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Esmolol Versus Dexmedetomidine During Intracranial Procedures

Primary Purpose

Intracranial Aneurysm, Intracranial Neoplasms

Status

Unknown status

Phase

Phase 3

Locations

Greece

Study Type

Interventional

Intervention

Esmolol

Dexmedetomidine

About this trial

This is an interventional treatment trial for Intracranial Aneurysm focused on measuring esmolol, dexmedetomidine, opioids

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

George Papanikolaou General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Esmolol

Dexmedetomidine

Arm Description

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

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

Outcomes

Primary Outcome Measures

Systolic arterial pressure- mean arterial pressure (mmHg)

Status of patients during emerge from anaesthesia after intracranial surgery

Secondary Outcome Measures

Full Information

NCT ID

NCT02563288

First Posted

September 19, 2015

Last Updated

July 25, 2017

Sponsor

George Papanicolaou Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02563288

Brief Title

Esmolol Versus Dexmedetomidine During Intracranial Procedures

Official Title

Comparison of Esmolol and Dexmedetomidine on Sympathetic Control During Intracranial Procedures

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Unknown status

Study Start Date

August 2016 (undefined)

Primary Completion Date

August 2017 (Anticipated)

Study Completion Date

October 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

George Papanicolaou Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Intracranial Aneurysm, Intracranial Neoplasms

Keywords

esmolol, dexmedetomidine, opioids

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Esmolol

Arm Type

Active Comparator

Arm Description

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

Arm Title

Dexmedetomidine

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Esmolol

Other Intervention Name(s)

b adrenergic antagonist

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Dexmedetomidine

Other Intervention Name(s)

alpha adrenergic agonist

Intervention Description

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

Primary Outcome Measure Information:

Title

Systolic arterial pressure- mean arterial pressure (mmHg)

Description

Status of patients during emerge from anaesthesia after intracranial surgery

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Irene Asouhidou, MD, PhD

iasouh@aol.com

First Name & Middle Initial & Last Name or Official Title & Degree

Dimitris Zosimidis, MD

d.zosimidis@gmail.com

Facility Information:

Facility Name

George Papanikolaou General Hospital

City

Thessaloniki

ZIP/Postal Code

55133

Country

Greece

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Irene Asouhidou, MD, PhD

Phone

00302310452560

iasouh@aol.com

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

16914460

Citation

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. Erratum In: Br J Anaesth. 2006 Dec;97(6):908.

Results Reference

result

PubMed Identifier

12651674

Citation

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.

Results Reference

result

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Esmolol Versus Dexmedetomidine During Intracranial Procedures

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