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Published in: Digestive Diseases and Sciences 6/2018

01-06-2018 | Original Article

Efficacy of a Dexmedetomidine–Remifentanil Combination Compared with a Midazolam–Remifentanil Combination for Conscious Sedation During Therapeutic Endoscopic Retrograde Cholangio-Pancreatography: A Prospective, Randomized, Single-Blinded Preliminary Trial

Authors: Zhiqiang Lu, Wenyuan Li, Huiyu Chen, Yanning Qian

Published in: Digestive Diseases and Sciences | Issue 6/2018

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Abstract

Background

Dexmedetomidine as a conscious sedative exhibits both analgesia and respiratory sparing effects.

Aims

We evaluated and compared the sedative effect and the safety of a dexmedetomidine–remifentanil (DR) regimen with a midazolam–remifentanil (MR) combination during the endoscopic retrograde cholangio-pancreatography (ERCP) requiring conscious sedation.

Methods

One-hundred and ninety-eight patients were randomized and divided into two groups. A bolus of midazolam (0.05 mg kg−1) was injected intravenously for MR group, and dexmedetomidine (1 μg kg−1) was pumping for 10 min for DR group. Next, an initial loading dose of 1 μg kg−1 and 0.05–0.2 μg kg−1 min−1 of remifentanil was administered in all patients. Hemodynamic and respiratory changes, Ramsay Sedation Scale, Visual Analogue Scale, endoscopist and patient satisfaction were assessed. Furthermore, adverse events as well as recovery time and discharge time were rated.

Results

Patient satisfaction scores were significantly higher in the DR group compared with MR group. The occurrence of desaturation was statistically higher, and the operation time was longer in the MR group. Although no statistically significant values could be determined between the two groups about amnesia and need of additional drug, the DR group was found to require a significantly reduced amount of extra midazolam. Furthermore, nausea during catheterization of oropharynx was found to be more pronounced in the DR group.

