Etomidate vs. Midazolam for Sedation During ERCP

Pancreatic Cancer Clinical Trial

Official title:

Etomidate With Meperidine vs Midazolam With Meperidine for Sedation During Endodscopic Retrograde Cholangiopancreatogram (ERCP)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02027311
• Other study ID #: ETOMI-1
• Status: Completed
• Phase: Phase 4
• First received: April 16, 2013
• Last updated: June 9, 2015
• Start date: April 2013
• Est. completion date: August 2013

Study information

• Verified date: June 2015
• Source: Cheju Halla General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 90 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Choledocholithiasis
• Pancreatic Cancer
• Pancreatic Neoplasms
• Pancreatitis

Intervention

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.
• 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%.
• Meperidine
Both groups were administered same dose of meperidinie 50mg. Then elders > 80 years old were administered 25mg iv bolus.

Locations

Country	Name	City	State
Korea, Republic of	1Digestive Disease Center and Department of Internal Medicine, Cheju Halla General Hospital	Jeju-si	Jeju Special Self-Governing Province

Sponsors (1)

Lead Sponsor	Collaborator
Cheju Halla General Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (26)

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* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Throughout the whole ERCP procedure	Yes
Secondary	Event of Hypoxia	Hypoxia defined as peripheral blood oxygen saturation measured by pulse oxymeter < 90%	Every 5min in Preoperative, intraoperative phase and 15 min in Recovery phase	Yes