Etomidate vs. Midazolam for Sedation During ERCP

NCT02027311 | Completed Phase 4 Results DMC

• 1 other identifier: ETOMI-1
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

Recently up-coming drug, etomidate which is a modulator of GABA(gamma-Aminobutyric acid)-A receptor has been known that it maintains the appropriate sedative levels and affects little effects on respiratory system. The investigators are now trying to investigate that etomidate with meperidine combination regimen is superior to the midazolam with meperidine more effective and less harm on sedation during the ERCP procedure.

Conditions

Choledocholithiasis; Cholangiocarcinoma; Pancreatitis; Pancreatic Cancer

Keywords

Endoscopic Retrograde Cholangiopancreatography (ERCP); Conscious Sedation; etomidate; midazolam

Outcome Measures

Primary Outcomes (1)

• Number of Intervention

  The frequency of intervention which was defined as any restraint of the patient's head, arms, or legs if they became agitated, or if patient movement was not controlled with verbal instruction from the endoscopist during the whole intraoperative phases.

  Throughout the whole ERCP procedure

Secondary Outcomes (1)

• Event of Hypoxia

  Every 5min in Preoperative, intraoperative phase and 15 min in Recovery phase

Study Arms (2)

Etomidate

EXPERIMENTAL

This cohort would be administered etomidate with meperidine. The initial dose of etomidate is 0.1mg/kg IV and meperidine, 25mg. Additional dose of etomidate is 2mg(1cc). In old age cased, more than 65 years old, 30% of initial dose discounted.

Drug: Etomidate; Drug: Meperidine

Midazolam

EXPERIMENTAL

This cohort would be administered midazolam with meperidine. The initial dose of midazolam is 0.06mg/kg IV and meperidine 50mg IV. Additional dose is 1mg of midazolam. In the elders, more than 65 years old, initial dose was declined to 70%.

Drug: Midazolam; Drug: Meperidine

Interventions

Etomidate DRUG

This cohort would be administered etomidate with meperidine. The initial dose of etomidate is 0.1mg/kg IV and meperidine, 25mg. Additional dose of etomidate is 2mg(1cc). In old age cased, more than 65 years old, 30% of initial dose discounted.

Also known as: Etomidate lipro IV

Etomidate

Midazolam DRUG

This cohort would be administered midazolam with meperidine. The initial dose of midazolam is 0.06mg/kg IV and meperidine 50mg IV. Additional dose is 1mg of midazolam. In the elders, more than 65 years old, initial dose was declined to 70%.

Midazolam

Meperidine DRUG

Both groups were administered same dose of meperidinie 50mg. Then elders \> 80 years old were administered 25mg iv bolus.

Also known as: Pethidine

Etomidate; Midazolam

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients who are scheduled diagnositic or therapeutic ERCP.
• Age : more than 20 and less than 90 years old
• ASA(American Society of Anesthesiologists) classificiation : I, II, III

You may not qualify if:

• Refuse to be enrolled
• ASA American Society of Anesthesiologists)classification IV, V
• Breast feeder
• The mentally ill
• Drug abuser
• Hypersensitivity to sedative or opioids
• Alcohol intoxication or dependency
• Body mass index (BMI) 36kg/m2 or more
• Unstable vital sign
• tachypnea, respiration rate more than 25/min or less than 10/min
• Oxygen saturation : 90% or less
• Systolic blood pressure : less than 90 mmHg or more than 180 mmHg
• Diastolic blood pressure : less than 50 mmHg or more than 100 mmHg
• Heart rate : more than 120 beat/min or less than 50 beat/min.

Sponsors & Collaborators

• Cheju Halla General Hospital: lead

Study Sites (1)

1Digestive Disease Center and Department of Internal Medicine, Cheju Halla General Hospital

Jeju City, Jeju Special Self-Governing Province, 690-766, South Korea

Location

Related Publications (26)

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• Yuksel O, Parlak E, Koklu S, Ertugrul I, Tunc B, Sahin B. Conscious sedation during endoscopic retrograde cholangiopancreatography: midazolam or midazolam plus meperidine? Eur J Gastroenterol Hepatol. 2007 Nov;19(11):1002-6. doi: 10.1097/MEG.0b013e3282cf5167.