Conclusions

The dexmedetomidine–remifentanil protocol provided a parallel sedative efficacy and improved respiratory sparing effects. The higher patient satisfaction scores potentially offer a more reproducible ERCP quality. Adding dexmedetomidine to remifentanil can be used safely as a conscious sedation method during ERCP.
Literature
1.
go back to reference Mazzon D, Germanà B, Poole D, et al. Conscious sedation during endoscopic retrograde colangiopancreatography: implementation of SIED-SIAARTI-ANOTE guidelines in Belluno Hospital. Minerva Anestesiol. 2005;71:101–109.PubMed Mazzon D, Germanà B, Poole D, et al. Conscious sedation during endoscopic retrograde colangiopancreatography: implementation of SIED-SIAARTI-ANOTE guidelines in Belluno Hospital. Minerva Anestesiol. 2005;71:101–109.PubMed
2.
go back to reference Belleville JP, Ward DS, Bloor BC, Maze M. Effects of IV dexmedetomidine in humans. I. Sedation, ventilation, and metabolic rate. Anesthesiology. 1992;77:1125–1133.CrossRefPubMed Belleville JP, Ward DS, Bloor BC, Maze M. Effects of IV dexmedetomidine in humans. I. Sedation, ventilation, and metabolic rate. Anesthesiology. 1992;77:1125–1133.CrossRefPubMed
3.
go back to reference Ebert TJ, Hall JE, Barney JA, Uhrich TD, Colinco MD. The effects of increasing plasma concentrations of dexmedetomidine in humans. Anesthesiology. 2000;93:382–394.CrossRefPubMed Ebert TJ, Hall JE, Barney JA, Uhrich TD, Colinco MD. The effects of increasing plasma concentrations of dexmedetomidine in humans. Anesthesiology. 2000;93:382–394.CrossRefPubMed
4.
go back to reference Venn RM, Hell J, Grounds RM. Respiratory effects of dexmedetomidine in the surgical subject requiring intensive care. Crit Care Med. 2000;4:302–308. Venn RM, Hell J, Grounds RM. Respiratory effects of dexmedetomidine in the surgical subject requiring intensive care. Crit Care Med. 2000;4:302–308.
5.
go back to reference Goksu S, Arik H, Demiryurek S, et al. Effects of dexmedetomidine infusion in patients undergoing functional endoscopic sinus surgery under local anaesthesia. Eur J Anaesthesiol. 2008;25:22–28.CrossRefPubMed Goksu S, Arik H, Demiryurek S, et al. Effects of dexmedetomidine infusion in patients undergoing functional endoscopic sinus surgery under local anaesthesia. Eur J Anaesthesiol. 2008;25:22–28.CrossRefPubMed
6.
go back to reference Dere K, Sucullu I, Budak ET, et al. A comparison of dexmedetomidine versus midazolam for sedation, pain and hemodynamic control, during colonoscopy under conscious sedation. Eur J Anaesthesiol. 2010;27:648–652.CrossRefPubMed Dere K, Sucullu I, Budak ET, et al. A comparison of dexmedetomidine versus midazolam for sedation, pain and hemodynamic control, during colonoscopy under conscious sedation. Eur J Anaesthesiol. 2010;27:648–652.CrossRefPubMed
7.
go back to reference Muller S, Borowics SM, Fortis EA, et al. Clinical efficacy of dexmedetomidine alone is less than propofol for conscious sedation during ERCP. Gastrointest Endosc. 2008;67:651–659.CrossRefPubMed Muller S, Borowics SM, Fortis EA, et al. Clinical efficacy of dexmedetomidine alone is less than propofol for conscious sedation during ERCP. Gastrointest Endosc. 2008;67:651–659.CrossRefPubMed
8.
go back to reference Chen WX, Lin HJ, Zhang WF, et al. Sedation and safety of propofol for therapeutic endoscopic retrograde cholangiopancreatography. Hepatobiliary Pancreat Dis Int. 2005;4:437–440.PubMed Chen WX, Lin HJ, Zhang WF, et al. Sedation and safety of propofol for therapeutic endoscopic retrograde cholangiopancreatography. Hepatobiliary Pancreat Dis Int. 2005;4:437–440.PubMed
9.
go back to reference Lee BS, Ryu J, Lee SH, et al. Midazolam with meperidine and dexmedetomidine versus midazolam with meperidine for sedation during ERCP: prospective, randomized, double-blinded trial. Endoscopy. 2014;46:291–298.CrossRefPubMed Lee BS, Ryu J, Lee SH, et al. Midazolam with meperidine and dexmedetomidine versus midazolam with meperidine for sedation during ERCP: prospective, randomized, double-blinded trial. Endoscopy. 2014;46:291–298.CrossRefPubMed
10.
