Influence of Esmolol on a Closed-Loop Anesthesia System

Hopital Foch

Status and phase: Terminated; Phase 3

Conditions: Anesthesia

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00922467

2008/47

Details and patient eligibility

About

Main objective is to evaluate the sparing effect of esmolol on the required doses of propofol and remifentanil

Enrollment: 15 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,
• any other history of anaphylactic reaction,
• hypersensibility to sufentanil, or to remifentanil, or to other derivate of fentanyl,
• hypersensibility to esmolol or to an excipient,
• history of central nervous system disease,
• patients receiving a psychotropic treatment or an agonist-antagonist opiate,
• hypovolemic patients,
• patients receiving a cardio-vascular treatment,
• patients with a pacemaker,
• expected bleeding more than 20% of the blood volume,
• simultaneous general and loco-regional anesthesia,
• patients suffering from asthma, COPD, trouble of the heart rhythm or conduction, cardiac insufficiency, cardiogenogenic shock, Prinzmetal syndrome, pheochromocytoma,
• patients with a heart rate less than 50/min and/or an arterial hypotension,
• neurosurgical act or any other which precludes an adequate positioning of the bispectral electrode.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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15 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

Esmolol

Experimental group

Description:

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

Treatment:

Drug: Esmolol