Ketamine and Closed-Loop Anesthesia System

Phase 3

Terminated

• Conditions: Anesthesia
• Interventions: Drug: Ketamine; Drug: Placebo

• Registration Number: NCT02011347
• Lead Sponsor: Hopital Foch

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-12-03
• Study First Submitted QC: 2013-12-10
• Study First Posted: 2013-12-13
• Primary Completion: 2015-10-07
• Study Completion: 2015-10-07
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-05
• Last Update Posted: 2017-04-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 67

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketamine	Ketamine	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)
Placebo	Placebo	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)

Primary Outcome Measures

Name	Time	Method
administered dose of propofol during maintenance of anesthesia	day 1

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Clinique Fontaine les Dijons; 🇫🇷 Fontaine les Dijon, France

Hopital Foch; 🇫🇷 Suresnes, Hauts de Seine, France