go back to reference Nishizawa T, Suzuki H, Matsuzaki J, Kanai T, Yahagi N. Propofol versus traditional sedative agents for endoscopic submucosal dissection: a systematic review. Dig Endosc. 2014;26:701–706.CrossRefPubMed Nishizawa T, Suzuki H, Matsuzaki J, Kanai T, Yahagi N. Propofol versus traditional sedative agents for endoscopic submucosal dissection: a systematic review. Dig Endosc. 2014;26:701–706.CrossRefPubMed
11.
go back to reference Habib NE, Mandour NM, Balmer HG. Effects of midazolam on anxiety level and pain perception in cataract surgery with topical anesthesia. J Cataract Refract Surg. 2004;30:437–443.CrossRefPubMed Habib NE, Mandour NM, Balmer HG. Effects of midazolam on anxiety level and pain perception in cataract surgery with topical anesthesia. J Cataract Refract Surg. 2004;30:437–443.CrossRefPubMed
12.
go back to reference Lee SP, Sung IK, Kim JH, et al. Comparison of dexmedetomidine with on-demand midazolam versus midazolam alone for procedural sedation during endoscopic submucosal dissection of gastric tumor. J Dig Dis. 2015;16:377–384.CrossRefPubMed Lee SP, Sung IK, Kim JH, et al. Comparison of dexmedetomidine with on-demand midazolam versus midazolam alone for procedural sedation during endoscopic submucosal dissection of gastric tumor. J Dig Dis. 2015;16:377–384.CrossRefPubMed
13.
go back to reference Egan TD, Lemmens HJ, Fiset P, et al. The pharmacokinetics of the new shortacting opioid remifentanil (GI87084B) in healthy adult male volunteers. Anesthesiology. 1993;79:881–892.CrossRefPubMed Egan TD, Lemmens HJ, Fiset P, et al. The pharmacokinetics of the new shortacting opioid remifentanil (GI87084B) in healthy adult male volunteers. Anesthesiology. 1993;79:881–892.CrossRefPubMed
14.
go back to reference Kapila A, Glass PS, Jacobs JR, et al. Measured context-sensitive half-times of remifentanil and alfentanil. Anesthesiology. 1995;83:968–975.CrossRefPubMed Kapila A, Glass PS, Jacobs JR, et al. Measured context-sensitive half-times of remifentanil and alfentanil. Anesthesiology. 1995;83:968–975.CrossRefPubMed
15.
go back to reference Westmoreland CL, Hoke JF, Sebel PS, Hug CC Jr, Muir KT. Pharmacokinetics of remifentanil (GI87084B) and its major metabolite (GI90291) in patients undergoing elective inpatient surgery. Anesthesiology. 1993;79:893–903.CrossRefPubMed Westmoreland CL, Hoke JF, Sebel PS, Hug CC Jr, Muir KT. Pharmacokinetics of remifentanil (GI87084B) and its major metabolite (GI90291) in patients undergoing elective inpatient surgery. Anesthesiology. 1993;79:893–903.CrossRefPubMed
16.
go back to reference Kim N, Yoo YC, Lee SK, Kim H, Ju HM, Min KT. Comparison of the efficacy and safety of sedation between dexmedetomidine-remifentanil and propofol-remifentanil during endoscopic submucosal dissection. World J Gastroenterol. 2015;21:3671–3678.CrossRefPubMedPubMedCentral Kim N, Yoo YC, Lee SK, Kim H, Ju HM, Min KT. Comparison of the efficacy and safety of sedation between dexmedetomidine-remifentanil and propofol-remifentanil during endoscopic submucosal dissection. World J Gastroenterol. 2015;21:3671–3678.CrossRefPubMedPubMedCentral
17.
go back to reference Kilic N, Sahin S, Aksu H, et al. Conscious sedation for endoscopic retrograde cholangiopancreatography: dexmedetomidine versus midazolam. Eurasian J Med. 2011;43:13–17.CrossRefPubMedPubMedCentral Kilic N, Sahin S, Aksu H, et al. Conscious sedation for endoscopic retrograde cholangiopancreatography: dexmedetomidine versus midazolam. Eurasian J Med. 2011;43:13–17.CrossRefPubMedPubMedCentral
18.
go back to reference Alhashemi JA. Dexmedetomidine versus midazolam for monitored anaesthesia care during cataract surgery. Br J Anaesth. 2006;96:722–726.CrossRefPubMed Alhashemi JA. Dexmedetomidine versus midazolam for monitored anaesthesia care during cataract surgery. Br J Anaesth. 2006;96:722–726.CrossRefPubMed
19.
go back to reference Maze M, Tranquilli W. Alpha-2 adrenoceptor agonists: defining the role in clinical anesthesia. Anesthesiology. 1991;74:581–605.CrossRefPubMed Maze M, Tranquilli W. Alpha-2 adrenoceptor agonists: defining the role in clinical anesthesia. Anesthesiology. 1991;74:581–605.CrossRefPubMed
20.
go back to reference Kuhar MJ, Unnerstall JR. Mapping receptors for alpha 2-agonists in the central nervous system. J Cardiovasc Pharmacol. 1984;6:S536–S542.CrossRefPubMed Kuhar MJ, Unnerstall JR. Mapping receptors for alpha 2-agonists in the central nervous system. J Cardiovasc Pharmacol. 1984;6:S536–S542.CrossRefPubMed
