Glasgow Coma Scales and General Anesthesia

The Effect of Glasgow Coma Scales on General Anesthesia in Neurosurgery Patients

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia Awareness
• Intervention / Treatment: Device: Bispectral index (BIS) monitoring; Drug: Sevoflurane

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 Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Group I=13-15 mildly injured; 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	Device: Bispectral index (BIS) monitoring; When the patients were taken to the operation table, they were monitored with the BIS. we used sevoflurane drug; Drug: Sevoflurane; we used sevoflurane drug at inoperative
ACTIVE_COMPARATOR: Group 2 =9-12 moderately damaged; 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	Device: Bispectral index (BIS) monitoring; When the patients were taken to the operation table, they were monitored with the BIS. we used sevoflurane drug; Drug: Sevoflurane; we used sevoflurane drug at inoperative
ACTIVE_COMPARATOR: Group 3=3-8 severely damaged.; 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.	Device: Bispectral index (BIS) monitoring; When the patients were taken to the operation table, they were monitored with the BIS. we used sevoflurane drug; Drug: Sevoflurane; we used sevoflurane drug at inoperative

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BIS, Consumption of the inhalation agents	Preoperative, intraoperative and postoperative BIS values were recorded. The total amount of opioid consumed was recorded from the infusion pump.	200 minutes

Collaborators and Investigators

• Sponsor: Trakya University

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 3, 2013
• Primary Completion (ACTUAL): February 1, 2015
• Study Completion (ACTUAL): November 5, 2015

Study Registration Dates

• First Submitted: April 24, 2018
• First Submitted That Met QC Criteria: May 9, 2018
• First Posted (ACTUAL): May 11, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 11, 2018
• Last Update Submitted That Met QC Criteria: May 9, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Bispectral index; Glasgow Coma Scale; intracranial pathology
• Additional Relevant MeSH Terms: Pathologic Processes; Intraoperative Complications; Intraoperative Awareness; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, General; Anesthetics; Platelet Aggregation Inhibitors; Anesthetics, Inhalation; Sevoflurane
• Other Study ID Numbers: TÜTF-GOKAEK 2013/127

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No