Ketamine and Closed-Loop Anesthesia System (LoopKeta)

Hopital Foch

Status and phase: Terminated; Phase 3

Conditions: Anesthesia

Treatments: Drug: Ketamine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02011347

2012/26

2012-003001-97 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 67 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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67 participants in 2 patient groups

Ketamine

Experimental group

Description:

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)

Treatment:

Drug: Ketamine

Placebo

Experimental group

Description:

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)

Treatment:

Drug: Placebo