CholedocholithiasisPhase 4NCT02027311
Etomidate vs. Midazolam for Sedation During ERCP
A Phase 4 study testing Etomidate, Midazolam and Meperidine in people with Choledocholithiasis and Cholangiocarcinoma, run by Cheju Halla General Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Choledocholithiasis, Cholangiocarcinoma, Pancreatitis
- What is being tested?
- Etomidate, Midazolam and Meperidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2013to Aug 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Refuse to be enrolled
- ASA American Society of Anesthesiologists)classification IV, V
- Breast feeder
- The mentally ill
- Drug abuser
- Hypersensitivity to sedative or opioids
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
1Digestive Disease Center and Department of Internal Medicine, Cheju Halla General Hospital
Jeju City, Jeju Special Self-Governing Province, 690-766
About this study
Official title: Etomidate With Meperidine vs Midazolam With Meperidine for Sedation During Endodscopic Retrograde Cholangiopancreatogram (ERCP)
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.
Read the detailed 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.
- Being tested
- Etomidate, Midazolam, Meperidine
- Keywords
- Endoscopic Retrograde Cholangiopancreatography (ERCP), Conscious Sedation, etomidate, midazolam
- Medical subject headings
- Choledocholithiasis, Cholangiocarcinoma, Pancreatitis, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtomidateDrug
Also called Etomidate lipro IV
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.
MidazolamDrug
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%.
MeperidineDrug
Also called Pethidine
Both groups were administered same dose of meperidinie 50mg. Then elders > 80 years old were administered 25mg iv bolus.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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%. Receives: Drug: Midazolam; Drug: Meperidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Throughout the whole ERCP procedure
Secondary outcomes (1)
Event of Hypoxia
Hypoxia defined as peripheral blood oxygen saturation measured by pulse oxymeter < 90%
Measured: Every 5min in Preoperative, intraoperative phase and 15 min in Recovery phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2014 (estimated)
- Study startApr 2013
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for CholedocholithiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cheju Halla General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Byung Hyo Cha, MD, Cheju Halla General Hospital
- Investigators
- BYUNG HYO CHA, Dr., Study chair, Cheju Halla General Hospital, Doreongno 65, Jeju-si Jeju Special Self-Governing Province, Korea 690-766
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02027311
- Sponsor's protocol ID
- ETOMI-1
- Status last verified
- Jun 2015
- First submitted
- 16 Apr 2013
- Last updated
- 29 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 18984096Yamazaki N, Ogawa K. [Dopamine-beta-hydroxylase (DBH)]. Kokyu To Junkan. 1976 Nov;24(11):949-55. No abstract available. Japanese.
PubMed 1034320Bell 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.
PubMed 2104078Galletly 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.
PubMed 3377928Yuksel 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.
PubMed 18049171Radaelli 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.
PubMed 12612511Reimann 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.
PubMed 10718390Sipe 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.
PubMed 12024134Riker 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.
PubMed 19188334Jung 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.
PubMed 10718389Falk 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.
PubMed 15173551Hunt 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.
PubMed 15915401Denny 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.
PubMed 22224127Miner 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.
PubMed 15692132Ruth 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.
PubMed 11136141
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etomidate With Meperidine vs Midazolam With Meperidine for Sedation During Endodscopic Retrograde Cholangiopancreatogram (ERCP)
- ClinicalTrials.gov ID
- NCT02027311
- Acronym / sponsor ID
- ETOMI-1
- Keywords
- Endoscopic Retrograde Cholangiopancreatography (ERCP), Conscious Sedation, etomidate, midazolam
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Cheju Halla General HospitalUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 6 Jan 2014 (estimated)
- Results
- Posted 29 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Etomidate | Experimental | Drug: Etomidate, Drug: MeperidineThis 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 | Drug: Midazolam, Drug: MeperidineThis 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%. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (14 listed)
- Refuse to be enrolled
- ASA American Society of Anesthesiologists)classification IV, V
- Breast feeder
- The mentally ill
- Drug abuser
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EtomidateAlso: Etomidate lipro IVThis 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 |
| MidazolamThis 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 |
| MeperidineAlso: PethidineBoth groups were administered same dose of meperidinie 50mg. Then elders > 80 years old were administered 25mg iv bolus. | Drug | Etomidate, Midazolam |
Primary outcome
Number of Intervention
Time frame: Throughout the whole ERCP procedure
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.
1 secondary outcome
Event of Hypoxia
Time frame: Every 5min in Preoperative, intraoperative phase and 15 min in Recovery phase
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18984096Standards 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.
- Background: PubMed 1034320Yamazaki N, Ogawa K. [Dopamine-beta-hydroxylase (DBH)]. Kokyu To Junkan. 1976 Nov;24(11):949-55. No abstract available. Japanese.
- Background: PubMed 2104078Bell 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.
- Background: PubMed 3377928Galletly 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.
- Background: PubMed 18049171Yuksel 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.
- Background: PubMed 12612511Radaelli 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.
- Background: PubMed 10718390Reimann 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.
- Background: PubMed 12024134Sipe 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.
- Background: PubMed 19188334Riker 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.
- Background: PubMed 10718389Jung 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.
- Background: PubMed 15173551Falk 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.
- Background: PubMed 15915401Hunt 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
BYUNG HYO CHA, Dr. study chair
Cheju Halla General Hospital, Doreongno 65, Jeju-si Jeju Special Self-Governing Province, Korea 690-766
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Etomidate, Midazolam and Meperidine in people with Choledocholithiasis and Cholangiocarcinoma, run by Cheju Halla General Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Intervention (time frame: Throughout the whole ERCP procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02027311, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2015.