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Ketamine and Propofol for Upper Endoscopy

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ClinicalTrials.gov Identifier: NCT02295553
Recruitment Status : Completed
First Posted : November 20, 2014
Results First Posted : June 10, 2019
Last Update Posted : June 10, 2019
Sponsor:
Information provided by (Responsible Party):
Jason Hayes, The Hospital for Sick Children

Tracking Information
First Submitted Date  ICMJE December 12, 2013
First Posted Date  ICMJE November 20, 2014
Results First Submitted Date  ICMJE November 6, 2017
Results First Posted Date  ICMJE June 10, 2019
Last Update Posted Date June 10, 2019
Actual Study Start Date  ICMJE July 2013
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 8, 2019)
Dose of Propofol Required to Prevent Movement (Response) to Insertion of Endoscope Into the Patient's Esophagus [ Time Frame: This outcome is measured at the time of insertion of the endoscope into the esophagus. ]
The objective is to determine the effective bolus dose in 50% of subjects (ED50) of propofol in combination with ketamine 0, 0.25, 0.5 and 1 mg/kg that produces an adequate depth of anesthesia to prevent minimal or no movement on endoscope insertion in children
Original Primary Outcome Measures  ICMJE
 (submitted: November 17, 2014)
Movement (response)/no movement (no response) upon insertion of endoscope into the patient's esophagus [ Time Frame: From the time of insertion of the endoscope into the patient's mouth until endoscope enters the esophagus ]
The objective is to determine the effective bolus dose in 50% of subjects (ED50) of propofol in combination with ketamine 0, 0.25, 0.5 and 1 mg/kg that produces an adequate depth of anesthesia to prevent minimal or no movement on endoscope insertion in children
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 8, 2019)
  • Duration of Apnea After Propofol Administration [ Time Frame: This outcome will be measured after propofol is administered until the end of the procedure. ]
    The patient will be observed for apnea after propofol is administered until the endoscopy procedure is complete. Duration of apnea will be recorded.
  • Incidence of Adverse Respiratory Events During the Procedure [ Time Frame: From induction of anesthesia until endoscopy procedure is complete ]
    Any respiratory adverse event including desaturation <95 requiring oxygen administration or need for airway management maneuvers (jaw thrust, bag/mask ventilation) to relieve upper airway obstruction
  • Incidence of Side Effects and Complications During the Recovery Period [ Time Frame: From the time procedure is complete until discharge from hospital with an average time of 1 hour. ]
    Side effects including: hallucinations and/or emergence delirium measured by the Pediatric Anesthesia Emergence Delirium (PAED) scale dizziness nausea and/or vomiting administration of antiemetic pain > 3/10 at any site (measured using age appropriate scale) time to discharge readiness using established criteria reasons for delayed discharge (if any)
Original Secondary Outcome Measures  ICMJE
 (submitted: November 17, 2014)
  • Duration of Apnea After Propofol Administration [ Time Frame: From the time propofol is administered until the time endoscopy is complete ]
    The patient will be observed for apnea after propofol is administered until the endoscopy procedure is complete. Duration of apnea will be recorded
  • Incidence of Adverse Respiratory Events During the Procedure [ Time Frame: From induction of anesthesia until endoscopy procedure is complete ]
    Any respiratory adverse event including desaturation <95 requiring oxygen administration or need for airway management maneuvers (jaw thrust, bag/mask ventilation) to relieve upper airway obstruction
  • Total propofol dose required to complete the procedure [ Time Frame: From the time first dose of propofol is administered until the end of the procedure ]
    For each subject, once the response/no response to endoscope insertion has been determined, additional intravenous doses of propofol 0.5 mg/kg may be given at the discretion of the attending anesthesiologist.
  • Incidence of Side Effects and Complications During the Recovery Period [ Time Frame: From the time procedure is complete until discharge from hospital with an average time of 1 hour. ]
    Side effects including: hallucinations and/or emergence delirium measured by the Pediatric Anesthesia Emergence Delirium (PAED) scale dizziness nausea and/or vomiting administration of antiemetic pain > 3/10 at any site (measured using age appropriate scale) time to discharge readiness using established criteria reasons for delayed discharge (if any)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine and Propofol for Upper Endoscopy
Official Title  ICMJE Co-administration of Ketamine and Propofol for Upper Endoscopy in Children: a Dose-finding Study
Brief Summary The purpose of this study is to examine the dose-response relationship of ketamine in combination with propofol.
Detailed Description Direct visualization of the esophagus, stomach and small intestine is performed using a scope that is inserted while the patient is under under deep sedation or general anesthesia. The most common method of providing general anesthesia for upper endoscopy is intravenous administration of medications such as propofol, often in combination with other medications such as fentanyl, midazolam, remifentanil or ketamine. One study found that the combination of propofol and ketamine provides better conditions (less patient movement, more stable heart and breathing) but more side effects afterwards compared to propofol and fentanyl.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Anesthesia
Intervention  ICMJE
  • Drug: Ketamine
  • Drug: Propofol
Study Arms  ICMJE
  • Experimental: Ketamine 0 mg/kg
    Ketamine dose will be 0 mg/kg. Propofol dose for the first patient will be 4 mg/kg. Doses for the subsequent patients will increase or decrease by 1.6 mg/kg using the Dixon Up and Down method.
    Intervention: Drug: Propofol
  • Experimental: Ketamine 0.25 mg/kg
    Ketamine dose will be 0.25 mg/kg. Propofol dose for the first patient will be 3 mg/kg. Doses for the subsequent patients will increase or decrease by 1.2 mg/kg using the Dixon Up and Down method.
    Interventions:
    • Drug: Ketamine
    • Drug: Propofol
  • Experimental: Ketamine 0.5 mg/kg
    Ketamine dose will be 0.5 mg/kg. Propofol dose for the first patient will be 2.5 mg/kg. Doses for the subsequent patients will increase or decrease by 0.8 mg/kg using the Dixon Up and Down method.
    Interventions:
    • Drug: Ketamine
    • Drug: Propofol
  • Experimental: Ketamine 1.0 mg/kg
    Ketamine dose will be 1.0 mg/kg. Propofol dose for the first patient will be 2 mg/kg. Doses for the subsequent patients will increase or decrease by 0.4 mg/kg using the Dixon Up and Down method.
    Interventions:
    • Drug: Ketamine
    • Drug: Propofol
Publications * Hayes J, Matava C, Pehora C, El-Beheiry H, Jarvis S, Finkelstein Y. Determination of the median effective dose of propofol in combination with different doses of ketamine during gastro-duodenoscopy in children: a randomised controlled trial. Br J Anaesth. 2018 Aug;121(2):453-461. doi: 10.1016/j.bja.2018.03.037. Epub 2018 Jun 5.

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: November 17, 2014)
56
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 3-13 years
  • Receiving general anesthesia for upper endoscopy

Exclusion Criteria:

  • Known or possible difficult airway
  • BMI > 35
  • Weight < 10 kg
  • Sedative premedication required
  • Known contraindication to ketamine or propofol
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 13 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02295553
Other Study ID Numbers  ICMJE 1000036780
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jason Hayes, The Hospital for Sick Children
Study Sponsor  ICMJE The Hospital for Sick Children
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jason Hayes The Hospital for Sick Children
PRS Account The Hospital for Sick Children
Verification Date March 2019

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