Glasgow Coma Scales and General Anesthesia

Not Applicable

Completed

• Conditions: Anesthesia Awareness
• Interventions: Device: Bispectral index (BIS) monitoring; Drug: Sevoflurane

• Registration Number: NCT03521414
• Lead Sponsor: Trakya University

Brief Summary

The study evaluates the general anesthesia management with BIS monitorization in terms of hemodynamic stability, drug concentrations and drug consumption in patients who underwent surgery due to intracranial pathology and who were divided in three different GCS groups.

Detailed Description

BIS monitoring is mostly used for anesthesia depth and sedation level follow-up, however it can also be used for monitoring consciousness after resuscitation of cases with acute brain injury and cardiac arrest. It is not always possible to monitor and objectively measure the changes in the level of consciousness in clinical practice. Therefore, device-based methods have been introduced in monitoring the state of consciousness. Bispectral index (BIS) monitoring may be preferred in follow up of the state of consciousness in critical patients such as those with acute brain injury, in terms of ease of use, ability to obtain numerical results and continuous monitoring. BIS monitoring is mostly used for follow up of anesthesia depth and sedation level, while it can also be applied for monitoring state of consciousness following resuscitation in cases with acute brain injury and cardiac arrest.In this study, we aimed to investigate general anesthesia management performed by bispectral index monitoring in patients who underwent surgery due to intracranial pathology and with different Glasgow Coma Scales.

Study Timeline

• Study Start: 2013-07-03
• Primary Completion: 2015-02
• Study Completion: 2015-11-05
• Status Verified: 2018-04
• Study First Submitted: 2018-04-24
• Study First Submitted QC: 2018-05-09
• Last Update Submitted: 2018-05-09
• Study First Posted: 2018-05-11
• Last Update Posted: 2018-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• 18 and 65 years
• ASA II-III
• intracranial surgery

Exclusion Criteria

• Patients with additional disease (electrolyte impairment, uremia, etc.),
• liver and renal failure affecting consciousness level other than intracranial pathology

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group I=13-15 mildly injured	Bispectral index (BIS) monitoring	Patients were divided into 3 groups according to the Glasgow Coma Scores calculated before surgery. use of anesthetic agent were recorded during bispectral index (BIS) monitoring and anesthesia application. we used sevoflurane drug intraoperative. Group I (n=15)=13-15 mildly injured
Group 2 =9-12 moderately damaged	Bispectral index (BIS) monitoring	Patients were divided into 3 groups according to the Glasgow Coma Scores calculated before surgery.use of anesthetic agent were recorded during bispectral index (BIS) monitoring and anesthesia application. we used sevoflurane drug intraoperative. Group 2 (n=15)=9-12 moderately damaged
Group 3=3-8 severely damaged.	Bispectral index (BIS) monitoring	Patients were divided into 3 groups according to the Glasgow Coma Scores calculated before surgery. use of anesthetic agent were recorded during bispectral index (BIS) monitoring and anesthesia application. we used sevoflurane drug intraoperative. Group 3 (n=15)=3-8 severely damaged.
Group 2 =9-12 moderately damaged	Sevoflurane	Patients were divided into 3 groups according to the Glasgow Coma Scores calculated before surgery.use of anesthetic agent were recorded during bispectral index (BIS) monitoring and anesthesia application. we used sevoflurane drug intraoperative. Group 2 (n=15)=9-12 moderately damaged
Group I=13-15 mildly injured	Sevoflurane	Patients were divided into 3 groups according to the Glasgow Coma Scores calculated before surgery. use of anesthetic agent were recorded during bispectral index (BIS) monitoring and anesthesia application. we used sevoflurane drug intraoperative. Group I (n=15)=13-15 mildly injured
Group 3=3-8 severely damaged.	Sevoflurane	Patients were divided into 3 groups according to the Glasgow Coma Scores calculated before surgery. use of anesthetic agent were recorded during bispectral index (BIS) monitoring and anesthesia application. we used sevoflurane drug intraoperative. Group 3 (n=15)=3-8 severely damaged.

Primary Outcome Measures

Name	Time	Method
BIS, Consumption of the inhalation agents	200 minutes	Preoperative, intraoperative and postoperative BIS values were recorded. The total; amount of opioid consumed was recorded from the infusion pump.