Ketofol Versus Propofol in Urgent ERCP for Acute Cholangitis

Conscious Sedation Failure During Procedure Clinical Trial

Official title:

Ketofol Versus Propofol in Urgent ERCP for Acute Cholangitis: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04997967
• Other study ID #: Ketofol in Urgent ERCP
• Status: Recruiting
• Phase: Phase 4
• Start date: July 1, 2020
• Est. completion date: August 2021

Study information

• Verified date: August 2021
• Source: Assiut University
• Contact: Haidi Ramadan, Phd
• Phone: +201028186710
• Email: haidikaram[@]aun.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Endoscopic Retrograde Cholangiopancreatography (ERCP) is a lengthy and uncomfortable procedure that requires adequate sedation. Propofol is the commonly used sedative during ERCP. However, dose dependent cardiac and respiratory depression may occur. Hypotension usually occurs in severe cholangitis which necessitate the use of alternative sedative. The aim is to study the efficacy and safety of ketofol as a sedative during urgent ERCP for severe cholangitis.

Description:

This randomized controlled trial was carried out on 96 patients undergoing urgent ERCP for severe cholangitis. Patients were allocated into two groups; group 1: received ketofol and group 2: received propofol. Demographic data, ERCP duration, recovery time, heart rate (HR), mean arterial pressure (MAP), peripheral oxygen saturation, Ramsey Sedation Scale (RSS), pain Numerical Rating Scale (NRS), propofol requirement, adverse events, endoscopists and patients satisfaction were recorded

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Severe acute cholangitis of either sex

• Aged between 21-70 years

• Undergoing urgent therapeutic ERCP for severe cholangitis with American Society of Anaesthesiologist (ASA) Grade II - III.

Exclusion Criteria:

• Patients who had ASA physical status Grade VI,

• Baseline SpO2 <90%,

• Patients who had difficulty in communication,

• Patients allergic to the studied medications,

• Morbidly obese patients,

• Patients with chronic obstructive pulmonary disease,

• Complicated airway,

• Pregnant patients.

Related Conditions & MeSH terms

• Cholangitis
• Conscious Sedation Failure During Procedure

Intervention

Drug:
• Ketamine/Propofol
The level of sedation was assessed at 1-3 min intervals, and the infusion rate was adjusted accordingly to achieve a Ramsay Sedation Scale (RSS) score of 5. Any movement of the patient was treated by increasing infusion rate and the infusion was discontinued at the end of the procedure. The total propofol consumed was calculated and the recovery time was recorded and calculated as the time from discontinuation of infusion of the study drug till achievement of RSS score of 3. Then patients were discharged to post-anesthesia care unit (PACU) after attaining an Aldrete Recovery Scale Score of 9- 10 [19]. Time taken to achieve this score was also recorded.
• Propofol
Sedation was initially started by bolus dose of 0.5 mg/kg propofol IV over 3 minutes then, infusion was started at the rate of 50 µg /kg/min till RSS score of 5.

Locations

Country	Name	City	State
Egypt	Assiut University	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of ketofol in sedation	The time to reach Ramsay Sedation Scale score of 5 to ensure adequate sedation. This scale is between 1-6.; The score 5 and 6 indicates adequate sedation while score <5 indicates inadequate sedation.	24 hours
Secondary	Impact of ketofol on hemodynamics	Heart rate (beats/min)	24 hours
Secondary	Impact of ketofol on oxygen saturation	Pulse oximeter (SO2)	24 hours
Secondary	Impact of ketofol on hemodynamics	Blood pressure(mmHg)	24 hours