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

Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04029831
• Other study ID #: IndonesiaUAnes038
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Analgesia

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