Esmolol Infusion in Patients Undergoing Craniotomy

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Brief Title

Esmolol Infusion in Patients Undergoing Craniotomy

Official Title

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

Brief 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.
    

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.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

systolic arterial pressure fluctuation

Secondary Outcome

 extubation time

Condition

Cerebral Arterial Disease

Intervention

Esmolol

Study Arms / Comparison Groups

 Esmolol
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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

50

Start Date

March 2014

Completion Date

July 2015

Primary Completion Date

July 2015

Eligibility Criteria

        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

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

Greece

Location Countries

Greece

Administrative Informations


NCT ID

NCT02455440

Organization ID

GeorgePH


Responsible Party

Principal Investigator

Study Sponsor

George Papanicolaou Hospital


Study Sponsor

, , 


Verification Date

July 2015