Ketamine and Closed-Loop Anesthesia System

Phase 3TerminatedNCT02011347

Hopital Foch67 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Anesthesia

Interventions

KetamineDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (2)

Hopital Foch

Suresnes, Hauts de Seine, France

Clinique Fontaine les Dijons

Fontaine-lès-Dijon, France

Outcomes

Primary Outcomes

administered dose of propofol during maintenance of anesthesia

Time frame: day 1

Secondary Outcomes

bispectral index measurement

bispectral index modification due to ketamine infusion before induction of anesthesia

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

Data from ClinicalTrials.gov

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