Influence of Esmolol on a Closed-Loop Anesthesia System

Phase 3

Terminated

• Conditions: Anesthesia
• Interventions: Drug: NaCl 9/00; Drug: Esmolol

• Registration Number: NCT00922467
• Lead Sponsor: Hopital Foch

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-02
• Study First Submitted QC: 2009-06-16
• Study First Posted: 2009-06-17
• Primary Completion: 2009-12
• Study Completion: 2011-12
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-22
• Last Update Posted: 2016-09-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	NaCl 9/00	patients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and a placebo
Esmolol	Esmolol	patients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and esmolol

Primary Outcome Measures

Name	Time	Method
administered doses of propofol and of remifentanil during anesthesia	end of anesthesia

Secondary Outcome Measures

Name	Time	Method
hemodynamic abnormalities requiring a treatment	end of anesthesia
delay before recovery	at the end of anesthesia
postoperative morphine requirement	Third post-anesthetic hour
explicit memorisation	Second postoperative day

Trial Locations

Locations (1)

Hôpital Foch; 🇫🇷 Suresnes, France