Glasgow Coma Scales and General Anesthesia

T

Trakya University

Status

Completed

Conditions

Anesthesia Awareness

Treatments

Drug: Sevoflurane
Device: Bispectral index (BIS) monitoring

Study type

Interventional

Funder types

Other

Identifiers

NCT03521414
TÜTF-GOKAEK 2013/127

Details and patient eligibility

About

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.

Full 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.

Enrollment

45 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

45 participants in 3 patient groups

Group I=13-15 mildly injured
Active Comparator group
Description:
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
Treatment:
Device: Bispectral index (BIS) monitoring
Drug: Sevoflurane
Group 2 =9-12 moderately damaged
Active Comparator group
Description:
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
Treatment:
Device: Bispectral index (BIS) monitoring
Drug: Sevoflurane
Group 3=3-8 severely damaged.
Active Comparator group
Description:
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.
Treatment:
Device: Bispectral index (BIS) monitoring
Drug: Sevoflurane

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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