Phase 4 N=68 Randomized Triple-blind Treatment

Etomidate vs. Midazolam for Sedation During ERCP

Choledocholithiasis · Cholangiocarcinoma · Pancreatitis · Pancreatic Cancer

Bottom Line

View on ClinicalTrials.gov: NCT02027311 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2015

Primary outcome: Primary: Number of Intervention — 1.9; 7.5 Number of intervention — p=0.05

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Etomidate (Drug); Midazolam (Drug); Meperidine (Drug)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: Cheju Halla General Hospital
Primary completion: Aug 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Intervention	1.9; 7.5	0.05
SECONDARY Event of Hypoxia	19; 27	0.002 sig

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02027311). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.