Phase 4 N=56 Randomized Double-blind Treatment

Ketamine and Propofol for Upper Endoscopy

Anesthesia

Bottom Line

View on ClinicalTrials.gov: NCT02295553 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2019

Primary outcome: Primary: Dose of Propofol Required to Prevent Movement (Response) to Insertion of Endoscope Into the Patient's Esophagus — 6.1; 4.5; 4.7; 1.1 mg/kg

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Ketamine (Drug); Propofol (Drug)
Age: Pediatric · 3+ yrs
Sex: All
Sponsor: The Hospital for Sick Children
Primary completion: Dec 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Dose of Propofol Required to Prevent Movement (Response) to Insertion of Endoscope Into the Patient's Esophagus	6.1; 4.5; 4.7; 1.1	—
SECONDARY Duration of Apnea After Propofol Administration	59; 45; 57; 39	—
SECONDARY Incidence of Adverse Respiratory Events During the Procedure	11; 10; 11; 9; 1; 1	—
SECONDARY Incidence of Side Effects and Complications During the Recovery Period	0; 0; 1; 0; 0; 0	—

Summary

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

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02295553). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.