Esmolol Infusion in Patients Undergoing Craniotomy

Cerebral Aneurysm Clinical Trial

Official title:

Esmolol Reduces Anesthetic Requirements Thereby Facilitating Early Extubation; a Prospective Controlled Study in Patients Undergoing Intracranial Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02455440
• Other study ID #: GeorgePH
• Status: Completed
• Phase: Phase 3
• First received: May 9, 2015
• Last updated: July 7, 2015
• Start date: March 2014
• Est. completion date: July 2015

Study information

• Verified date: July 2015
• Source: George Papanicolaou Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Hellenic Data Protection Authority
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Aneurysm
• Cerebral Arterial Disease
• Cerebral Arterial Diseases
• Intracranial Aneurysm

Intervention

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.
• Placebo

• Propofol and sevoflurane

Locations

Country	Name	City	State
Greece	George Papanikolaou General Hospital	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
George Papanicolaou Hospital

Country where clinical trial is conducted

Greece, 

References & Publications (3)

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. — View Citation

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):1145-9, table of contents. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	systolic arterial pressure fluctuation		intraoperative	Yes
Secondary	extubation time		at time of surgery	Yes
Secondary	Heart rate		intraoperative	Yes
Secondary	effect of esmolol on anesthetic's concentration		intraoperative	Yes