Esmolol Versus Dexmedetomidine During Intracranial Procedures

July 25, 2017 updated by: Asouhidou Irene, George Papanicolaou Hospital

Comparison of Esmolol and Dexmedetomidine on Sympathetic Control During Intracranial Procedures

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients scheduled for elective craniotomy are randomized to receive Dex 1γ/Kg over 10 minutes following by continuous infusion of Dex 0.7γ/Kg (group D) or esmolol 500mcg/Kg over 5 min following by continuous infusion of 300mcg/Kg/min (group E). Patients in both groups are subjected to a standardized anesthesia comprising of induction with propofol, fentanyl, rocuronium, and maintained with Oxygen-air: 1/1, sevoflurane and bolus fentanyl in order to access the same level of anesthesia (BIS 40-50). The hemodynamic variables at various stages of surgery (HR-heart rate, MAP-Mean arterial pressure) and recovery characteristics are also recorded. It is also performed monitoring of cerebral oximetry (INVOS).

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Greece
      • Thessaloniki, Greece, 55133
        • Recruiting
        • George Papanikolaou General Hospital
        • Contact:
          • Irene Asouhidou, MD, PhD
          • Phone Number: 00302310452560
          • Email: iasouh@aol.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with ASA physical status 1-3
  • Glasgow Coma Scale:13-15
  • Hunt-Hess: 0-3

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Esmolol
Esmolol 500mcg/kg before induction in anesthesia following by 300mcg/Kg/min until extubation.
Drug: Esmolol
effect of esmolol on intraoperative sympathetic control and on extubation conditions.
Other Names:
  • b adrenergic antagonist
Active Comparator: Dexmedetomidine
Dexmedetomidine 1mcg/Kg following by 0.7mcg/Kg/h until end of surgery.
Drug: Dexmedetomidine
effect of dexmedetomidine on intraoperative sympathetic control and on extubation conditions.
Other Names:
  • alpha adrenergic agonist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systolic arterial pressure- mean arterial pressure (mmHg)
Time Frame: every 15minutes, starting from the induction in anesthesia through surgery completion and up to first 24 postoperative hours.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

George Papanicolaou Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Anticipated)

August 1, 2017

Study Completion (Anticipated)

October 1, 2017

Study Registration Dates

First Submitted

September 19, 2015

First Submitted That Met QC Criteria

September 28, 2015

First Posted (Estimate)

September 30, 2015

Study Record Updates

Last Update Posted (Actual)

July 27, 2017

Last Update Submitted That Met QC Criteria

July 25, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GeorgePapanikolaouHospital

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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