Ketamine and Propofol for Upper Endoscopy

Ketamine

Brief Summary

The purpose of this study is to examine the dose-response relationship of ketamine in combination with propofol.

Intervention / Treatment

  • Ketamine (DRUG)
    N/A
  • Propofol (DRUG)
    N/A

Condition or Disease

  • Anesthesia

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 3 Years to 13 Years
    Enrollment: 56 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    DOUBLE:
    • Participant
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Jul 01, 2013 ACTUAL
    Primary Completion: Dec 01, 2016 ACTUAL
    Completion Date: Dec 01, 2016 ACTUAL
    Study First Posted: Nov 20, 2014 ESTIMATED
    Results First Posted: Jun 10, 2019 ACTUAL
    Last Updated: Mar 08, 2019

    Sponsors / Collaborators

    Lead Sponsor: The Hospital for Sick Children
    Responsible Party: N/A

    Location

    Toronto, Ontario, Canada

    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.

    Participant Groups

    • 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.

    • 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.

    • 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.

    • 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.

    Eligibility Criteria

    Sex: All
    Minimum Age: 3
    Maximum Age: 13
    Age Groups: Child
    Healthy Volunteers: Yes

    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

    Primary Outcomes

    • 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

    Secondary Outcomes

    • The patient will be observed for apnea after propofol is administered until the endoscopy procedure is complete. Duration of apnea will be recorded.

    • 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

    • 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)

    More Details

    NCT Number: NCT02295553
    Other IDs: 1000036780
    Study URL: https://clinicaltrials.gov/study/NCT02295553
    Last updated: Sep 29, 2023