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Completed

NCT Number: NCT04029831

Comparison of Different Ratio of 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

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cipto Mangunkusumo General Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Level of Propofol Usage

    Time frame: 1 hour

    Level of propofol needed during the procedure

Secondary outcomes

  1. Recovery Time

    Time frame: 15 minutes

    Time needed to recover after the procedure

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jul 23, 2019
Registry last updated
Oct 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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