Influence of Esmolol on a Closed-Loop Anesthesia System

NCT00922467 | Terminated Phase 3

• 1 other identifier: 2008/47
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• administered doses of propofol and of remifentanil during anesthesia

  end of anesthesia

Secondary Outcomes (4)

• delay before recovery

  at the end of anesthesia

• hemodynamic abnormalities requiring a treatment

  end of anesthesia

• postoperative morphine requirement

  Third post-anesthetic hour

• explicit memorisation

  Second postoperative day

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: NaCl 9/00

Esmolol

EXPERIMENTAL

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

Drug: Esmolol

Interventions

NaCl 9/00 DRUG

Same volume as in the esmolol group

Placebo

Esmolol DRUG

1 mg/kg administrated over 10 minutes followed by an infusion of 0,2 mg/kg/hr during all the anesthetic period

Esmolol

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• male patients scheduled for a general anesthesia

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hopital Foch: lead

Study Sites (1)

Hôpital Foch

Suresnes, 92151, France

Location

MeSH Terms

Interventions

esmolol

Study Officials

• Marc Fischler, MD

  Hôpital Foch

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2009
• First Posted: June 17, 2009
• Study Start: June 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2011
• Last Updated: September 23, 2016

Record last verified: 2016-09

Locations

FR (1)