Glasgow Coma Scales and General Anesthesia

NCT03521414 | Completed

• 1 other identifier: TÜTF-GOKAEK 2013/127
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anesthesia Awareness

Keywords

Bispectral index; Glasgow Coma Scale; intracranial pathology

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Group I=13-15 mildly injured

ACTIVE COMPARATOR

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; Drug: Sevoflurane

Group 2 =9-12 moderately damaged

ACTIVE COMPARATOR

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; Drug: Sevoflurane

Group 3=3-8 severely damaged.

ACTIVE COMPARATOR

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; Drug: Sevoflurane

Interventions

Bispectral index (BIS) monitoring DEVICE

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

Group 2 =9-12 moderately damaged; Group 3=3-8 severely damaged.; Group I=13-15 mildly injured

Sevoflurane DRUG

we used sevoflurane drug at inoperative

Group 2 =9-12 moderately damaged; Group 3=3-8 severely damaged.; Group I=13-15 mildly injured

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Trakya University: lead

MeSH Terms

Conditions

Intraoperative Awareness

Interventions

Sevoflurane

Condition Hierarchy (Ancestors)

Intraoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, clinical research

Study Record Dates

• First Submitted: April 24, 2018
• First Posted: May 11, 2018
• Study Start: July 3, 2013
• Primary Completion: February 1, 2015
• Study Completion: November 5, 2015
• Last Updated: May 11, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share