NCT02563288

Brief Summary

Patients undergoing intracranial procedures may experience severe hypertension and tachycardia due to intracranial hypertension and to increased release of adrenaline. Preventing perioperative sympathetic activity is of great importance. A common technique is using b-blockers like esmolol, which effectively block perioperative hemodynamic changes during intracranial surgery. A2 agonists, like Dexmedetomidine-Dex are now being used as a component of a balanced anesthesia during neurosurgical procedures. This study aimed to evaluate whether esmolol or dex attenuates perioperative changes in patients undergoing elective craniotomy with fast track neuroanesthesia.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2016

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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

September 19, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 30, 2015

Completed
10 months until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

July 27, 2017

Status Verified

July 1, 2017

Enrollment Period

1 year

First QC Date

September 19, 2015

Last Update Submit

July 25, 2017

Conditions

Intracranial AneurysmIntracranial Neoplasms

Keywords

esmololdexmedetomidineopioids

Outcome Measures

Primary Outcomes (1)

  • Systolic arterial pressure- mean arterial pressure (mmHg)

    Status of patients during emerge from anaesthesia after intracranial surgery

    every 15minutes, starting from the induction in anesthesia through surgery completion and up to first 24 postoperative hours.

Study Arms (2)

Esmolol

ACTIVE COMPARATOR

Esmolol 500mcg/kg before induction in anesthesia following by 300mcg/Kg/min until extubation.

Drug: Esmolol

Dexmedetomidine

ACTIVE COMPARATOR

Dexmedetomidine 1mcg/Kg following by 0.7mcg/Kg/h until end of surgery.

Drug: Dexmedetomidine

Interventions

EsmololDRUG

effect of esmolol on intraoperative sympathetic control and on extubation conditions.

Also known as: b adrenergic antagonist
Esmolol
DexmedetomidineDRUG

effect of dexmedetomidine on intraoperative sympathetic control and on extubation conditions.

Also known as: alpha adrenergic agonist
Dexmedetomidine

Eligibility Criteria

Age18 Years - 80 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:13-15
  • Hunt-Hess: 0-3

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,
  • Glasgow Coma Scale (GCS) \<13,
  • history of drug abuse,
  • neurologic deficit or preoperatively foreseen delayed extubation,
  • preoperative heart rate\<45.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

George Papanikolaou General Hospital

Thessaloniki, 55133, Greece

RECRUITING

Related Publications (2)

  • Tanskanen PE, Kytta JV, Randell TT, Aantaa RE. Dexmedetomidine as an anaesthetic adjuvant in patients undergoing intracranial tumour surgery: a double-blind, randomized and placebo-controlled study. Br J Anaesth. 2006 Nov;97(5):658-65. doi: 10.1093/bja/ael220. Epub 2006 Aug 16.

    PMID: 16914460RESULT

  • 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: 12651674RESULT

MeSH Terms

Conditions

Intracranial AneurysmBrain Neoplasms

Interventions

esmololDexmedetomidineAdrenergic alpha-Agonists

Condition Hierarchy (Ancestors)

Intracranial Arterial DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAneurysmVascular DiseasesCardiovascular DiseasesCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAdrenergic AgonistsAdrenergic AgentsNeurotransmitter AgentsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesPhysiological Effects of Drugs

Central Study Contacts

Irene Asouhidou, MD, PhD

CONTACT

iasouh@aol.com

Dimitris Zosimidis, MD

CONTACT

d.zosimidis@gmail.com

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
Consultant anesthesiologist

Study Record Dates

First Submitted

September 19, 2015

First Posted

September 30, 2015

Study Start

August 1, 2016

Primary Completion

August 1, 2017

Study Completion

October 1, 2017

Last Updated

July 27, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)