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

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

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2014-09-30

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.

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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.

Conditions

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Tachycardia Hypertension Myocardial Ischemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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GroupE/Esmolol infusion

Heart rate control, Beta blocker

Group Type ACTIVE_COMPARATOR

Esmolol

Intervention Type DRUG

Esmolol 50 mcg/kg/min

GroupR/Remifentanil infusion

Heart rate control, opioid

Group Type EXPERIMENTAL

Remifentanil

Intervention Type DRUG

Remifentanil 0.5 mcg/kg/min

Interventions

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Esmolol

Esmolol 50 mcg/kg/min

Intervention Type DRUG

Remifentanil

Remifentanil 0.5 mcg/kg/min

Intervention Type DRUG

Other Intervention Names

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Brevibloc Ultiva

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.

Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No