Cocktail Sedation Containing Propofol Versus Conventional Sedation for Endoscopic Retrograde Cholangiopancreatography (ERCP)

King Chulalongkorn Memorial Hospital

Status and phase: Completed; Phase 4

Conditions: Disorders of Gallbladder, Biliary Tract and Pancreas

Treatments: Drug: propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT01540084

PA-001

Details and patient eligibility

About

Endoscopic retrograde cholangiopancreatography (ERCP) practically requires moderate to deep sedation by a combination of benzodiazepine and opioid. Propofol as a sole agent may cause oversedation. A combination (cocktail) of infused propofol, meperidine, and midazolam can reduce the dosage of propofol and may result in a lower risk of oversedation. The investigators prospectively compare the efficacy, recovery time, patient satisfactory, and side effects between cocktail and conventional sedations in patients undergoing ERCP.

Full description

ERCP patients were prospectively randomized into 2 groups; the cocktail group and the controls. For induction, a combination of 25 mg of meperidine and 2.5 mg of midazolam were injected in both groups. In the cocktail group, a bolus dose of propofol 1 mg/kg was administered and continuously infused. In the controls, 25 mg of meperidine or 2.5 mg/kg of midazolam were titrated to maintain the level of sedation.

Enrollment: 205 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients scheduled for ERCP

Exclusion criteria

• Age under 18 years
• American Society of Anesthesiologists' (ASA) physical classification IV - V
• History of sulfite, egg or soy bean allergy
• Emergency need for ERCP
• Informed consent could not be obtained

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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205 participants in 2 patient groups

conventional group

Active Comparator group

Description:

For induction, 25 mg of meperidine and 2.5 mg of midazolam were administered. To maintain conscious level of patient at moderate or deep level, 25 mg of meperidine and/or 2.5 mg of midazolam were administered as necessary.

Treatment:

Drug: propofol

cocktail group

Experimental group

Description:

For induction, 25 mg of meperidine and 2.5 mg of midazolam were administered. To maintain conscious level of patient at moderate or deep level, 1% propofol at the rate of 1 mg/kg/hr was administered. An additional 0.5 mg/kg bolus was administered as needed to achieve the designed conscious level.

Treatment:

Drug: propofol