NCT04490031

Evaluation of Ketamine as Sedative Agent in Endoscopic Retrograde Cholangiopancreatography (ERCP)

Randomized Control Study Evaluating Ketamine as Sedative Agent in Endoscopic Retrograde Cholangiopancreatography (ERCP)

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Universiti Kebangsaan Malaysia Medical Centre · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Accepted

Summary

This is a study evaluating the usage of Ketamine as sedative agent in ERCP. The usage of Ketamine will be compared to the standard sedation in our center, which is Midazolam in combination with Pethidine as analgesia.

Detailed description

This is a double blinded study whereby both the surgeons and patients are blinded from the sedative agent used. Patients admitted to UKMMC requiring ERCP will randomized into 2 groups after evaluating the inclusion and exclusion criteria. Patients will be divided into two arms, Midazolam and Ketamine group respectively. Before the initiation of the the scope, patient would be given specified dose of sedation accordingly. All the parameters and outcome would be measured during and after the procedure.

Conditions

• Ketamine Adverse Reaction

Interventions

Type	Name	Description
DRUG	Ketamine Hydrochloride	patient in Ketamine group will be given Ketamine as sedative agent

Timeline

• Start date: 2020-03-01
• Primary completion: 2020-12-31
• Completion: 2021-04-30
• First posted: 2020-07-28
• Last updated: 2020-07-28

Locations

1 site across 1 country: Malaysia

Regulatory

• FDA-regulated drug study