NCT02455440

Brief Summary

Anesthesia techniques that minimize anesthetic requirements and their effects may be beneficial. Esmolol, a short acting hyperselective β-adrenergic blocker is effective in blunting adrenergic response to several perioperative stimuli and so it might interfere in the effect of the anesthetic drugs on the brain. This study was designed to investigate the effect of esmolol on the consumption of propofol and sevoflurane in patients undergoing craniotomy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2014

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

March 1, 2014

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2015

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 27, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

July 8, 2015

Status Verified

July 1, 2015

Enrollment Period

1.3 years

First QC Date

May 9, 2015

Last Update Submit

July 7, 2015

Conditions

Cerebral Arterial DiseaseCerebral Aneurysm

Keywords

esmololanesthetics

Outcome Measures

Primary Outcomes (1)

  • systolic arterial pressure fluctuation

    intraoperative

Secondary Outcomes (3)

  • extubation time

    at time of surgery

  • Heart rate

    intraoperative

  • effect of esmolol on anesthetic's concentration

    intraoperative

Study Arms (2)

Esmolol

ACTIVE COMPARATOR

500 mcg/kg of esmolol bolus 10 min before induction of anesthesia, followed by additional 200 mcg/kg/min of esmolol until 30 minutes after extubation.

Drug: EsmololDrug: Propofol and sevoflurane

control

PLACEBO COMPARATOR

Control group did not receive esmolol or other b-blocker in the perioperative period.

Drug: Placebo

Interventions

EsmololDRUG

effect of esmolol on intraoperative fluctuations of propofol and sevoflurane. Propofol and sevoflurane intraoperative concentration will be expressed as mean ± SD. Differences in categorical data will be evaluated using the student t test.

Also known as: propofol, sevoflurane
Esmolol
PlaceboDRUG
control
Propofol and sevofluraneDRUG
Esmolol

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with ASA physical status 1-3
  • Glasgow Coma Scale:15

You may not qualify if:

  • Patients with ASA physical status \>3,
  • Body Mass Index (BMI) over 30,
  • indication for rapid sequence induction,
  • any contraindication for receiving b-blocker,
  • chronic use of b-blocker,
  • Glasgow Coma Scale (GCS) \<15,
  • history of drug abuse,
  • severe mental impairment,
  • preoperative aphasia,
  • neurologic deficit or preoperatively foreseen delayed extubation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

George Papanikolaou General Hospital

Thessaloniki, Thessaloniki, 55133, Greece

Location

Related Publications (4)

  • Wilson ES, McKinlay S, Crawford JM, Robb HM. The influence of esmolol on the dose of propofol required for induction of anaesthesia. Anaesthesia. 2004 Feb;59(2):122-6. doi: 10.1111/j.1365-2044.2004.03460.x.

    PMID: 14725513BACKGROUND

  • Grillo P, Bruder N, Auquier P, Pellissier D, Gouin F. Esmolol blunts the cerebral blood flow velocity increase during emergence from anesthesia in neurosurgical patients. Anesth Analg. 2003 Apr;96(4):1145-1149. doi: 10.1213/01.ANE.0000055647.54957.77.

    PMID: 12651674BACKGROUND

  • Bilotta F, Lam AM, Doronzio A, Cuzzone V, Delfini R, Rosa G. Esmolol blunts postoperative hemodynamic changes after propofol-remifentanil total intravenous fast-track neuroanesthesia for intracranial surgery. J Clin Anesth. 2008 Sep;20(6):426-30. doi: 10.1016/j.jclinane.2008.04.006.

    PMID: 18929282BACKGROUND

  • Asouhidou I, Trikoupi A. Esmolol reduces anesthetic requirements thereby facilitating early extubation; a prospective controlled study in patients undergoing intracranial surgery. BMC Anesthesiol. 2015 Nov 28;15:172. doi: 10.1186/s12871-015-0154-1.

    PMID: 26615516DERIVED

MeSH Terms

Conditions

Cerebral Arterial DiseasesIntracranial Aneurysm

Interventions

esmololPropofolSevoflurane

Condition Hierarchy (Ancestors)

Intracranial Arterial DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesAneurysm

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsMethyl EthersEthersHydrocarbons, FluorinatedHydrocarbons, Halogenated

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.Irene Asouhidou

Study Record Dates

First Submitted

May 9, 2015

First Posted

May 27, 2015

Study Start

March 1, 2014

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

July 8, 2015

Record last verified: 2015-07

Locations

GR(1)