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

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ClinicalTrials.gov Identifier: NCT01628562
Recruitment Status : Completed
First Posted : June 27, 2012
Last Update Posted : February 18, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Tachycardia Hypertension Myocardial Ischemia Drug: Esmolol Drug: Remifentanil Phase 4

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Comparison of the Perioperative Hemodynamic Effects of Remifentanil and Esmolol: a Double Blind Randomized Controlled Study
Study Start Date : June 2012
Primary Completion Date : September 2014
Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  1. the intraoperative fentanyl consumption [ Time Frame: during intubation, head pin insertion, extubation, early postoperative period ]

Eligibility Criteria

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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01628562


Locations
Turkey
Diskapi Yildirim Beyazit Teaching and Research Hospital
Ankara, Turkey, 06610
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
First Posted: June 27, 2012    Key Record Dates
Last Update Posted: February 18, 2015
Last Verified: December 2012

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

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