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Ketofol Versus Propofol in Urgent ERCP for Acute Cholangitis

Primary Purpose

Conscious Sedation Failure During Procedure

Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Ketamine/Propofol
Propofol
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Conscious Sedation Failure During Procedure

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Assiut UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ketofol group

Propofol group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Impact of ketofol on hemodynamics
Heart rate (beats/min)
Impact of ketofol on oxygen saturation
Pulse oximeter (SO2)
Impact of ketofol on hemodynamics
Blood pressure(mmHg)

Full Information

First Posted
July 11, 2021
Last Updated
August 6, 2021
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT04997967
Brief Title
Ketofol Versus Propofol in Urgent ERCP for Acute Cholangitis
Official Title
Ketofol Versus Propofol in Urgent ERCP for Acute Cholangitis: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
August 2021 (Anticipated)
Study Completion Date
August 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Conscious Sedation Failure During Procedure

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ketofol group
Arm Type
Experimental
Arm Description
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.
Arm Title
Propofol group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ketamine/Propofol
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
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.
Primary Outcome Measure Information:
Title
Efficacy of ketofol in sedation
Description
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.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Impact of ketofol on hemodynamics
Description
Heart rate (beats/min)
Time Frame
24 hours
Title
Impact of ketofol on oxygen saturation
Description
Pulse oximeter (SO2)
Time Frame
24 hours
Title
Impact of ketofol on hemodynamics
Description
Blood pressure(mmHg)
Time Frame
24 hours

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haidi Ramadan, Phd
Phone
+201028186710
Email
haidikaram@aun.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haidi Ramadan, PhD
Organizational Affiliation
faculty of medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assiut University
City
Assiut
ZIP/Postal Code
71515
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haidi Ramadan, rofessor
Phone
+0201028186710
Email
haidikaram@aun.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Direct contact with the PI

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Ketofol Versus Propofol in Urgent ERCP for Acute Cholangitis

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