Esmolol Versus Dexmedetomidine During Intracranial Procedures

Study Overview
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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.

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).

Official Title
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Comparison of Esmolol and Dexmedetomidine on Sympathetic Control During Intracranial Procedures

Conditions
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Intracranial Aneurysm, Intracranial Neoplasms

Intervention / Treatment
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* Drug: Esmolol
* Drug: Dexmedetomidine


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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esmolol, dexmedetomidine, opioids