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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02455440
Other study ID # GeorgePH
Secondary ID
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


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
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