A Comparison of the Perioperative Hemodynamic Effects of Remifentanil and Esmolol in Intracranial Surgery
Primary Purpose
Tachycardia, Hypertension, Myocardial Ischemia
Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Esmolol
Remifentanil
Sponsored by
About this trial
This is an interventional treatment trial for Tachycardia focused on measuring Remifentanil, Esmolol, Intracranial surgery, Heart rate, Blood pressure
Eligibility 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.
Sites / Locations
- Diskapi Yildirim Beyazit Teaching and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
GroupE/Esmolol infusion
GroupR/Remifentanil infusion
Arm Description
Heart rate control, Beta blocker
Heart rate control, opioid
Outcomes
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
Secondary Outcome Measures
the intraoperative fentanyl consumption
Full Information
NCT ID
NCT01628562
First Posted
May 28, 2012
Last Updated
February 14, 2015
Sponsor
Diskapi Teaching and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01628562
Brief Title
A Comparison of the Perioperative Hemodynamic Effects of Remifentanil and Esmolol in Intracranial Surgery
Official Title
A Comparison of the Perioperative Hemodynamic Effects of Remifentanil and Esmolol: a Double Blind Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Diskapi Teaching and Research Hospital
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tachycardia, Hypertension, Myocardial Ischemia
Keywords
Remifentanil, Esmolol, Intracranial surgery, Heart rate, Blood pressure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GroupE/Esmolol infusion
Arm Type
Active Comparator
Arm Description
Heart rate control, Beta blocker
Arm Title
GroupR/Remifentanil infusion
Arm Type
Experimental
Arm Description
Heart rate control, opioid
Intervention Type
Drug
Intervention Name(s)
Esmolol
Other Intervention Name(s)
Brevibloc
Intervention Description
Esmolol 50 mcg/kg/min
Intervention Type
Drug
Intervention Name(s)
Remifentanil
Other Intervention Name(s)
Ultiva
Intervention Description
Remifentanil 0.5 mcg/kg/min
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
the intraoperative fentanyl consumption
Time Frame
during intubation, head pin insertion, extubation, early postoperative period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dilek Yazicioglu
Organizational Affiliation
MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Diskapi Yildirim Beyazit Teaching and Research Hospital
City
Ankara
ZIP/Postal Code
06610
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
15618785
Citation
Heinke W, Zysset S, Hund-Georgiadis M, Olthoff D, von Cramon DY. The effect of esmolol on cerebral blood flow, cerebral vasoreactivity, and cognitive performance: a functional magnetic resonance imaging study. Anesthesiology. 2005 Jan;102(1):41-50. doi: 10.1097/00000542-200501000-00010.
Results Reference
background
PubMed Identifier
19800816
Citation
Landoni G, Turi S, Biondi-Zoccai G, Bignami E, Testa V, Belloni I, Cornero G, Zangrillo A. Esmolol reduces perioperative ischemia in noncardiac surgery: a meta-analysis of randomized controlled studies. J Cardiothorac Vasc Anesth. 2010 Apr;24(2):219-29. doi: 10.1053/j.jvca.2009.07.008. Epub 2009 Oct 2.
Results Reference
background
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A Comparison of the Perioperative Hemodynamic Effects of Remifentanil and Esmolol in Intracranial Surgery
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