Esmolol Infusion in Patients Undergoing Craniotomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-07-31

Brief Summary

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Anesthesia techniques that minimize anesthetic requirements and their effects may be beneficial. Esmolol, a short acting hyperselective β-adrenergic blocker is effective in blunting adrenergic response to several perioperative stimuli and so it might interfere in the effect of the anesthetic drugs on the brain. This study was designed to investigate the effect of esmolol on the consumption of propofol and sevoflurane in patients undergoing craniotomy.

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Detailed Description

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Patients undergoing elective craniotomy for aneurysm clipping or tumor dissection were randomly divided in two groups (four subgroups). Anesthesia was induced with propofol, fentanyl and a single dose of cis-atracurium, followed by continuous infusion of remifentanil and either propofol or sevoflurane. Patients in the esmolol group received 500 mcg/kg of esmolol bolus 10 min before induction of anesthesia, followed by additional 200 mcg/kg/min of esmolol. Monitoring of the depth of anesthesia was also performed using the Bispectral Index-BIS. It was also performed monitoring of the cardiac output in order to evaluate the effect of esmolol on cardiac output.

The inspired concentration of sevoflurane and the infusion rate of propofol were adjusted in order to maintain a BIS value between 40-50.

Intraoperative emergence was detected by the elevation of BIS value, HR or MAP.

It was recorded intraoperative fluctuations of propofol and sevoflurane in both groups. Data were expressed as mean ± SD. Differences in categorical data were evaluated using the student t test.

Conditions

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Cerebral Arterial Disease Cerebral Aneurysm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Esmolol

500 mcg/kg of esmolol bolus 10 min before induction of anesthesia, followed by additional 200 mcg/kg/min of esmolol until 30 minutes after extubation.

Group Type ACTIVE_COMPARATOR

Esmolol

Intervention Type DRUG

effect of esmolol on intraoperative fluctuations of propofol and sevoflurane. Propofol and sevoflurane intraoperative concentration will be expressed as mean ± SD. Differences in categorical data will be evaluated using the student t test.

Propofol and sevoflurane

Intervention Type DRUG

control

Control group did not receive esmolol or other b-blocker in the perioperative period.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Esmolol

effect of esmolol on intraoperative fluctuations of propofol and sevoflurane. Propofol and sevoflurane intraoperative concentration will be expressed as mean ± SD. Differences in categorical data will be evaluated using the student t test.

Intervention Type DRUG

Placebo

Intervention Type DRUG

Propofol and sevoflurane

Intervention Type DRUG

Other Intervention Names

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propofol sevoflurane

Eligibility Criteria

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Inclusion Criteria

* Patients with ASA physical status 1-3
* Glasgow Coma Scale:15

Exclusion Criteria

* Patients with ASA physical status \>3,
* Body Mass Index (BMI) over 30,
* indication for rapid sequence induction,
* any contraindication for receiving b-blocker,
* chronic use of b-blocker,
* Glasgow Coma Scale (GCS) \<15,
* history of drug abuse,
* severe mental impairment,
* preoperative aphasia,
* neurologic deficit or preoperatively foreseen delayed extubation.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No