Esmolol Versus Dexmedetomidine During Intracranial Procedures

Phase 3

• Conditions: Intracranial Neoplasms; Intracranial Aneurysm
• Interventions: Drug: Esmolol; Drug: Dexmedetomidine

• Registration Number: NCT02563288
• Lead Sponsor: George Papanicolaou Hospital

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).

Study Timeline

• Study First Submitted: 2015-09-19
• Study First Submitted QC: 2015-09-28
• Study First Posted: 2015-09-30
• Study Start: 2016-08
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-25
• Last Update Posted: 2017-07-27
• Primary Completion: 2017-08
• Study Completion: 2017-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Esmolol	Esmolol	Esmolol 500mcg/kg before induction in anesthesia following by 300mcg/Kg/min until extubation.
Dexmedetomidine	Dexmedetomidine	Dexmedetomidine 1mcg/Kg following by 0.7mcg/Kg/h until end of surgery.

Primary Outcome Measures

Name	Time	Method
Systolic arterial pressure- mean arterial pressure (mmHg)	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

Trial Locations

Locations (1)

George Papanikolaou General Hospital; 🇬🇷 Thessaloniki, Greece