Randomized Controlled Trial
Copyright ©The Author(s) 2015. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Mar 28, 2015; 21(12): 3671-3678
Published online Mar 28, 2015. doi: 10.3748/wjg.v21.i12.3671
Comparison of the efficacy and safety of sedation between dexmedetomidine-remifentanil and propofol-remifentanil during endoscopic submucosal dissection
Namo Kim, Young-Chul Yoo, Sang Kil Lee, Hyunzu Kim, Hyang Mi Ju, Kyeong Tae Min
Namo Kim, Young-Chul Yoo, Hyunzu Kim, Hyang Mi Ju, Kyeong Tae Min, Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul 120-752, South Korea
Sang Kil Lee, Department of Internal Medicine, Yonsei University College of Medicine, Seoul 120-752, South Korea
Hyunzu Kim, Department of Anesthesiology and Pain Medicine, Kangdong Sacred Heart Hospital, Hallym University College of Medicine, Seoul 134-701, South Korea
Author contributions: Kim N and Yoo YC contributed to conception and design, acquisition of data, or analysis and interpretation of data; Lee SK interpretation of data, revising the draft critically for important intellectual content; Kim H and Ju HM acquisition of data and analysis and interpretation of data; and Min KT substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data, and final approval of the version to be published.
Ethics approval: The study was reviewed and approved by the Institutional Review Board of Severance Hospital, Yonsei University Health System No. 4-2012-0621.
Clinical trial registration: This study is registered at http://ClinicalTrials.gov. The registration identification number is No. NCT01920113.
Informed consent: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest: The authors have no conflict-of-interest.
Data sharing: No additional data are available.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Kyeong Tae Min, MD, PhD, Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine, 50 Yonsei-ro, Seodaemun-gu, Seoul 120-752, South Korea. ktmin501@yuhs.ac
Telephone: +82-2-22274161 Fax: +82-2-22277897
Received: September 12, 2014
Peer-review started: September 14, 2014
First decision: October 14, 2014
Revised: November 17, 2014
Accepted: January 8, 2015
Article in press: January 8, 2015
Published online: March 28, 2015
Processing time: 198 Days and 16.2 Hours
Abstract

AIM: To compare the efficacy and safety of sedation protocols for endoscopic submucosal dissection (ESD) between dexmedetomidine-remifentanil and propofol-remifentanil.

METHODS: Fifty-nine patients scheduled for ESD were randomly allocated into a dexmedetomidine-remifentanil (DR) group or a propofol-remifentanil (PR) group. To control patient anxiety, dexmedetomidine or propofol was infused to maintain a score of 4-5 on the Modified Observer’s Assessment of Alertness/Sedation scale. Remifentanil was infused continuously at a rate of 6 μg/kg per hour in both groups. The ease of advancing the scope into the throat, gastric motility grading, and satisfaction of the endoscopist and patient were assessed. Hemodynamic variables and hypoxemic events were compared to evaluate patient safety.

RESULTS: Demographic data were comparable between the groups. The hemodynamic variables and pulse oximetry values were stable during the procedure in both groups despite a lower heart rate in the DR group. No oxygen desaturation events occurred in either group. Although advancing the scope into the throat was easier in the PR group (“very easy” 24.1% vs 56.7%, P = 0.010), gastric motility was more suppressed in the DR group (“no + mild” 96.6% vs 73.3%, P = 0.013). The endoscopists felt that the procedure was more favorable in the DR group (“very good + good” 100% vs 86.7%, P = 0.042), whereas patient satisfaction scores were comparable between the groups. En bloc resection was performed 100% of the time in both groups, and the complete resection rate was 94.4% in the DR group and 100% in the PR group (P = 0.477).

CONCLUSION: The efficacy and safety of dexmedetomidine and remifentanil were comparable to propofol and remifentanil during ESD. However, the endoscopists favored dexmedetomidine perhaps due to lower gastric motility.

Keywords: Dexmedetomidine; Efficacy; Peristalsis; Safety; Endoscopic submucosal dissection

Core tip: Propofol and remifentanil are effectively used for endoscopic procedures. However, deep sedation especially with propofol is frequently associated with cardiorespiratory complications; therefore, it is of interest to identify shallower yet equally effective sedation protocols. Dexmedetomidine allows sedation without respiratory depression, and has also been utilized for sedation for endoscopic procedures. This study compared the efficacy and safety between propofol-remifentanil and dexmedetomidine-remifentanil during endoscopic submucosal dissection (ESD) from the perspective of the endoscopist and the patient. We found that efficacy and safety of dexmedetomidine-remifentanil were comparable to propofol-remifentanil during ESD, but the endoscopists favored the dexmedetomidine-remifentanil regimen perhaps due to lower gastric motility.