NCT01628562

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2012

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2012

Completed
4 days until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
26 days until next milestone

First Posted

Study publicly available on registry

June 27, 2012

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

February 18, 2015

Status Verified

December 1, 2012

Enrollment Period

2.3 years

First QC Date

May 28, 2012

Last Update Submit

February 14, 2015

Conditions

TachycardiaHypertensionMyocardial Ischemia

Keywords

RemifentanilEsmololIntracranial surgeryHeart rateBlood pressure

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • the intraoperative fentanyl consumption

    during intubation, head pin insertion, extubation, early postoperative period

Study Arms (2)

GroupE/Esmolol infusion

ACTIVE COMPARATOR

Heart rate control, Beta blocker

Drug: Esmolol

GroupR/Remifentanil infusion

EXPERIMENTAL

Heart rate control, opioid

Drug: Remifentanil

Interventions

EsmololDRUG

Esmolol 50 mcg/kg/min

Also known as: Brevibloc
GroupE/Esmolol infusion
RemifentanilDRUG

Remifentanil 0.5 mcg/kg/min

Also known as: Ultiva
GroupR/Remifentanil infusion

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Intracranial surgery

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Diskapi Yildirim Beyazit Teaching and Research Hospital

Ankara, Turkey, 06610, Turkey (Türkiye)

Location

Diskapi Yildirim Beyazit Teaching and Research Hospital

Ankara, 06610, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 15618785BACKGROUND

  • 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.

    PMID: 19800816BACKGROUND

MeSH Terms

Conditions

TachycardiaHypertensionMyocardial Ischemia

Interventions

esmololRemifentanil

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and SymptomsVascular Diseases

Intervention Hierarchy (Ancestors)

PropionatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Dilek Yazicioglu

    MD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

May 28, 2012

First Posted

June 27, 2012

Study Start

June 1, 2012

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

February 18, 2015

Record last verified: 2012-12

Locations

TU(2)