Influence of Dexmedetomidine on a Closed-Loop Anesthesia System

Hopital Foch

Status and phase: Completed; Phase 3

Conditions: Anesthesia

Treatments: Drug: NaCl 9/00; Drug: dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT00921284

2008/41

Details and patient eligibility

About

The main objective if to evaluate the sparing effect of dexmedetomidine on the doses of propofol and remifentanil.

Enrollment: 66 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• male patients scheduled for a general anesthesia

Exclusion criteria

• age lower than 18 years
• allergy to propofol, or to soja or to peanuts, or to sufentanil, to remifentanil, or to morphine,or to a myorelaxant or to an excipient,
• hypersensibility to sufentanil, or to remifentanil, or to other derivate of fentanyl,
• history of central nervous system disease,
• patients receiving a psychotropic treatment or an agonist-antagonist opiate,
• hypovolemic patients,
• patients receiving a cardio-vascular treatment,
• expected bleeding surgical procedure,
• simultaneous general and loco-regional anesthesia,
• severe hepatic insufficiency.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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66 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

patients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and a placebo

Treatment:

Drug: NaCl 9/00

dexmedetomidine

Experimental group

Description:

patients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and dexmedetomidine

Treatment:

Drug: dexmedetomidine