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

Diskapi Teaching and Research Hospital

Status and phase: Completed; Phase 4

Conditions: Hypertension; Myocardial Ischemia; Tachycardia

Treatments: Drug: Remifentanil; Drug: Esmolol

Study type: Interventional

Funder types: Other

Identifiers

NCT01628562

Dilek Esmolol

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

GroupE/Esmolol infusion

Active Comparator group

Description:

Heart rate control, Beta blocker

Treatment:

Drug: Esmolol

GroupR/Remifentanil infusion

Experimental group

Description:

Heart rate control, opioid

Treatment:

Drug: Remifentanil