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Esmolol Infusion in Patients Undergoing Craniotomy

Primary Purpose

Cerebral Arterial Disease, Cerebral Aneurysm

Status
Completed
Phase
Phase 3
Locations
Greece
Study Type
Interventional
Intervention
Esmolol
Placebo
Propofol and sevoflurane
Sponsored by
George Papanicolaou Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Arterial Disease focused on measuring esmolol, anesthetics

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • George Papanikolaou General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Esmolol

control

Arm 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.

Control group did not receive esmolol or other b-blocker in the perioperative period.

Outcomes

Primary Outcome Measures

systolic arterial pressure fluctuation

Secondary Outcome Measures

extubation time
Heart rate
effect of esmolol on anesthetic's concentration

Full Information

First Posted
May 9, 2015
Last Updated
July 7, 2015
Sponsor
George Papanicolaou Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02455440
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
George Papanicolaou Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Arterial Disease, Cerebral Aneurysm
Keywords
esmolol, anesthetics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Esmolol
Arm Type
Active Comparator
Arm 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.
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
Control group did not receive esmolol or other b-blocker in the perioperative period.
Intervention Type
Drug
Intervention Name(s)
Esmolol
Other Intervention Name(s)
propofol, sevoflurane
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
Propofol and sevoflurane
Primary Outcome Measure Information:
Title
systolic arterial pressure fluctuation
Time Frame
intraoperative
Secondary Outcome Measure Information:
Title
extubation time
Time Frame
at time of surgery
Title
Heart rate
Time Frame
intraoperative
Title
effect of esmolol on anesthetic's concentration
Time Frame
intraoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
George Papanikolaou General Hospital
City
Thessaloniki
ZIP/Postal Code
55133
Country
Greece

12. IPD Sharing Statement

Citations:
PubMed Identifier
14725513
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. doi: 10.1111/j.1365-2044.2004.03460.x.
Results Reference
background
PubMed Identifier
12651674
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):1145-1149. doi: 10.1213/01.ANE.0000055647.54957.77.
Results Reference
background
PubMed Identifier
18929282
Citation
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.
Results Reference
background
PubMed Identifier
26615516
Citation
Asouhidou I, Trikoupi A. Esmolol reduces anesthetic requirements thereby facilitating early extubation; a prospective controlled study in patients undergoing intracranial surgery. BMC Anesthesiol. 2015 Nov 28;15:172. doi: 10.1186/s12871-015-0154-1.
Results Reference
derived

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Esmolol Infusion in Patients Undergoing Craniotomy

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