Esmolol Versus Dexmedetomidine During Intracranial Procedures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2017-10-31

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Intracranial Aneurysm Intracranial Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Esmolol

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

Group Type ACTIVE_COMPARATOR

Esmolol

Intervention Type DRUG

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

Dexmedetomidine

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

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

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

Interventions

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Esmolol

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

Intervention Type DRUG

Dexmedetomidine

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

Intervention Type DRUG

Other Intervention Names

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b adrenergic antagonist alpha adrenergic agonist

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No