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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01628562

Enrollment

Registered

2012-06-27

Start date

2012-06-30

Completion date

2014-09-30

Last updated

2015-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Myocardial Ischemia, Tachycardia

Keywords

Remifentanil, Esmolol, Intracranial surgery, Heart rate, Blood pressure

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.

Interventions

DRUGEsmolol

Esmolol 50 mcg/kg/min

DRUGRemifentanil

Remifentanil 0.5 mcg/kg/min

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

19 Years to 80 Years

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.

Design outcomes

Primary

Measure	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

Measure	Time frame
the intraoperative fentanyl consumption	during intubation, head pin insertion, extubation, early postoperative period

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026