Ketofol Versus Propofol in Urgent ERCP for Acute Cholangitis

NCT04997967 | Unknown Phase 4

• 1 other identifier: Ketofol in Urgent ERCP
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Conscious Sedation Failure During Procedure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Impact of ketofol on hemodynamics

  24 hours

• Impact of ketofol on oxygen saturation

  24 hours

• Impact of ketofol on hemodynamics

  24 hours

Study Arms (2)

Ketofol group

EXPERIMENTAL

Patients undergoing urgent therapeutic ERCP for severe cholangitis, with American Society of Anaesthesiologist (ASA) Grade II - III. Will receive Ketofol (ketamine: propofol concentration 1:4) prepared in 50 ml syringe containing dextrose 5% (each ml contained 8 mg propofol and 2 mg ketamine), administered as following; 5 ml of ketofol as loading then infusion titrated till targeted RSS score.

Drug: Ketamine/Propofol

Propofol group

ACTIVE COMPARATOR

Patients undergoing urgent therapeutic ERCP for severe cholangitis, with American Society of Anaesthesiologist (ASA) Grade II - III. 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.

Drug: Propofol

Interventions

Ketamine/Propofol DRUG

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.

Ketofol group

Propofol DRUG

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.

Propofol group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, 71515, Egypt

RECRUITING

MeSH Terms

Interventions

Ketamine; Propofol

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic

Study Officials

• Haidi Ramadan, PhD

  faculty of medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haidi Ramadan, Phd

CONTACT

+201028186710; haidikaram@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: July 11, 2021
• First Posted: August 10, 2021
• Study Start: July 1, 2020
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: August 10, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)