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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

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.

Condition or disease Intervention/treatment Phase
Cerebral Arterial Disease Cerebral Aneurysm Drug: Esmolol Drug: Placebo Drug: Propofol and sevoflurane Phase 3

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 : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Esmolol Reduces Anesthetic Requirements Thereby Facilitating Early Extubation; a Prospective Controlled Study in Patients Undergoing Intracranial Surgery
Study Start Date : March 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015


Arm Intervention/treatment
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.
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: Propofol and sevoflurane
Placebo Comparator: control
Control group did not receive esmolol or other b-blocker in the perioperative period.
Drug: Placebo



Primary Outcome Measures :
  1. systolic arterial pressure fluctuation [ Time Frame: intraoperative ]

Secondary Outcome Measures :
  1. extubation time [ Time Frame: at time of surgery ]
  2. Heart rate [ Time Frame: intraoperative ]
  3. effect of esmolol on anesthetic's concentration [ Time Frame: intraoperative ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02455440


Locations
Greece
George Papanikolaou General Hospital
Thessaloniki, Greece, 55133
Sponsors and Collaborators
George Papanicolaou Hospital

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Asouhidou Irene, Dr.Irene Asouhidou, George Papanicolaou Hospital
ClinicalTrials.gov Identifier: NCT02455440     History of Changes
Other Study ID Numbers: GeorgePH
First Posted: May 27, 2015    Key Record Dates
Last Update Posted: July 8, 2015
Last Verified: July 2015

Keywords provided by Asouhidou Irene, George Papanicolaou Hospital:
esmolol
anesthetics

Additional relevant MeSH terms:
Aneurysm
Intracranial Aneurysm
Cerebral Arterial Diseases
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Propofol
Anesthetics
Sevoflurane
Esmolol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action