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Completed

NCT Number: NCT02295553

Ketamine and Propofol for Upper Endoscopy

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

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Key information

Conditions

Anesthesia

Age range

3 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ketamine

Drug

Propofol

Drug

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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

  3. 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)

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

Co-administration of Ketamine and Propofol for Upper Endoscopy in Children: a Dose-finding Study

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Nov 20, 2014
Registry last updated
Jun 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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