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

Phase 4

Completed

• Conditions: Tachycardia; Hypertension; Myocardial Ischemia
• Interventions: Drug: Esmolol; Drug: Remifentanil

• Registration Number: NCT01628562
• Lead Sponsor: Diskapi Teaching and Research Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2012-05-28
• Study Start: 2012-06
• Study First Submitted QC: 2012-06-26
• Study First Posted: 2012-06-27
• Status Verified: 2012-12
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Last Update Submitted: 2015-02-14
• Last Update Posted: 2015-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GroupE/Esmolol infusion	Esmolol	Heart rate control, Beta blocker
GroupR/Remifentanil infusion	Remifentanil	Heart rate control, opioid

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
the intraoperative fentanyl consumption	during intubation, head pin insertion, extubation, early postoperative period

Trial Locations

Locations (1)

Diskapi Yildirim Beyazit Teaching and Research Hospital; 🇹🇷 Ankara, Turkey