Influence of Muscle Relaxation on a Closed-loop Anesthesia System (Drone-Curare)

Hopital Foch

Status and phase: Completed; Phase 3

Conditions: Anesthesia, General

Treatments: Drug: muscle relaxant; Drug: normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT00886418

2008/28

Details and patient eligibility

About

Total intra-venous anesthesia can be provided using a closed-loop system guided by the bispectral index. The purpose of this study is to determine if myorelaxation modifies its functioning.

Enrollment: 140 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients scheduled for a surgical procedure which not require a myorelaxation

Exclusion criteria

• age less than 18 years,
• ASA III and above,
• pregnant woman
• combined general and regional anesthesia,
• history of prolonged myorelaxation due to a decrease in cholinesterase,
• patient with a known lack in cholinesterase,
• history of cerebral or psychiatric central,
• allergy to latex, propofol, remifentanil, morphine, muscle relaxant or any of the excipients,
• known hypersensitivity to remifentanil or to an other derivative of fentanyl,
• presence of a pacemaker,
• psychotropic or agonist-antagonist morphine treatment,
• planned post-operative sedation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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140 participants in 2 patient groups

1

Active Comparator group

Description:

Total intravenous anesthesia (propofol and remifentanil) is provided using the close-loop system. A muscle relaxant is used to facilitate tracheal intubation; its administration is continued throughout anesthesia.

Treatment:

Drug: muscle relaxant

2

Experimental group

Description:

Total intravenous anesthesia (propofol and remifentanil) is provided using the close-loop system. No muscle relaxant is used and a placebo is infused throughout anesthesia.

Treatment:

Drug: normal saline