Ketamine and Propofol for Upper Endoscopy

NCT ID: NCT02295553

Last Updated: 2019-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2016-12-31

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.

Conditions

Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Propofol

Intervention Type: DRUG

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.

Group Type: EXPERIMENTAL

Ketamine

Intervention Type: DRUG

Propofol

Intervention Type: DRUG

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.

Group Type: EXPERIMENTAL

Ketamine

Intervention Type: DRUG

Propofol

Intervention Type: DRUG

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.

Group Type: EXPERIMENTAL

Ketamine

Intervention Type: DRUG

Propofol

Intervention Type: DRUG

Interventions

Ketamine

Intervention Type: DRUG

Propofol

Intervention Type: DRUG

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Jason Hayes

Staff Anaesthesiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jason Hayes

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Locations

The Hospital for Sick Children

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 30032885 (View on PubMed)

Other Identifiers

1000036780

Identifier Type: -

Identifier Source: org_study_id