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NCT Number: NCT01628562

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

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Key information

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Diskapi Yildirim Beyazit Teaching and Research Hospital, Ankara, Turkey, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

esmolol

Drug

Esmolol 50 mcg/kg/min

Other names: Brevibloc

Remifentanil

Drug

Remifentanil 0.5 mcg/kg/min

Other names: Ultiva

Primary outcomes

  1. It is the main objective of this study to compare the effect of esmolol and remifentanil on the incidence of tachycardia and hypertension

    Time frame: during intubation, head pin insertion, extubation, early postoperative period

Secondary outcomes

  1. the intraoperative fentanyl consumption

    Time frame: during intubation, head pin insertion, extubation, early postoperative period

Sponsors and collaborators

Lead sponsor

Diskapi Teaching and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 27, 2012
Registry last updated
Feb 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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