Etomidate vs. Midazolam for Sedation During ERCP

Cheju Halla General Hospital

Status and phase: Completed; Phase 4

Conditions: Pancreatitis; Cholangiocarcinoma; Choledocholithiasis; Pancreatic Cancer

Treatments: Drug: Midazolam; Drug: Etomidate; Drug: Meperidine

Study type: Interventional

Funder types: Other

Identifiers

NCT02027311

ETOMI-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 63 patients

Sex: All

Ages: 20 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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63 participants in 2 patient groups

Etomidate

Experimental group

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.

Treatment:

Drug: Meperidine

Drug: Etomidate

Midazolam

Experimental group

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%.

Treatment:

Drug: Meperidine

Drug: Midazolam