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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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%. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| BYUNG HYO CHA, Dr. | Cheju Halla General Hospital, Doreongno 65, Jeju-si Jeju Special Self-Governing Province, Korea 690-766 | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1Digestive Disease Center and Department of Internal Medicine, Cheju Halla General Hospital | Jeju City | Jeju Special Self-Governing Province | 690-766 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18984096 | Background | 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. No abstract available. | |
| 1034320 |
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68 patients were enrolled and 35 were assigned in the MDZ group and 33 were in the ETM group. In ETM group, 1 case was dropped due to hypotension and 2 were desaturation. And 1 cases was dropped due to tachycardia and 1 were desaturation in MDZ group.
Eligibility was evaluated for all patients with a scheduled ERCP procedure in the Cheju Halla General Hospital during the study period from May 15 2013 to Aug 19 2013. Sample size estimated 26 of each groups for reject null hypothesis with probability (power) 0.8 and Type I error is 0.05.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. Meperidine: Both groups were administered same dose of meperidinie 50mg. Then elders > 80 years old were administered 25mg iv bolus. |
| FG001 | 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%. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. Meperidine: Both groups were administered same dose of meperidinie 50mg. Then elders > 80 years old were administered 25mg iv bolus. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | Number of intervention | Throughout the whole ERCP procedure |
|
BP, RR, HR, and SpO2 were monitored at 5-minute intervals after the baseline measurements until the termination of the ERCP. The baseline measurements were obtained at least 15 minutes before any medication was administered to patients.
Additional probable side events, such as, paradoxic reaction in MDZ group, and myoclonus in ETM group were counted during the whole 3 phases of procedure.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. Meperidine: Both groups were administered same dose of meperidinie 50mg. Then elders > 80 years old were administered 25mg iv bolus. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Byung Hyo Cha, Director of ETOMI-1 study | Digestive Disease Center and Department of Internal Medicine, Cheju Halla General Hospital | +82-64-740-8050 | drhyo@hotmail.com |
Not provided
| ID | Term |
|---|---|
| D042883 | Choledocholithiasis |
| D018281 | Cholangiocarcinoma |
| D010195 | Pancreatitis |
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D003137 | Common Bile Duct Diseases |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D005045 | Etomidate |
| D008874 | Midazolam |
| D008614 | Meperidine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| 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%. |
|
| Meperidine | Drug | Both groups were administered same dose of meperidinie 50mg. Then elders > 80 years old were administered 25mg iv bolus. |
|
|
| Background |
| Yamazaki N, Ogawa K. [Dopamine-beta-hydroxylase (DBH)]. Kokyu To Junkan. 1976 Nov;24(11):949-55. No abstract available. Japanese. |
| 2104078 | Background | Bell GD. Review article: premedication and intravenous sedation for upper gastrointestinal endoscopy. Aliment Pharmacol Ther. 1990 Apr;4(2):103-22. doi: 10.1111/j.1365-2036.1990.tb00455.x. |
| 3377928 | Background | Galletly D, Forrest P, Purdie G. Comparison of the recovery characteristics of diazepam and midazolam. Br J Anaesth. 1988 Apr;60(5):520-4. doi: 10.1093/bja/60.5.520. |
| 18049171 | Background | 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. |
| 12612511 | Background | 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. doi: 10.1067/mge.2003.104. |
| 10718390 | Background | 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. doi: 10.1055/s-2000-134. |
| 12024134 | Background | 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. doi: 10.1067/mge.2002.124636. |
| 19188334 | 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. |
| 10718389 | 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. |
| 15173551 | 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. |
| 15915401 | 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. |
| 22224127 | 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. |
| 15692132 | 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. |
| 11136141 | 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. |
| 22929142 | 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. |
| 23286257 | Background | 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. |
| 8163147 | Background | 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. |
| 17135728 | 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. |
| 16573781 | 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. |
| 20140841 | 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. |
| 15332024 | 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. |
| 16109532 | Background | 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. |
| 18836622 | 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. |
| 11094504 | Background | Carrasco G. Instruments for monitoring intensive care unit sedation. Crit Care. 2000;4(4):217-25. doi: 10.1186/cc697. Epub 2000 Jul 13. |
| 19775565 | Background | 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. |
| BG001 | 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%. 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Body Mass Index (kg/square of m.) | Mean | Standard Deviation | kg/square of m. |
|
| Procedure Time (min) | Mean | Standard Deviation | min |
|
| OG001 | 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%. 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. |
|
|
|
| Secondary | Event of Hypoxia | Hypoxia defined as peripheral blood oxygen saturation measured by pulse oxymeter < 90% | Posted | Number | Hypoxia events | Every 5min in Preoperative, intraoperative phase and 15 min in Recovery phase |
|
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | 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%. 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. | 0 | 33 | 0 | 33 |
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| D002769 | Cholelithiasis |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D010182 | Pancreatic Diseases |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004701 | Endocrine Gland Neoplasms |
| D004700 | Endocrine System Diseases |
| D001569 |
| Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D007540 | Isonipecotic Acids |
| D000147 | Acids, Heterocyclic |
| D010880 | Piperidines |
| No |
| Superiority or Other |