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Esmolol Infusion in Patients Undergoing Craniotomy

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ClinicalTrials.gov Identifier: NCT02455440
Recruitment Status : Completed
First Posted : May 27, 2015
Last Update Posted : July 8, 2015
Sponsor:
Information provided by (Responsible Party):
Asouhidou Irene, George Papanicolaou Hospital

Tracking Information
First Submitted Date  ICMJE May 9, 2015
First Posted Date  ICMJE May 27, 2015
Last Update Posted Date July 8, 2015
Study Start Date  ICMJE March 2014
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 26, 2015)
systolic arterial pressure fluctuation [ Time Frame: intraoperative ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02455440 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 26, 2015)
  • extubation time [ Time Frame: at time of surgery ]
  • Heart rate [ Time Frame: intraoperative ]
  • effect of esmolol on anesthetic's concentration [ Time Frame: intraoperative ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Esmolol Infusion in Patients Undergoing Craniotomy
Official Title  ICMJE 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cerebral Arterial Disease
  • Cerebral Aneurysm
Intervention  ICMJE
  • 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.
    Other Names:
    • propofol
    • sevoflurane
  • Drug: Placebo
  • Drug: Propofol and sevoflurane
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Esmolol
    • Drug: Propofol and sevoflurane
  • Placebo Comparator: control
    Control group did not receive esmolol or other b-blocker in the perioperative period.
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 26, 2015)
50
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Greece
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02455440
Other Study ID Numbers  ICMJE GeorgePH
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Asouhidou Irene, George Papanicolaou Hospital
Study Sponsor  ICMJE George Papanicolaou Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account George Papanicolaou Hospital
Verification Date July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP