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Ketofol Versus Propofol in Urgent ERCP for Acute Cholangitis

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ClinicalTrials.gov Identifier: NCT04997967
Recruitment Status : Recruiting
First Posted : August 10, 2021
Last Update Posted : August 10, 2021
Sponsor:
Information provided by (Responsible Party):
Haidi Karam, Assiut University

Tracking Information
First Submitted Date  ICMJE July 11, 2021
First Posted Date  ICMJE August 10, 2021
Last Update Posted Date August 10, 2021
Actual Study Start Date  ICMJE July 1, 2020
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 6, 2021)
Efficacy of ketofol in sedation [ Time Frame: 24 hours ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 6, 2021)
  • Impact of ketofol on hemodynamics [ Time Frame: 24 hours ]
    Heart rate (beats/min)
  • Impact of ketofol on oxygen saturation [ Time Frame: 24 hours ]
    Pulse oximeter (SO2)
  • Impact of ketofol on hemodynamics [ Time Frame: 24 hours ]
    Blood pressure(mmHg)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketofol Versus Propofol in Urgent ERCP for Acute Cholangitis
Official Title  ICMJE Ketofol Versus Propofol in Urgent ERCP for Acute Cholangitis: A Randomized Controlled Trial
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Conscious Sedation Failure During Procedure
Intervention  ICMJE
  • 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.
  • Drug: 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.
Study Arms  ICMJE
  • Experimental: Ketofol group
    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.
    Intervention: Drug: Ketamine/Propofol
  • Active Comparator: Propofol group
    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: Drug: Propofol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 6, 2021)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2021
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Haidi Ramadan, Phd +201028186710 haidikaram@aun.edu.eg
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04997967
Other Study ID Numbers  ICMJE Ketofol in Urgent ERCP
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Direct contact with the PI
Responsible Party Haidi Karam, Assiut University
Study Sponsor  ICMJE Assiut University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Haidi Ramadan, PhD faculty of medicine
PRS Account Assiut University
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP