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

University of Indonesia (UI)

Status: Completed

Conditions: Analgesia

Treatments: Drug: Propofol and Ketamine Mixture (Ketofol)

Study type: Interventional

Funder types: Other

Identifiers

NCT04029831

IndonesiaUAnes038

Details and patient eligibility

About

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

Full 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

Enrollment: 58 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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58 participants in 2 patient groups

K61

Experimental group

Description:

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).

Treatment:

Drug: Propofol and Ketamine Mixture (Ketofol)

K41

Experimental group

Description:

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).

Treatment:

Drug: Propofol and Ketamine Mixture (Ketofol)