Esmolol Infusion in Patients Undergoing Craniotomy

Study Overview
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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.

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.

Official Title
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Esmolol Reduces Anesthetic Requirements Thereby Facilitating Early Extubation; a Prospective Controlled Study in Patients Undergoing Intracranial Surgery

Conditions
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Cerebral Arterial Disease, Cerebral Aneurysm

Intervention / Treatment
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* Drug: Esmolol
* Drug: Placebo
* Drug: Propofol and sevoflurane


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Esmolol<br>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. | Drug: Esmolol<br>* 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.<br>* Other names: sevoflurane;Drug: Propofol and sevoflurane<br> <br> |
| Placebo Comparator: control<br>Control group did not receive esmolol or other b-blocker in the perioperative period. | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| systolic arterial pressure fluctuation |  | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| extubation time |  | at time of surgery | 
| Heart rate |  | intraoperative | 
| effect of esmolol on anesthetic's concentration |  | intraoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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esmolol, anesthetics