Esmolol Infusion in Patients Undergoing Craniotomy

General Hospital of Thessaloniki "George Papanikolaou"

Status and phase: Completed; Phase 3

Conditions: Cerebral Arterial Disease; Cerebral Aneurysm

Treatments: Drug: Esmolol; Drug: Propofol and sevoflurane; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02455440

GeorgePH

Details and patient eligibility

About

Anesthesia techniques that minimize anesthetic requirements and their effects may be beneficial. Esmolol, a short acting hyperselective β-adrenergic blocker is effective in blunting adrenergic response to several perioperative stimuli and so it might interfere in the effect of the anesthetic drugs on the brain. This study was designed to investigate the effect of esmolol on the consumption of propofol and sevoflurane in patients undergoing craniotomy.

Full description

Patients undergoing elective craniotomy for aneurysm clipping or tumor dissection were randomly divided in two groups (four subgroups). Anesthesia was induced with propofol, fentanyl and a single dose of cis-atracurium, followed by continuous infusion of remifentanil and either propofol or sevoflurane. Patients in the esmolol group received 500 mcg/kg of esmolol bolus 10 min before induction of anesthesia, followed by additional 200 mcg/kg/min of esmolol. Monitoring of the depth of anesthesia was also performed using the Bispectral Index-BIS. It was also performed monitoring of the cardiac output in order to evaluate the effect of esmolol on cardiac output.

The inspired concentration of sevoflurane and the infusion rate of propofol were adjusted in order to maintain a BIS value between 40-50.

Intraoperative emergence was detected by the elevation of BIS value, HR or MAP.

It was recorded intraoperative fluctuations of propofol and sevoflurane in both groups. Data were expressed as mean ± SD. Differences in categorical data were evaluated using the student t test.

Enrollment: 50 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with ASA physical status 1-3
• Glasgow Coma Scale:15

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,
• chronic use of b-blocker,
• Glasgow Coma Scale (GCS) <15,
• history of drug abuse,
• severe mental impairment,
• preoperative aphasia,
• neurologic deficit or preoperatively foreseen delayed extubation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

50 participants in 2 patient groups, including a placebo group

Esmolol

Active Comparator group

Description:

500 mcg/kg of esmolol bolus 10 min before induction of anesthesia, followed by additional 200 mcg/kg/min of esmolol until 30 minutes after extubation.

Treatment:

Drug: Propofol and sevoflurane

Drug: Esmolol

control

Placebo Comparator group

Description:

Control group did not receive esmolol or other b-blocker in the perioperative period.

Treatment:

Drug: Placebo