Influence of Esmolol on a Closed-Loop Anesthesia System

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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00922467

Enrollment

Registered

2009-06-17

Start date

2009-06-30

Completion date

2011-12-31

Last updated

2016-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Brief summary

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

Interventions

DRUGNaCl 9/00

Same volume as in the esmolol group

DRUGEsmolol

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
administered doses of propofol and of remifentanil during anesthesia	end of anesthesia

Secondary

Measure	Time frame
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026