Comparison of Different Ratio of Ketofol (6:1 vs. 4:1) for Sedation in Endoscopic Retrograde Cholangiopancreatography (ERCP)

Not Applicable

Completed

• Conditions: Analgesia
• Interventions: Drug: Propofol and Ketamine Mixture (Ketofol)

• Registration Number: NCT04029831
• Lead Sponsor: Indonesia University

Brief Summary

Study was aimed to compare the effect of ketofol between 6:1 and 4:1 ratio in patients who underwent ERCP

Detailed Description

Combination of propofol and ketamine (ketofol) has been used as a medication for sedation in various medical procedures such as Endoscopic Retrograde Cholangio-pancreatography (ERCP). The addition of ketamine to propofol may counteract the effect of respiratory and cardiovascular depression of propofol. There has been limited studies evaluating the sedation effect of different ketofol dose ratios associated with hemodynamic changes, recovery time, dose and side effect. Thus, the study was aimed to compare the effect of ketofol between 6:1 and 4:1 ratio in patients who underwent ERCP

Study Timeline

• Study Start: 2017-03-01
• Primary Completion: 2017-05-01
• Study Completion: 2017-06-01
• Study First Submitted: 2019-07-19
• Study First Submitted QC: 2019-07-19
• Study First Posted: 2019-07-23
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-22
• Last Update Posted: 2019-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

• Having ERCP procedures using sedatives
• ASA (American Society of Anesthesiologist) physical status Class I to III
• Body mass index (BMI) of 18-30 kg/m2
• Willing to participate in the study

Exclusion Criteria

• Patients with a history of allergic reaction to medications used in the study
• Patients with cardiovascular disease, uncontrolled hypertension, respiratory dysfunction
• Patients with unstable hemodynamic
• Patients with psychiatric medications
• Patients with probability of difficult intubation and ventilation Patients with kidney disorder Pregnant women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
K41	Propofol and Ketamine Mixture (Ketofol)	Patients in K41 group received propofol and ketamine in a ratio of 4:1. The 4:1 ketofol mixture was made by combining 20 mL of 1% propofol (10 mg/mL) and 1 mL ketamine (50 mg/ml). Afterward, 29 mL of 0.9% NaCl was added until the volume of mixture was 50 mL. Mixtures were mixed in a 50 mL syringe and were given to patients through a syringe pump (B Braun).
K61	Propofol and Ketamine Mixture (Ketofol)	Patients in K61 group received propofol and ketamine in a ratio of 6:1. The 6:1 ketofol mixture was made by mixing 30 mL of 1% propofol (10 mg/mL) and 1 mL of ketamine (50 mg/ml), then 19 mL of 0.9% NaCl was added until the volume of the mixture was 50 mL. The 4:1 ketofol mixture was made by combining 20 mL of 1% propofol (10 mg/mL) and 1 mL ketamine (50 mg/ml). Afterward, 29 mL of 0.9% NaCl was added until the volume of mixture was 50 mL. Mixtures were mixed in a 50 mL syringe and were given to patients through a syringe pump (B Braun).

Primary Outcome Measures

Name	Time	Method
Level of Propofol Usage	1 hour	Level of propofol needed during the procedure

Secondary Outcome Measures

Name	Time	Method
Recovery Time	15 minutes	Time needed to recover after the procedure

Trial Locations

Locations (1)

Cipto Mangunkusumo General Hospital; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia