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

NCT04029831 | Completed

• 1 other identifier: IndonesiaUAnes038
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Analgesia

Outcome Measures

Primary Outcomes (1)

• Level of Propofol Usage

  Level of propofol needed during the procedure

  1 hour

Secondary Outcomes (1)

• Recovery Time

  15 minutes

Study Arms (2)

K61

EXPERIMENTAL

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)

K41

EXPERIMENTAL

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)

Interventions

Propofol and Ketamine Mixture (Ketofol) DRUG

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

K41; K61

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Cipto Mangunkusumo General Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

Related Publications (2)

• 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.

  PMID: 25162687 RESULT

• 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.

  PMID: 27853681 RESULT

MeSH Terms

Conditions

Agnosia

Interventions

Propofol

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 19, 2019
• First Posted: July 23, 2019
• Study Start: March 1, 2017
• Primary Completion: May 1, 2017
• Study Completion: June 1, 2017
• Last Updated: October 23, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)