NCT01628562

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Diskapi Teaching and Research Hospital · Academic / Other
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tachycardia
• Hypertension
• Myocardial Ischemia

Interventions

Type	Name	Description
DRUG	Esmolol	Esmolol 50 mcg/kg/min
DRUG	Remifentanil	Remifentanil 0.5 mcg/kg/min

Timeline

• Start date: 2012-06-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2012-06-27
• Last updated: 2015-02-18

Locations

2 sites across 1 country: Turkey (Türkiye)