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

Comparing the Effect of Different Ratio of Propofol-Ketamine Mixture (Ketofol) (6:1 vs. 4:1) for Sedation in Endoscopic Retrograde Cholangiopancreatography (ERCP)

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

Study Overview

• Status: Completed
• Conditions: Analgesia
• Intervention / Treatment: Drug: Propofol and Ketamine Mixture (Ketofol)

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 Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
      • Cipto Mangunkusumo General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: K61; 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).	Drug: Propofol and Ketamine Mixture (Ketofol); Each group was given Ketofol, but group K61 received mixture of propofol and ketamine in a ratio of 6:1 while K41 received 4:1
Experimental: K41; 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).	Drug: Propofol and Ketamine Mixture (Ketofol); Each group was given Ketofol, but group K61 received mixture of propofol and ketamine in a ratio of 6:1 while K41 received 4:1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of Propofol Usage	Level of propofol needed during the procedure	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recovery Time	Time needed to recover after the procedure	15 minutes

Collaborators and Investigators

• Sponsor: Indonesia University

Publications and helpful links

General Publications

• Coulter FL, Hannam JA, Anderson BJ. Ketofol dosing simulations for procedural sedation. Pediatr Emerg Care. 2014 Sep;30(9):621-30. doi: 10.1097/PEC.0000000000000222.
• Bahrami Gorji F, Amri P, Shokri J, Alereza H, Bijani A. Sedative and Analgesic Effects of Propofol-Fentanyl Versus Propofol-Ketamine During Endoscopic Retrograde Cholangiopancreatography: A Double-Blind Randomized Clinical Trial. Anesth Pain Med. 2016 Aug 22;6(5):e39835. doi: 10.5812/aapm.39835. eCollection 2016 Oct.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: July 19, 2019
• First Submitted That Met QC Criteria: July 19, 2019
• First Posted (Actual): July 23, 2019

Study Record Updates

• Last Update Posted (Actual): October 23, 2019
• Last Update Submitted That Met QC Criteria: October 22, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Hypnotics and Sedatives; Ketamine; Propofol
• Other Study ID Numbers: IndonesiaUAnes038

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No