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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Diskapi Teaching and Research Hospital
Sponsor:
Information provided by (Responsible Party):
DILEK YAZICIOGLU, Diskapi Teaching and Research Hospital
ClinicalTrials.gov Identifier:
NCT01628562
First received: May 28, 2012
Last updated: September 30, 2013
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Tachycardia
Hypertension
Myocardial Ischemia
Drug: Esmolol
Drug: Remifentanil
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Comparison of the Perioperative Hemodynamic Effects of Remifentanil and Esmolol: a Double Blind Randomized Controlled Study

Resource links provided by NLM:


Further study details as provided by Diskapi Teaching and Research Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • the intraoperative fentanyl consumption [ Time Frame: during intubation, head pin insertion, extubation, early postoperative period ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: June 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: GroupE/Esmolol infusion
Heart rate control, Beta blocker
Drug: Esmolol
Esmolol 50 mcg/kg/min
Other Name: Brevibloc
Experimental: GroupR/Remifentanil infusion
Heart rate control, opioid
Drug: Remifentanil
Remifentanil 0.5 mcg/kg/min
Other Name: Ultiva

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.

  Eligibility

Ages Eligible for Study:   19 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01628562

Contacts
Contact: Dilek Yazicioglu, MD +905336957855

Locations
Turkey
Diskapi Yildirim Beyazit Teaching and Research Hospital Not yet recruiting
Ankara, Turkey, 06610
Contact: Murat Alper, Prof    +903125962026    muratalper@hotmail.com   
Principal Investigator: Dilek Yazicioglu, MD         
Diskapi Yildirim Beyazit Teaching and Research Hospital Recruiting
Ankara, Turkey, 06610
Contact: Murat Alper, Prof    +903125962026    muratalper@hotmail.com   
Principal Investigator: Dilek Yazicioglu, M D         
Sponsors and Collaborators
Diskapi Teaching and Research Hospital
Investigators
Principal Investigator: Dilek Yazicioglu MD
  More Information

Publications:
Responsible Party: DILEK YAZICIOGLU, Doctor, Diskapi Teaching and Research Hospital
ClinicalTrials.gov Identifier: NCT01628562     History of Changes
Other Study ID Numbers: Dilek Esmolol
Study First Received: May 28, 2012
Last Updated: September 30, 2013
Health Authority: Turkey: Ministry of Health

Keywords provided by Diskapi Teaching and Research Hospital:
Remifentanil
Esmolol
Intracranial surgery
Heart rate
Blood pressure

Additional relevant MeSH terms:
Coronary Artery Disease
Hypertension
Myocardial Ischemia
Tachycardia
Arrhythmias, Cardiac
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Pathologic Processes
Vascular Diseases
Esmolol
Remifentanil
Adrenergic Agents
Adrenergic Antagonists
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Analgesics
Analgesics, Opioid
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Narcotics
Neurotransmitter Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on October 29, 2014