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

Indonesia University58 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Analgesia

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Cipto Mangunkusumo General Hospital

Jakarta Pusat, DKI Jakarta, Indonesia

Outcomes

Primary Outcomes

Level of Propofol Usage

Level of propofol needed during the procedure

Time frame: 1 hour

Secondary Outcomes

Recovery Time

Time needed to recover after the procedure

Time frame: 15 minutes

Data from ClinicalTrials.gov

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