  PMID: 18049171 BACKGROUND

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  PMID: 12024134 BACKGROUND

• Riker RR, Shehabi Y, Bokesch PM, Ceraso D, Wisemandle W, Koura F, Whitten P, Margolis BD, Byrne DW, Ely EW, Rocha MG; SEDCOM (Safety and Efficacy of Dexmedetomidine Compared With Midazolam) Study Group. Dexmedetomidine vs midazolam for sedation of critically ill patients: a randomized trial. JAMA. 2009 Feb 4;301(5):489-99. doi: 10.1001/jama.2009.56. Epub 2009 Feb 2.

  PMID: 19188334 BACKGROUND

• Jung M, Hofmann C, Kiesslich R, Brackertz A. Improved sedation in diagnostic and therapeutic ERCP: propofol is an alternative to midazolam. Endoscopy. 2000 Mar;32(3):233-8. doi: 10.1055/s-2000-96.

  PMID: 10718389 BACKGROUND

• Falk J, Zed PJ. Etomidate for procedural sedation in the emergency department. Ann Pharmacother. 2004 Jul-Aug;38(7-8):1272-7. doi: 10.1345/aph.1E008. Epub 2004 Jun 1.

  PMID: 15173551 BACKGROUND

• Hunt GS, Spencer MT, Hays DP. Etomidate and midazolam for procedural sedation: prospective, randomized trial. Am J Emerg Med. 2005 May;23(3):299-303. doi: 10.1016/j.ajem.2005.02.042.

  PMID: 15915401 BACKGROUND

• Denny MA, Manson R, Della-Giustina D. Propofol and Etomidate are Safe for Deep Sedation in the Emergency Department. West J Emerg Med. 2011 Nov;12(4):399-403. doi: 10.5811/westjem.2011.5.2099.

  PMID: 22224127 BACKGROUND

• Miner JR, Martel ML, Meyer M, Reardon R, Biros MH. Procedural sedation of critically ill patients in the emergency department. Acad Emerg Med. 2005 Feb;12(2):124-8. doi: 10.1197/j.aem.2004.08.054.

  PMID: 15692132 BACKGROUND

• Ruth WJ, Burton JH, Bock AJ. Intravenous etomidate for procedural sedation in emergency department patients. Acad Emerg Med. 2001 Jan;8(1):13-8. doi: 10.1111/j.1553-2712.2001.tb00539.x.

  PMID: 11136141 BACKGROUND

• Mandt MJ, Roback MG, Bajaj L, Galinkin JL, Gao D, Wathen JE. Etomidate for short pediatric procedures in the emergency department. Pediatr Emerg Care. 2012 Sep;28(9):898-904. doi: 10.1097/PEC.0b013e318267c768.

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• Terui T, Inomata M. Administration of additional analgesics can decrease the incidence of paradoxical reactions in patients under benzodiazepine-induced sedation during endoscopic transpapillary procedures: prospective randomized controlled trial. Dig Endosc. 2013 Jan;25(1):53-9. doi: 10.1111/j.1443-1661.2012.01325.x. Epub 2012 Jun 11.

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• Honan VJ. Paradoxical reaction to midazolam and control with flumazenil. Gastrointest Endosc. 1994 Jan-Feb;40(1):86-8. doi: 10.1016/s0016-5107(94)70020-6. No abstract available.

  PMID: 8163147 BACKGROUND

• Ladas SD, Aabakken L, Rey JF, Nowak A, Zakaria S, Adamonis K, Amrani N, Bergman JJ, Boix Valverde J, Boyacioglu S, Cremers I, Crowe J, Deprez P, Dite P, Eisen M, Eliakim R, Fedorov ED, Galkova Z, Gyokeres T, Heuss LT, Husic-Selimovic A, Khediri F, Kuznetsov K, Marek T, Munoz-Navas M, Napoleon B, Niemela S, Pascu O, Perisic N, Pulanic R, Ricci E, Schreiber F, Svendsen LB, Sweidan W, Sylvan A, Teague R, Tryfonos M, Urbain D, Weber J, Zavoral M; European Society of Gastrointestinal Endoscopy Survey of National Endoscopy Society Members. Use of sedation for routine diagnostic upper gastrointestinal endoscopy: a European Society of Gastrointestinal Endoscopy Survey of National Endoscopy Society Members. Digestion. 2006;74(2):69-77. doi: 10.1159/000097466. Epub 2006 Nov 27.

