Glasgow Coma Scales and General Anesthesia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-03

Study Completion Date

2015-11-05

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Anesthesia Awareness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Investigators

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Bispectral index (BIS) monitoring

Intervention Type DEVICE

When the patients were taken to the operation table, they were monitored with the BIS. we used sevoflurane drug

Sevoflurane

Intervention Type DRUG

we used sevoflurane drug at inoperative

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

Group Type ACTIVE_COMPARATOR

Bispectral index (BIS) monitoring

Intervention Type DEVICE

When the patients were taken to the operation table, they were monitored with the BIS. we used sevoflurane drug

Sevoflurane

Intervention Type DRUG

we used sevoflurane drug at inoperative

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.

Group Type ACTIVE_COMPARATOR

Bispectral index (BIS) monitoring

Intervention Type DEVICE

When the patients were taken to the operation table, they were monitored with the BIS. we used sevoflurane drug

Sevoflurane

Intervention Type DRUG

we used sevoflurane drug at inoperative

Interventions

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Bispectral index (BIS) monitoring

When the patients were taken to the operation table, they were monitored with the BIS. we used sevoflurane drug

Intervention Type DEVICE

Sevoflurane

we used sevoflurane drug at inoperative

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No