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Trial record 2 of 3 for:    "Cholangiocarcinoma" | "Analgesics, Opioid"

Etomidate vs. Midazolam for Sedation During ERCP

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ClinicalTrials.gov Identifier: NCT02027311
Recruitment Status : Completed
First Posted : January 6, 2014
Results First Posted : June 29, 2015
Last Update Posted : June 29, 2015
Sponsor:
Information provided by (Responsible Party):
Byung Hyo Cha, MD, Cheju Halla General Hospital

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.


Condition or disease Intervention/treatment Phase
Choledocholithiasis Cholangiocarcinoma Pancreatitis Pancreatic Cancer Drug: Etomidate Drug: Midazolam Drug: Meperidine Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Etomidate With Meperidine vs Midazolam With Meperidine for Sedation During Endodscopic Retrograde Cholangiopancreatogram (ERCP)
Study Start Date : April 2013
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013


Arm Intervention/treatment
Experimental: 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.
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.
Other Name: Etomidate lipro IV

Drug: Meperidine
Both groups were administered same dose of meperidinie 50mg. Then elders > 80 years old were administered 25mg iv bolus.
Other Name: Pethidine

Experimental: 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%.
Drug: 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%.

Drug: Meperidine
Both groups were administered same dose of meperidinie 50mg. Then elders > 80 years old were administered 25mg iv bolus.
Other Name: Pethidine




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Event of Hypoxia [ Time Frame: Every 5min in Preoperative, intraoperative phase and 15 min in Recovery phase ]
    Hypoxia defined as peripheral blood oxygen saturation measured by pulse oxymeter < 90%



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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02027311


Locations
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Korea, Republic of
1Digestive Disease Center and Department of Internal Medicine, Cheju Halla General Hospital
Jeju-si, Jeju Special Self-Governing Province, Korea, Republic of, 690-766
Sponsors and Collaborators
Cheju Halla General Hospital
Investigators
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Study Chair: BYUNG HYO CHA, Dr. Cheju Halla General Hospital, Doreongno 65, Jeju-si Jeju Special Self-Governing Province, Korea 690-766

Publications:

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Responsible Party: Byung Hyo Cha, MD, Director of Endoscopy clinic, Digestive Disease Center, Department of Internal Medicine, Cheju Halla General Hospital
ClinicalTrials.gov Identifier: NCT02027311     History of Changes
Other Study ID Numbers: ETOMI-1
First Posted: January 6, 2014    Key Record Dates
Results First Posted: June 29, 2015
Last Update Posted: June 29, 2015
Last Verified: June 2015

Keywords provided by Byung Hyo Cha, MD, Cheju Halla General Hospital:
Endoscopic Retrograde Cholangiopancreatography (ERCP)
Conscious Sedation
etomidate
midazolam

Additional relevant MeSH terms:
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Cholangiocarcinoma
Analgesics, Opioid
Pancreatic Neoplasms
Pancreatitis
Choledocholithiasis
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Common Bile Duct Diseases
Bile Duct Diseases
Biliary Tract Diseases
Cholelithiasis
Midazolam
Meperidine
Etomidate
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs