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Evaluation of Ketamine as Sedative Agent in Endoscopic Retrograde Cholangiopancreatography (ERCP)

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ClinicalTrials.gov Identifier: NCT04490031
Recruitment Status : Recruiting
First Posted : July 28, 2020
Last Update Posted : July 28, 2020
Sponsor:
Information provided by (Responsible Party):
Universiti Kebangsaan Malaysia Medical Centre

Tracking Information
First Submitted Date  ICMJE March 24, 2020
First Posted Date  ICMJE July 28, 2020
Last Update Posted Date July 28, 2020
Actual Study Start Date  ICMJE March 1, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2020)
  • depth of sedation [ Time Frame: 1 hour ]
    based on Ramsay Sedation Scale, from a scale of 1-6.
    1. Patient is anxious and agitated or restless, or both
    2. Patient is co-operative, oriented, and tranquil
    3. Patient responds to commands only
    4. Patient exhibits brisk response to light glabellar tap or loud auditory stimulus
    5. Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus
    6. Patient exhibits no response The aim of sedation is a score of 3-4
  • completion rate [ Time Frame: 1 hour ]
    to evaluate completion rate between Ketamine and Midazolam group
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2020)
  • Surgeon satisfaction score [ Time Frame: within 4 hours after completion of ERCP ]
    subjective scoring of surgeon regarding overall experience of the ERCP from a score of 0-10. 0- poor, 5- moderate, 10- excellent
  • Patient satisfaction score [ Time Frame: within 4 hours after completion of ERCP ]
    subjective scoring of patients regarding overall experience of the ERCP from a score of 0-10. 0- poor, 5- moderate, 10- excellent
  • evaluate the occurrence of hypertension, hypotension, bradycardia, tachycardia, hypoxia, respiratory rate abnormality, nausea, vomiting and emergence symptoms [ Time Frame: 24 hours ]
    recording the adverse events of each sedation.
    1. Hypotension: defined as a systolic blood pressure drop greater than 20mmHg to a value less than 90mmHg
    2. Hypertension: defined as a systolic blood pressure increase greater than 20mmHg or to a value more than 140mmHg
    3. Bradycardia: defined as heart rate less than 50 after the initiation of sedation or decrease in heart rate more than 20 beats per minute
    4. Tachycardia: defined as heart rate more than 100 after the initiation of sedation or increase in heart rate more than 20 beats per minute
    5. Hypoxia: defined by oxygen saturation less than 95%
    6. Respiratory rate abnormality
    7. Nausea, vomiting, emergence symptoms
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 Evaluation of Ketamine as Sedative Agent in Endoscopic Retrograde Cholangiopancreatography (ERCP)
Official Title  ICMJE Randomized Control Study Evaluating Ketamine as Sedative Agent in Endoscopic Retrograde Cholangiopancreatography (ERCP)
Brief Summary This is a study evaluating the usage of Ketamine as sedative agent in ERCP. The usage of Ketamine will be compared to the standard sedation in our center, which is Midazolam in combination with Pethidine as analgesia.
Detailed Description This is a double blinded study whereby both the surgeons and patients are blinded from the sedative agent used. Patients admitted to UKMMC requiring ERCP will randomized into 2 groups after evaluating the inclusion and exclusion criteria. Patients will be divided into two arms, Midazolam and Ketamine group respectively. Before the initiation of the the scope, patient would be given specified dose of sedation accordingly. All the parameters and outcome would be measured during and after the procedure.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Masking Description:
Both the patients and surgeon will be blinded from knowing the sedative agent
Primary Purpose: Health Services Research
Condition  ICMJE Ketamine Adverse Reaction
Intervention  ICMJE Drug: Ketamine Hydrochloride
patient in Ketamine group will be given Ketamine as sedative agent
Study Arms  ICMJE
  • No Intervention: Midazolam group
    Standard sedation for ERCP in UKMMC
  • Experimental: Ketamine group
    Intervention: Drug: Ketamine Hydrochloride
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: July 24, 2020)
140
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2021
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Malaysian citizens of who is able to give valid consent
  • Patient planned for ERCP (either emergency or elective)

Exclusion Criteria:

  • Known hypersensitivity towards Ketamine or Midazolam
  • Patient refusal to participate or unable to give consent
  • Increased intracranial pressure, acute stroke (<3 months), intracranial haemorrhage (<3 months)
  • Uncontrolled hypertension (BP>160/100) and tachycardia (Heart rate >120)
  • Acute myocardial infarction, acute coronary syndrome (<3 months)
  • Tachyarrythmia
  • Pregnancy
  • IVDU or substance abuse patient
  • Patient with history of hallucination
  • Child's Pugh Class C
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Muhammad Hafiz Ismail, MBBS 6016 3354384 muhdhafizismail88@gmail.com
Contact: Ian Chik, MD 6012 3243404 ianchikmd@gmail.com
Listed Location Countries  ICMJE Malaysia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04490031
Other Study ID Numbers  ICMJE Hukm
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Universiti Kebangsaan Malaysia Medical Centre
Study Sponsor  ICMJE Universiti Kebangsaan Malaysia Medical Centre
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ian Chik, MD Universiti Kebangsaan Malaysia Medical Centre
Principal Investigator: Norma mohamad, MD Universiti Kebangsaan Malaysia Medical Centre
Principal Investigator: Zamri Zuhdi, MD Universiti Kebangsaan Malaysia Medical Centre
Principal Investigator: Azlanudin Azman, MD Universiti Kebangsaan Malaysia Medical Centre
Principal Investigator: Muhammad Hafiz Ismail, MD Universiti Kebangsaan Malaysia Medical Centre
PRS Account Universiti Kebangsaan Malaysia Medical Centre
Verification Date March 2020

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