Influence of Esmolol on a Closed-Loop Anesthesia System

Anesthesia Clinical Trial

Official title:

Closed-loop Delivery of Propofol and Remifentanil: Sparing Effect of Esmolol

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00922467
• Other study ID #: 2008/47
• Status: Terminated
• Phase: Phase 3
• First received: June 2, 2009
• Last updated: September 22, 2016
• Start date: June 2009
• Est. completion date: December 2011

Study information

• Verified date: September 2016
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: December 2011
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• NaCl 9/00
Same volume as in the esmolol group
• Esmolol
1 mg/kg administrated over 10 minutes followed by an infusion of 0,2 mg/kg/hr during all the anesthetic period

Locations

Country	Name	City	State
France	Hôpital Foch	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	administered doses of propofol and of remifentanil during anesthesia		end of anesthesia	No
Secondary	delay before recovery		at the end of anesthesia	No
Secondary	hemodynamic abnormalities requiring a treatment		end of anesthesia	No
Secondary	postoperative morphine requirement		Third post-anesthetic hour	No
Secondary	explicit memorisation		Second postoperative day	No