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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02027311
Other study ID # ETOMI-1
Secondary ID
Status Completed
Phase Phase 4
First received April 16, 2013
Last updated June 9, 2015
Start date April 2013
Est. completion date August 2013

Study information

Verified date June 2015
Source Cheju Halla General Hospital
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Description:

ERCP (Endoscopic retrograde cholangiopancreatogram) is an uncomfortable and time-consuming procedure compared to other endoscopic procedures. Most ERCP procedure had been performed in sedation using tranquilizers and pain-killers.

Until recently, midazolam and opioid combination regimen recognized as a standard therapy is widely used, but the sedative effect is insufficient and intermittent paradoxical reaction has been questioned. Another drug, such as propofol, has been known that the sedative effect is superior one of the midazolam but disappointed due to narrow therapeutic range of respiratory distress and absence of antagonist. Meanwhile, recently up-coming drug, etomidate which is a modulator of GABA-A receptor has been known that it maintains the appropriate sedative levels and affects little effects on respiratory system.

For these advantages, this short acting sedative drug has been widely used in the emergency room during minor operation and in the operation room for induction. However, research on the efficacy during ERCP was not yet published.

In this regards, the purpose of the investigators study is to prove the efficacy of etomidate for sedation and to establish new evidence based sedation guidelines during ERCP procedure.


Recruitment information / eligibility

Status Completed
Enrollment 63
Est. completion date August 2013
Est. primary completion date August 2013
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 90 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:Patients following

- 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

1. tachypnea, respiration rate more than 25/min or less than 10/min

2. Oxygen saturation : 90% or less

3. Systolic blood pressure : less than 90 mmHg or more than 180 mmHg

4. Diastolic blood pressure : less than 50 mmHg or more than 100 mmHg

5. Heart rate : more than 120 beat/min or less than 50 beat/min.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Drug:
Etomidate
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.
Midazolam
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%.
Meperidine
Both groups were administered same dose of meperidinie 50mg. Then elders > 80 years old were administered 25mg iv bolus.

Locations

Country Name City State
Korea, Republic of 1Digestive Disease Center and Department of Internal Medicine, Cheju Halla General Hospital Jeju-si Jeju Special Self-Governing Province

Sponsors (1)

Lead Sponsor Collaborator
Cheju Halla General Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (26)

Bell GD. Review article: premedication and intravenous sedation for upper gastrointestinal endoscopy. Aliment Pharmacol Ther. 1990 Apr;4(2):103-22. Review. — View Citation

Carrasco G. Instruments for monitoring intensive care unit sedation. Crit Care. 2000;4(4):217-25. Epub 2000 Jul 13. Review. — View Citation

Chen WX, Lin HJ, Zhang WF, Gu Q, Zhong XQ, Yu CH, Li YM, Gu ZY. Sedation and safety of propofol for therapeutic endoscopic retrograde cholangiopancreatography. Hepatobiliary Pancreat Dis Int. 2005 Aug;4(3):437-40. — View Citation

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. — View Citation

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. — View Citation

Falk J, Zed PJ. Etomidate for procedural sedation in the emergency department. Ann Pharmacother. 2004 Jul-Aug;38(7-8):1272-7. Epub 2004 Jun 1. Review. — View Citation

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. — View Citation

Frade Mera MJ, Guirao Moya A, Esteban Sánchez ME, Rivera Alvarez J, Cruz Ramos AM, Bretones Chorro B, Viñas Sánchez S, Jacue Izquierdo S, Montane López M. [Analysis of 4 sedation rating scales in the critical patient]. Enferm Intensiva. 2009 Jul-Sep;20(3):88-94. Spanish. — View Citation

Galletly D, Forrest P, Purdie G. Comparison of the recovery characteristics of diazepam and midazolam. Br J Anaesth. 1988 Apr;60(5):520-4. — View Citation

Honan VJ. Paradoxical reaction to midazolam and control with flumazenil. Gastrointest Endosc. 1994 Jan-Feb;40(1):86-8. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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, Díte 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. Epub 2006 Nov 27. — View Citation

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. — View Citation

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. — View Citation

Radaelli F, Meucci G, Terruzzi V, Spinzi G, Imperiali G, Strocchi E, Lenoci N, Terreni N, Mandelli G, Minoli G. Single bolus of midazolam versus bolus midazolam plus meperidine for colonoscopy: a prospective, randomized, double-blind trial. Gastrointest Endosc. 2003 Mar;57(3):329-35. — View Citation

Reimann FM, Samson U, Derad I, Fuchs M, Schiefer B, Stange EF. Synergistic sedation with low-dose midazolam and propofol for colonoscopies. Endoscopy. 2000 Mar;32(3):239-44. — View Citation

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. — View Citation

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. — View Citation

Ruth WJ, Burton JH, Bock AJ. Intravenous etomidate for procedural sedation in emergency department patients. Acad Emerg Med. 2001 Jan;8(1):13-8. — View Citation

Sipe BW, Rex DK, Latinovich D, Overley C, Kinser K, Bratcher L, Kareken D. Propofol versus midazolam/meperidine for outpatient colonoscopy: administration by nurses supervised by endoscopists. Gastrointest Endosc. 2002 Jun;55(7):815-25. Erratum in: Gastrointest Endosc 2002 Aug;56(2):324. — View Citation

Standards of Practice Committee of the American Society for Gastrointestinal Endoscopy, Lichtenstein DR, Jagannath S, Baron TH, Anderson MA, Banerjee S, Dominitz JA, Fanelli RD, Gan SI, Harrison ME, Ikenberry SO, Shen B, Stewart L, Khan K, Vargo JJ. Sedation and anesthesia in GI endoscopy. Gastrointest Endosc. 2008 Nov;68(5):815-26. doi: 10.1016/j.gie.2008.09.029. — View Citation

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. — View Citation

Yamazaki N, Ogawa K. [Dopamine-beta-hydroxylase (DBH)]. Kokyu To Junkan. 1976 Nov;24(11):949-55. Japanese. — View Citation

Yüksel O, Parlak E, Köklü S, Ertugrul I, Tunç B, Sahin B. Conscious sedation during endoscopic retrograde cholangiopancreatography: midazolam or midazolam plus meperidine? Eur J Gastroenterol Hepatol. 2007 Nov;19(11):1002-6. — View Citation

* Note: There are 26 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Yes
Secondary Event of Hypoxia Hypoxia defined as peripheral blood oxygen saturation measured by pulse oxymeter < 90% Every 5min in Preoperative, intraoperative phase and 15 min in Recovery phase Yes
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