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Etomidate vs. Midazolam for Sedation During ERCP

Primary Purpose

Choledocholithiasis, Cholangiocarcinoma, Pancreatitis

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Etomidate
Midazolam
Meperidine
Sponsored by
Cheju Halla General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Choledocholithiasis focused on measuring Endoscopic Retrograde Cholangiopancreatography (ERCP), Conscious Sedation, etomidate, midazolam

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Etomidate

Midazolam

Arm Description

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.

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%.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Event of Hypoxia
Hypoxia defined as peripheral blood oxygen saturation measured by pulse oxymeter < 90%

Full Information

First Posted
April 16, 2013
Last Updated
June 9, 2015
Sponsor
Cheju Halla General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02027311
Brief Title
Etomidate vs. Midazolam for Sedation During ERCP
Official Title
Etomidate With Meperidine vs Midazolam With Meperidine for Sedation During Endodscopic Retrograde Cholangiopancreatogram (ERCP)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cheju Halla General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Choledocholithiasis, Cholangiocarcinoma, Pancreatitis, Pancreatic Cancer
Keywords
Endoscopic Retrograde Cholangiopancreatography (ERCP), Conscious Sedation, etomidate, midazolam

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Etomidate
Arm Type
Experimental
Arm Description
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.
Arm Title
Midazolam
Arm Type
Experimental
Arm Description
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%.
Intervention Type
Drug
Intervention Name(s)
Etomidate
Other Intervention Name(s)
Etomidate lipro IV
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Midazolam
Intervention Description
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%.
Intervention Type
Drug
Intervention Name(s)
Meperidine
Other Intervention Name(s)
Pethidine
Intervention Description
Both groups were administered same dose of meperidinie 50mg. Then elders > 80 years old were administered 25mg iv bolus.
Primary Outcome Measure Information:
Title
Number of Intervention
Description
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.
Time Frame
Throughout the whole ERCP procedure
Secondary Outcome Measure Information:
Title
Event of Hypoxia
Description
Hypoxia defined as peripheral blood oxygen saturation measured by pulse oxymeter < 90%
Time Frame
Every 5min in Preoperative, intraoperative phase and 15 min in Recovery phase

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
BYUNG HYO CHA, Dr.
Organizational Affiliation
Cheju Halla General Hospital, Doreongno 65, Jeju-si Jeju Special Self-Governing Province, Korea 690-766
Official's Role
Study Chair
Facility Information:
Facility Name
1Digestive Disease Center and Department of Internal Medicine, Cheju Halla General Hospital
City
Jeju-si
State/Province
Jeju Special Self-Governing Province
ZIP/Postal Code
690-766
Country
Korea, Republic of

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Etomidate vs. Midazolam for Sedation During ERCP

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