopic procedures, specifically with respect to recovery time, sedation level, intra-procedure patient cooperation, and the degree of amnesia about the procedure, without causing any significant increase in complication rate.

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Propofol Midazolam Propofol Midazolam Propofol Midazolam Propofol M/M Propofol Meperidine + Scopolamine Propofol M/M Propofol M/M Propofol M/M Propofol M/M

Wehrmann et al.14 Jung et al.30 Krugliak et al.34 Vargo et al.9 Chen et al.35 77 78 40 40 67 67 76 75

100 100 40 40 15 17 38 37 35 35

No. patients

Sex (female/male)

58/42 60/40 21/19 27/13 8/7 12/5 17/21 20/17 18/17 16/19 42/35 46/32 22/18 22/18 27/40 26/41 51/25 49/26

Age (mean ± SD)

63.6 ± 23.3 61.2 ± 20.5 62 (33–86)† 63 (3–88)† 56.8 ± 12.5 57.2 ± 17.9 52.9 ± 2.4 55.7 ± 2.6 53.89 ± 17 52.43 ± 13 83.7 ± 7.8 85.6 ± 8.1 54.1 ± 14.1 57.2 ± 12.6 52.9 ± 13.6 52.3 ± 11.9 82.4 (80–92)† 83.2 (80–96)† N/A N/A N/A N/A 23.21 ± 4.67‡ 24.42 ± 5.66‡ N/A N/A

N/A N/A 70 (50–100)† 69 (45–93)† 70.6 ± 13.4 69.0 ± 15.2 26.8 ± 5.4‡ 26.3 ± 5.4‡ N/A N/A

Weight (kg) (mean ± SD)

N/A N/A 16 15 N/A N/A 14 16

12 14 N/A N/A N/A N/A 2 5 N/A N/A

Alcohol use

N/A N/A 19 9 N/A N/A N/A N/A

N/A N/A N/A N/A N/A N/A 10 8 N/A N/A

Tobacco use

N/A N/A N/A N/A N/A N/A N/A N/A

18 16 N/A N/A N/A N/A 8 6 N/A N/A

Regular use of drugs (sedatives, psychotropic or narcotics)

N/A N/A 1 2 N/A N/A N/A N/A

2 2 N/A N/A N/A N/A 8 4 N/A N/A

Prior difficulty with sedation

Range given instead of SD. ‡Body mass index (BMI) given instead of weight. M/M, midazolam/meperidine; N/A, not available; ?, information not provided.



Riphaus et al.31 DeWitt et al.33 Kongkam et al.36 Schilling et al.32

Sedation

Study

Table 2 Patient characteristics of studies included in the meta-analysis

?/?/32/39 ?/?/29/42 N/A N/A 26/22/19/0 32/27/8/0 N/A N/A

N/A N/A 1/24/15/0 1/27/12/0 9/6/0/0 9/8/0/0 14/16/8/0 16/15/6/0 N/A N/A

American Society of Anesthesiologists (ASA) Grade I/II/III/IV

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Figure 2 Forest plot of meta-analysis comparing procedure time during propofol sedation and traditional sedative agents for advanced endoscopy procedures. CS, conscious sedation; MAC, monitored anesthesia care.

Figure 3 Forest plot of meta-analysis comparing recovery time during propofol sedation and traditional sedative agents for advanced endoscopy procedures. CS, conscious sedation; MAC, monitored anesthesia care.

Figure 4 Forest plot of meta-analysis comparing sedation level during propofol sedation and traditional sedative agents for advanced endoscopy procedures. CS, conscious sedation; MAC, monitored anesthesia care.

Several of our findings reinforce prior studies. The significant reduction in recovery time is consistent with the results of the subanalysis on ERCP done by Wang et al.28 and the meta-analysis done by Bo et al.37 Our analysis furthermore demonstrated significantly improved degree of patient cooperation (evaluated in four of the studies) and a statistically non-significant decrease in procedure duration with PDS compared to traditional sedatives.

Considering together the procedure time, recovery time and cooperation data in our meta-analysis suggests that PDS is the faster and more efficient sedation method, perhaps translating into improved cost-effectiveness over traditional sedation. Guidelines and a position statement published jointly by four American gastroenterology and hepatology societies report that non-anesthesiologist administration of propofol for gastrointestinal endoscopy is more

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Figure 5 Forest plot of meta-analysis comparing patient cooperation during procedures with propofol sedation and traditional sedative agents for advanced endoscopy procedures. CS, conscious sedation; MAC, monitored anesthesia care.

