Overview

This trial is active, not recruiting.

Condition anesthesia
Treatments ketamine, placebo
Phase phase 3
Sponsor Hopital Foch
Start date July 2013
End date February 2016
Trial size 90 participants
Trial identifier NCT02011347, 2012-003001-97, 2012/26

Summary

The objective is to evaluate the sparing effect of ketamine on the dose of propofol.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver)
Primary purpose treatment
Arm
(Experimental)
Patients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and Ketamine (bolus dose of Ketamine (0.15 mg.kg-1) followed by an infusion of Ketamine (0.15 mg.kg-1 h-1) until the end of anesthesia)
ketamine
(Experimental)
patients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and a placebo (NaCl 9/00 (same volume as in the Ketamine group)
placebo

Primary Outcomes

Measure
administered dose of propofol during maintenance of anesthesia
time frame: day 1

Secondary Outcomes

Measure
bispectral index measurement
time frame: 1 day
administered dose of propofol during induction of anesthesia
time frame: day 1
administered doses of remifentanil during induction and maintenance of anesthesia
time frame: day 1
delay (measured as minutes) between the end of propofol and remifentanil administration and the recovery from anesthesia
time frame: day 1
hemodynamic abnormalities requiring treatment
time frame: day 1
% of time with a bispectral index between 40 and 60
time frame: day 1
postoperative morphine requirement
time frame: day 1
incidence of postoperative nausea and vomiting
time frame: day 1
White and Song score
time frame: day 1
% of patients with an explicit memorisation of the intraoperative period
time frame: second postoperative day

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - patients with an American Society of Anesthesiology score 1, 2 or 3 - scheduled for a surgical procedure lasting more than 2 hours under general anesthesia Exclusion Criteria: - pregnancy - chronic pain - simultaneous general and loco-regional anesthesia - contra-indication to to nonsteroidal anti-inflammatory drug - contra-indication to Ketamine - contra-indication to propofol, to remifentanil, to morphine - history of central nervous system disease - patients receiving a psychotropic treatment - patients with a pace-maker

Additional Information

Official title Influence of Ketamine on a Closed-Loop Anesthesia System
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Hopital Foch.