Esmolol Versus Dexmedetomidine During Intracranial Procedures

General Hospital of Thessaloniki "George Papanikolaou"

Status and phase: Unknown; Phase 3

Conditions: Intracranial Neoplasms; Intracranial Aneurysm

Treatments: Drug: Esmolol; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT02563288

GeorgePapanikolaouHospital

Details and patient eligibility

About

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.

Full 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).

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 2 patient groups

Esmolol

Active Comparator group

Description:

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

Treatment:

Drug: Esmolol

Dexmedetomidine

Active Comparator group

Description:

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

Treatment:

Drug: Dexmedetomidine