Figure 6 Forest plot of meta-analysis comparing amnesia regarding the procedure after propofol sedation and traditional sedative agents for advanced endoscopy procedures. CS, conscious sedation; MAC, monitored anesthesia care.

Figure 7 Forest plot of meta-analysis comparing hypoxia as a complication during propofol sedation and traditional sedative agents for advanced endoscopy procedures. CS, conscious sedation; MAC, monitored anesthesia care.

cost-effective than standard sedation with benzodiazepines and opioids.38 However, given that many advanced endoscopic procedures (such as the ones assessed here) are carried out under monitored-anesthesia care by an anesthesiologist, a decreased procedure time and recovery time of PDS may help offset the costs of extra monitoring and staffing. Further cost-effectiveness studies specifically evaluating advanced endoscopic procedures are needed.

Previous meta-analyses16,28,37 also demonstrated significantly fewer adverse effects of propofol sedation for colonoscopy and ERCP.16,28,37 We found an overall similar incidence of hypotension and hypoxia in advanced endoscopic procedures regardless of propofol sedation or traditional sedation. Our study differs from prior studies in that all advanced endoscopic procedures were considered for inclusion, with

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Figure 8 Forest plot of meta-analysis comparing hypotension as a complication during propofol sedation and traditional sedative agents for advanced endoscopy procedures. CS, conscious sedation; MAC, monitored anesthesia care.

Figure 9 Funnel plot of trials of propofol sedation and traditional sedative agents for advanced endoscopy procedures. MD, mean difference.

including criteria ultimately selecting studies on patients undergoing ERCP, EUS, and double-balloon enteroscopy for which there are few data.9,14,15 The applicability of the prior PDS studies7–11 on routine endoscopic procedures may be limited in such longer, more complex procedures. There are several limitations in our analysis. This was a study-level meta-analysis as opposed to an individual-level analysis, using already-aggregated summary values to extract our data and introducing heterogeneity in the data as well as bias from what those studies published. However, for propofol sedation during EUS, ERCP and deep small bowel enteroscopy, this study pooled all the available data from published RCT, which substantially reduced the type II error. Another limitation is that the included studies had variations in the

method of propofol administration (given in two studies by registered nurses, in two studies by intensive care unit [ICU] physicians, and in others by anesthesiologists). The included studies also evaluated different advanced endoscopic procedures, and only one evaluated deep enteroscopy. This may account for heterogeneity between the results of the studies. However, there were very few studies available in the published literature that met our inclusion criteria. Future studies should consider standardization of propofol administration and perhaps focus on a single type of advanced endoscopic procedure to further comment on specific subgroups (which were not individually analyzed here). Finally, one of the main goals of our study was to demonstrate the safety of propofol sedation, but the available studies had limited information

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regarding sedation-related adverse events other than hypotension and hypoxia (e.g. arrhythmias, apnea). Propofol has the potential to induce general anesthesia, and there is no pharmacological antagonist to reverse its effect. Although propofol sedation appears to be a promising safe strategy during ERCP, EUS and deep small bowel enteroscopy, the administrator should be aware of the risk of hypotension and respiratory depression.15 It is important to monitor these patients closely while they are under anesthesia. One such way is by using the bispectral index (BIS). It has been shown that BIS-guided anesthesia reduces the risk of intraoperative recall in surgical patients with a high risk of awareness. Also, anesthesia guided by the BIS within the recommended range may possibly improve anesthetic delivery and postoperative recovery from relatively deep anesthesia. These findings, however, are still under investigation.38 As the present meta-analysis supports the overall efficacy and safety of propofol sedation for advanced endoscopic procedures, future studies should compare and evaluate propofol given by anesthesiologists versus propofol given by non-anesthesiologists for safety and efficacy, paralleling the studies done on routine endoscopic procedures.

CONCLUSION

I

N CONCLUSION, PROPOFOL sedation during advanced endoscopic procedures leads to a shorter recovery time, better sedation level and better patient cooperation without an increase in cardiopulmonary side-effects. Propofol deep sedation seems to be an effective and safe method for providing adequate sedation during advanced endoscopic procedures.

CONFLICT OF INTERESTS

A

UTHORS DECLARE NO conflict of interests for this article.

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© 2013 The Authors Digestive Endoscopy © 2013 Japan Gastroenterological Endoscopy Society

Propofol versus traditional sedative agents for advanced endoscopic procedures: a meta-analysis.

The optimum method for sedation for advanced endoscopic procedures is not known. Propofol deep sedation has a faster recovery time than traditional se...
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