  PMID: 17135728 BACKGROUND

• Cohen LB, Wecsler JS, Gaetano JN, Benson AA, Miller KM, Durkalski V, Aisenberg J. Endoscopic sedation in the United States: results from a nationwide survey. Am J Gastroenterol. 2006 May;101(5):967-74. doi: 10.1111/j.1572-0241.2006.00500.x.

  PMID: 16573781 BACKGROUND

• Riphaus A, Rabofski M, Wehrmann T. Endoscopic sedation and monitoring practice in Germany: results from the first nationwide survey. Z Gastroenterol. 2010 Mar;48(3):392-7. doi: 10.1055/s-0028-1109765. Epub 2010 Feb 5.

  PMID: 20140841 BACKGROUND

• Fanti L, Agostoni M, Casati A, Guslandi M, Giollo P, Torri G, Testoni PA. Target-controlled propofol infusion during monitored anesthesia in patients undergoing ERCP. Gastrointest Endosc. 2004 Sep;60(3):361-6. doi: 10.1016/s0016-5107(04)01713-4.

  PMID: 15332024 BACKGROUND

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  PMID: 16109532 BACKGROUND

• Kongkam P, Rerknimitr R, Punyathavorn S, Sitthi-Amorn C, Ponauthai Y, Prempracha N, Kullavanijaya P. Propofol infusion versus intermittent meperidine and midazolam injection for conscious sedation in ERCP. J Gastrointestin Liver Dis. 2008 Sep;17(3):291-7.

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• Carrasco G. Instruments for monitoring intensive care unit sedation. Crit Care. 2000;4(4):217-25. doi: 10.1186/cc697. Epub 2000 Jul 13.

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• Frade Mera MJ, Guirao Moya A, Esteban Sanchez ME, Rivera Alvarez J, Cruz Ramos AM, Bretones Chorro B, Vinas Sanchez S, Jacue Izquierdo S, Montane Lopez M. [Analysis of 4 sedation rating scales in the critical patient]. Enferm Intensiva. 2009 Jul-Sep;20(3):88-94. doi: 10.1016/s1130-2399(09)72588-x. Spanish.

  PMID: 19775565 BACKGROUND

MeSH Terms

Conditions

Choledocholithiasis; Cholangiocarcinoma; Pancreatitis; Pancreatic Neoplasms

Interventions

Etomidate; Midazolam; Meperidine

Condition Hierarchy (Ancestors)

Common Bile Duct Diseases; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Cholelithiasis; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Pancreatic Diseases; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Isonipecotic Acids; Acids, Heterocyclic; Piperidines

Limitations and Caveats

1. To standardize proper sedation level we used Ramsay Sedation Scale but this scale could be calculated subjectively. 2. Double blindness was not applied strictly because of quite different pharmacodynamics of two experimental drugs.

Results Point of Contact

• Title: Dr. Byung Hyo Cha, Director of ETOMI-1 study
• Organization: Digestive Disease Center and Department of Internal Medicine, Cheju Halla General Hospital

drhyo@hotmail.com

+82-64-740-8050

Study Officials

• BYUNG HYO CHA, Dr.

  Cheju Halla General Hospital, Doreongno 65, Jeju-si Jeju Special Self-Governing Province, Korea 690-766

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Endoscopy clinic, Digestive Disease Center, Department of Internal Medicine

Study Record Dates

• First Submitted: April 16, 2013
• First Posted: January 6, 2014
• Study Start: April 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: June 29, 2015
• Results First Posted: June 29, 2015

Record last verified: 2015-06

Locations

KR (1)