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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04029831
Other study ID # IndonesiaUAnes038
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2017
Est. completion date June 1, 2017

Study information

Verified date October 2019
Source Indonesia University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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


Recruitment information / eligibility

Status Completed
Enrollment 58
Est. completion date June 1, 2017
Est. primary completion date May 1, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Propofol 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

Locations

Country Name City State
Indonesia Cipto Mangunkusumo General Hospital Jakarta Pusat DKI Jakarta

Sponsors (1)

Lead Sponsor Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & Publications (2)

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 — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Level of Propofol Usage Level of propofol needed during the procedure 1 hour
Secondary Recovery Time Time needed to recover after the procedure 15 minutes
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