Ketamine and Propofol for Upper Endoscopy

NCT02295553 | Completed Phase 4 Results

• 1 other identifier: 1000036780
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anesthesia

Keywords

Ketamine; Propofol; Children; Pediatrics; Upper endoscopy

Outcome Measures

Primary Outcomes (1)

• Dose of Propofol Required to Prevent Movement (Response) to Insertion of Endoscope Into the Patient's 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

  This outcome is measured at the time of insertion of the endoscope into the esophagus.

Secondary Outcomes (3)

• Duration of Apnea After Propofol Administration

  This outcome will be measured after propofol is administered until the end of the procedure.

• Incidence of Adverse Respiratory Events During the Procedure

  From induction of anesthesia until endoscopy procedure is complete

• Incidence of Side Effects and Complications During the Recovery Period

  From the time procedure is complete until discharge from hospital with an average time of 1 hour.

Study Arms (4)

Ketamine 0 mg/kg

EXPERIMENTAL

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.

Drug: Propofol

Ketamine 0.25 mg/kg

EXPERIMENTAL

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.

Drug: Ketamine; Drug: Propofol

Ketamine 0.5 mg/kg

EXPERIMENTAL

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.

Drug: Ketamine; Drug: Propofol

Ketamine 1.0 mg/kg

EXPERIMENTAL

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.

Drug: Ketamine; Drug: Propofol

Interventions

Ketamine DRUG

Ketamine 0.25 mg/kg; Ketamine 0.5 mg/kg; Ketamine 1.0 mg/kg

Propofol DRUG

Ketamine 0 mg/kg; Ketamine 0.25 mg/kg; Ketamine 0.5 mg/kg; Ketamine 1.0 mg/kg

Eligibility Criteria

• Age: 3 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Known or possible difficult airway
• BMI \> 35
• Weight \< 10 kg
• Sedative premedication required
• Known contraindication to ketamine or propofol

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (1)

• 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.

  PMID: 30032885 DERIVED

MeSH Terms

Interventions

Ketamine; Propofol

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic

Results Point of Contact

• Title: Dr. Jason Hayes
• Organization: The Hospital for Sick Children, Toronto, Ontario, Canada

jason.hayes@sickkids.ca

416-813-7654

Study Officials

• Jason Hayes

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Anaesthesiologist

Study Record Dates

• First Submitted: December 12, 2013
• First Posted: November 20, 2014
• Study Start: July 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: June 10, 2019
• Results First Posted: June 10, 2019

Record last verified: 2019-03

Locations

CA (1)