Esmolol Infusion in Patients Undergoing Craniotomy

Overview

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 Title of Study: “Esmolol Reduces Anesthetic Requirements Thereby Facilitating Early Extubation; a Prospective Controlled Study in Patients Undergoing Intracranial Surgery”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2015

Detailed 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.

Interventions

  • Drug: Esmolol
    • effect of esmolol on intraoperative fluctuations of propofol and sevoflurane. Propofol and sevoflurane intraoperative concentration will be expressed as mean ± SD. Differences in categorical data will be evaluated using the student t test.
  • Drug: Placebo
  • Drug: Propofol and sevoflurane

Arms, Groups and Cohorts

  • Active Comparator: Esmolol
    • 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.
  • Placebo Comparator: control
    • Control group did not receive esmolol or other b-blocker in the perioperative period.

Clinical Trial Outcome Measures

Primary Measures

  • systolic arterial pressure fluctuation
    • Time Frame: intraoperative

Secondary Measures

  • extubation time
    • Time Frame: at time of surgery
  • Heart rate
    • Time Frame: intraoperative
  • effect of esmolol on anesthetic’s concentration
    • Time Frame: intraoperative

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • George Papanicolaou Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Asouhidou Irene, Dr.Irene Asouhidou – George Papanicolaou Hospital

References

Wilson ES, McKinlay S, Crawford JM, Robb HM. The influence of esmolol on the dose of propofol required for induction of anaesthesia. Anaesthesia. 2004 Feb;59(2):122-6. doi: 10.1111/j.1365-2044.2004.03460.x.

Grillo P, Bruder N, Auquier P, Pellissier D, Gouin F. Esmolol blunts the cerebral blood flow velocity increase during emergence from anesthesia in neurosurgical patients. Anesth Analg. 2003 Apr;96(4):1145-1149. doi: 10.1213/01.ANE.0000055647.54957.77.

Bilotta F, Lam AM, Doronzio A, Cuzzone V, Delfini R, Rosa G. Esmolol blunts postoperative hemodynamic changes after propofol-remifentanil total intravenous fast-track neuroanesthesia for intracranial surgery. J Clin Anesth. 2008 Sep;20(6):426-30. doi: 10.1016/j.jclinane.2008.04.006.

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