A Comparison of the Perioperative Hemodynamic Effects of Remifentanil and Esmolol in Intracranial Surgery
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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 cretine 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 |
- 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 ]
- the intraoperative fentanyl consumption [ Time Frame: during intubation, head pin insertion, extubation, early postoperative period ] [ Designated as safety issue: No ]
- The comparison of postoperative troponine I and creatine phosphokinase levels [ Time Frame: postoperative 12 th hour. ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | September 2013 (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, opiod
|
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 cretine 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 |
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| Contact: Dilek Yazicioglu, MD | +905336957855 |
| 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 | |
| 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: | December 17, 2012 |
| 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 Heart Diseases Cardiovascular Diseases Vascular Diseases Coronary Disease Arterial Occlusive Diseases Myocardial Ischemia Hypertension Ischemia Tachycardia Arteriosclerosis Pathologic Processes Arrhythmias, Cardiac Esmolol Remifentanil |
Adrenergic beta-1 Receptor Antagonists Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Analgesics, Opioid Analgesics Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants |
ClinicalTrials.gov processed this record on June 17, 2013