Ketamine and Closed-Loop Anesthesia System (LoopKeta)

Influence of Ketamine on a Closed-Loop Anesthesia System

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

Study Overview

• Status: Terminated
• Conditions: Anesthesia
• Intervention / Treatment: Drug: Placebo; Drug: Ketamine

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Fontaine les Dijon, France, 21121
    • Clinique Fontaine les Dijons
  • Hauts de Seine
    • Suresnes, Hauts de Seine, France, 92151
      • Hopital FOCH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Drug: Ketamine
Experimental: 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)	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
administered dose of propofol during maintenance of anesthesia	day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
bispectral index measurement	bispectral index modification due to ketamine infusion before induction of anesthesia	1 day
administered dose of propofol during induction of anesthesia		day 1
administered doses of remifentanil during induction and maintenance of anesthesia		day 1
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
postoperative morphine requirement		day 1
incidence of postoperative nausea and vomiting		day 1
White and Song score		day 1
% of patients with an explicit memorisation of the intraoperative period		second postoperative day

Collaborators and Investigators

• Sponsor: Hopital Foch

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): October 7, 2015
• Study Completion (Actual): October 7, 2015

Study Registration Dates

• First Submitted: December 3, 2013
• First Submitted That Met QC Criteria: December 10, 2013
• First Posted (Estimate): December 13, 2013

Study Record Updates

• Last Update Posted (Actual): April 6, 2017
• Last Update Submitted That Met QC Criteria: April 5, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Ketamine
• Other Study ID Numbers: 2012/26; 2012-003001-97 (EudraCT Number)