Esmolol Infusion in Patients Undergoing Craniotomy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02455440|
Recruitment Status : Completed
First Posted : May 27, 2015
Last Update Posted : July 8, 2015
|Condition or disease||Intervention/treatment||Phase|
|Cerebral Arterial Disease Cerebral Aneurysm||Drug: Esmolol Drug: Placebo Drug: Propofol and sevoflurane||Phase 3|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
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.
Drug: Propofol and sevoflurane
Placebo Comparator: control
Control group did not receive esmolol or other b-blocker in the perioperative period.
- systolic arterial pressure fluctuation [ Time Frame: intraoperative ]
- extubation time [ Time Frame: at time of surgery ]
- Heart rate [ Time Frame: intraoperative ]
- effect of esmolol on anesthetic's concentration [ Time Frame: intraoperative ]
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
|George Papanikolaou General Hospital|
|Thessaloniki, Greece, 55133|