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)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04029831

Enrollment

Registered

2019-07-23

Start date

2017-03-01

Completion date

2017-06-01

Last updated

2019-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesia

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

Interventions

DRUGPropofol 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

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

Secondary

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

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026