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)
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.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
Number of Intervention
Secondary Outcome
Event of Hypoxia
Condition
Choledocholithiasis
Intervention
Etomidate
Study Arms / Comparison Groups
Etomidate
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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
63
Start Date
April 2013
Completion Date
August 2013
Primary Completion Date
August 2013
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
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.
Gender
All
Ages
20 Years - 90 Years
Accepts Healthy Volunteers
No
Contacts
BYUNG HYO CHA, Dr., ,
Location Countries
Korea, Republic of
Location Countries
Korea, Republic of
Administrative Informations
NCT ID
NCT02027311
Organization ID
ETOMI-1
Responsible Party
Principal Investigator
Study Sponsor
Cheju Halla General Hospital
Study Sponsor
BYUNG HYO CHA, Dr., Study Chair, Cheju Halla General Hospital, Doreongno 65, Jeju-si Jeju Special Self-Governing Province, Korea 690-766
Verification Date
June 2015