A Comparison of the Perioperative Hemodynamic Effects of... | NCT01628562

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

NCT01628562

Sponsor

Diskapi Teaching and Research Hospital

Status

Completed

Last Update Posted

Feb 18, 2015Estimated

Enrollment

40Actual

Phase

Phase 4

Conditions

Tachycardia
Hypertension
Myocardial Ischemia

Interventions

Esmolol
Remifentanil

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2012

Primary Completion Date

Sep 2014Actual

Completion Date

Sep 2014Actual

First Submitted Date

May 28, 2012

First Submission Date that Met QC Criteria

Jun 26, 2012

First Posted Date

Jun 27, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 14, 2015

Last Update Posted Date

Feb 18, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

DILEK YAZICIOGLU, Doctor, Diskapi Teaching and Research HospitalPrincipal Investigator

Lead Sponsor

Diskapi Teaching and Research HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GroupE/Esmolol infusion	Active Comparator	Heart rate control, Beta blocker	Drug: Esmolol
GroupR/Remifentanil infusion	Experimental	Heart rate control, opioid	Drug: Remifentanil

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Esmolol	Drug	Esmolol 50 mcg/kg/min	GroupE/Esmolol infusion	Brevibloc

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
It is the main objective of this study to compare the effect of esmolol and remifentanil on the incidence of tachycardia and hypertension		during intubation, head pin insertion, extubation, early postoperative period

Secondary Outcomes

Measure	Description	Time Frame
the intraoperative fentanyl consumption		during intubation, head pin insertion, extubation, early postoperative period

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dilek Yazicioglu	MD	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Diskapi Yildirim Beyazit Teaching and Research Hospital		Ankara	Turkey	06610	Turkey (Türkiye)
Diskapi Yildirim Beyazit Teaching and Research Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15618785	Background	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.
19800816	Background

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D000075224	Cardiac Conduction System Disease

ID	Term
D011422	Propionates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

ID	Term
D013610	Tachycardia
D006973	Hypertension
D017202	Myocardial Ischemia