A Comparison of the Perioperative Hemodynamic Effects of Remifentanil and Esmolol in Intracranial Surgery

Study Overview
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Brief Summary
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It was hypothesized that the use of esmolol as an alternative to remifentanil with sevoflurane inhalation anesthesia during intracranial surgery, could provide better hemodynamic conditions and cause lesser side effects in the perioperative period. It was the main objective of this study to compare the effect of esmolol and remifentanil on the incidence of tachycardia and hypertension and the intraoperative fentanyl consumption. The comparison of postoperative troponine I and creatine phosphokinase levels and EKG changes were the secondary objectives.

Detailed Description
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During neurosurgical procedures intubation, insertion of the head pins, extubation and the early postoperative period are the time lines in which cerebral autoregulation can be impaired by changes in heart rate and blood pressure. Several anesthetic regimens have been implied to overcome this problem. Remifentanil is used in neurosurgery since it allows early recovery and neurologic evaluation. Esmolol on the other hand is also very short acting, effective to blunt cardiovascular responses during surgery and has no significant effect on intracranial pressure and cerebral blood flow. In addition esmolol is addressed to reduce perioperative ischemia during noncardiac surgery. It was hypothesized that the use of esmolol as an alternative to remifentanil with sevoflurane inhalation anesthesia during intracranial surgery, could provide better hemodynamic conditions and cause lesser side effects in the perioperative period. It was the main objective of this study to compare the effect of esmolol and remifentanil on the incidence of tachycardia and hypertension and the intraoperative fentanyl consumption. The comparison of postoperative troponine I and creatine phosphokinase levels and EKG changes were the secondary objectives.

Official Title
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A Comparison of the Perioperative Hemodynamic Effects of Remifentanil and Esmolol: a Double Blind Randomized Controlled Study

Conditions
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Tachycardia, Hypertension, Myocardial Ischemia

Intervention / Treatment
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* Drug: Esmolol
* Drug: Remifentanil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Intracranial surgery Exclusion Criteria: heart rate ≤ 50, atrioventricular block, sick sinus syndrome, heart failure, history of asthma, hypertension, impaired renal or hepatic function, patients receiving beta blockers or calcium channel blockers, emergency surgery.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: GroupE/Esmolol infusion<br>Heart rate control, Beta blocker | Drug: Esmolol<br>* Esmolol 50 mcg/kg/min<br>* Other names: Brevibloc;|
| Experimental: GroupR/Remifentanil infusion<br>Heart rate control, opioid | Drug: Remifentanil<br>* Remifentanil 0.5 mcg/kg/min<br>* Other names: Ultiva;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| It is the main objective of this study to compare the effect of esmolol and remifentanil on the incidence of tachycardia and hypertension |  | during intubation, head pin insertion, extubation, early postoperative period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the intraoperative fentanyl consumption |  | during intubation, head pin insertion, extubation, early postoperative period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Remifentanil, Esmolol, Intracranial surgery, Heart rate, Blood pressure