NCT02563288

Esmolol Versus Dexmedetomidine During Intracranial Procedures

Comparison of Esmolol and Dexmedetomidine on Sympathetic Control During Intracranial Procedures

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: George Papanicolaou Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Intracranial Aneurysm
• Intracranial Neoplasms

Interventions

Type	Name	Description
DRUG	Esmolol	effect of esmolol on intraoperative sympathetic control and on extubation conditions.
DRUG	Dexmedetomidine	effect of dexmedetomidine on intraoperative sympathetic control and on extubation conditions.

Timeline

• Start date: 2016-08-01
• Primary completion: 2017-08-01
• Completion: 2017-10-01
• First posted: 2015-09-30
• Last updated: 2017-07-27

Locations

1 site across 1 country: Greece