21.
go back to reference Von Delius S, Salletmaier H, Meining A, et al. Bispectral index monitoring of midazolam and propofol sedation during endoscopic retrograde cholangiopancreatography: a randomized clinical trial (the EndoBIS study). Endoscopy. 2012;44:258–264.CrossRef Von Delius S, Salletmaier H, Meining A, et al. Bispectral index monitoring of midazolam and propofol sedation during endoscopic retrograde cholangiopancreatography: a randomized clinical trial (the EndoBIS study). Endoscopy. 2012;44:258–264.CrossRef
22.
go back to reference Mukhopadhyay S, Niyogi M, Sarkar J, Mukhopadhyay BS, Halder SK. The dexmedetomidine “augmented” sedatoanalgesic cocktail: an effective approach for sedation in prolonged endoscopic retrograde cholangiopancreatography. J Anaesthesiol Clin Pharmacol. 2015;31:201–206.CrossRefPubMedPubMedCentral Mukhopadhyay S, Niyogi M, Sarkar J, Mukhopadhyay BS, Halder SK. The dexmedetomidine “augmented” sedatoanalgesic cocktail: an effective approach for sedation in prolonged endoscopic retrograde cholangiopancreatography. J Anaesthesiol Clin Pharmacol. 2015;31:201–206.CrossRefPubMedPubMedCentral
23.
go back to reference Jang SY, Park HG, Jung MK, et al. Bispectral index monitoring as an adjunct to nurse-administered combined sedation during endoscopic retrograde cholangiopancreatography. World J Gastroenterol. 2012;18:6284–6289.CrossRefPubMedPubMedCentral Jang SY, Park HG, Jung MK, et al. Bispectral index monitoring as an adjunct to nurse-administered combined sedation during endoscopic retrograde cholangiopancreatography. World J Gastroenterol. 2012;18:6284–6289.CrossRefPubMedPubMedCentral
24.
go back to reference el-Bitar N, Sfeir S. Evaluation of remifentanil in endoscopic retrograde cholangio-pancreatography. Middle East J Anaesthesiol. 2006;18:1209–1216.PubMed el-Bitar N, Sfeir S. Evaluation of remifentanil in endoscopic retrograde cholangio-pancreatography. Middle East J Anaesthesiol. 2006;18:1209–1216.PubMed
25.
go back to reference Zhang J, Huang Y, Li Z, Li J, Liu K, Li C. Sedation and use of analgesics in endoscopic retrograde cholangiopancreatography: a double-blind comparison study of meperidine/midazolam, remifentanil/midazolam, and remifentanil alone. Int J Clin Pharmacol Ther. 2016;54:872–879.CrossRefPubMed Zhang J, Huang Y, Li Z, Li J, Liu K, Li C. Sedation and use of analgesics in endoscopic retrograde cholangiopancreatography: a double-blind comparison study of meperidine/midazolam, remifentanil/midazolam, and remifentanil alone. Int J Clin Pharmacol Ther. 2016;54:872–879.CrossRefPubMed
26.
go back to reference Goyal R, Hasnain S, Mittal S, Shreevastava S. A randomized, controlled trial to compare the efficacy and safety profile of a dexmedetomidine-ketamine combination with a propofol–fentanyl combination for ERCP. Gastrointest Endosc. 2016;83:928–933.CrossRefPubMed Goyal R, Hasnain S, Mittal S, Shreevastava S. A randomized, controlled trial to compare the efficacy and safety profile of a dexmedetomidine-ketamine combination with a propofol–fentanyl combination for ERCP. Gastrointest Endosc. 2016;83:928–933.CrossRefPubMed
27.
go back to reference Ramkiran S, Iyer SS, Dharmavaram S, Mohan CV, Balekudru A, Kunnavil R. BIS targeted propofol sparing effects of dexmedetomidine versus ketamine in outpatient ERCP: a prospective randomised controlled trial. J Clin Diagn Res. 2015;9:UC07-12.PubMed Ramkiran S, Iyer SS, Dharmavaram S, Mohan CV, Balekudru A, Kunnavil R. BIS targeted propofol sparing effects of dexmedetomidine versus ketamine in outpatient ERCP: a prospective randomised controlled trial. J Clin Diagn Res. 2015;9:UC07-12.PubMed
Metadata
Title
Efficacy of a Dexmedetomidine–Remifentanil Combination Compared with a Midazolam–Remifentanil Combination for Conscious Sedation During Therapeutic Endoscopic Retrograde Cholangio-Pancreatography: A Prospective, Randomized, Single-Blinded Preliminary Trial
Authors
Zhiqiang Lu
Wenyuan Li
Huiyu Chen
Yanning Qian
Publication date
01-06-2018
Publisher
Springer US
Published in
Digestive Diseases and Sciences / Issue 6/2018
Print ISSN: 0163-2116
Electronic ISSN: 1573-2568
DOI
https://doi.org/10.1007/s10620-018-5034-3

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