Glasgow Coma Scales and General Anesthesia

• ClinicalTrials.gov Identifier: NCT03521414
• Recruitment Status: Completed
• First Posted: May 11, 2018
• Last Update Posted: May 11, 2018
• Sponsor: Trakya University
• Information provided by (Responsible Party): Sevtap Hekimoglu Sahin, Trakya University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Anesthesia Awareness	Device: Bispectral index (BIS) monitoring; Drug: Sevoflurane	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 45 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Investigator)
• Primary Purpose: Other
• Official Title: The Effect of Glasgow Coma Scales on General Anesthesia in Neurosurgery Patients
• Actual Study Start Date: July 3, 2013
• Actual Primary Completion Date: February 2015
• Actual Study Completion Date: November 5, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. BIS, Consumption of the inhalation agents [ Time Frame: 200 minutes ]

   Preoperative, intraoperative and postoperative BIS values were recorded. The total

   amount of opioid consumed was recorded from the infusion pump.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Sevtap Hekimoglu Sahin, Director, clinical research, Trakya University
• ClinicalTrials.gov Identifier: NCT03521414
• Other Study ID Numbers: TÜTF-GOKAEK 2013/127
• First Posted: May 11, 2018
• Last Update Posted: May 11, 2018
• Last Verified: April 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sevtap Hekimoglu Sahin, Trakya University:

Bispectral index; Glasgow Coma Scale; intracranial pathology

Additional relevant MeSH terms:

Intraoperative Awareness; Intraoperative Complications; Pathologic Processes; Sevoflurane; Platelet Aggregation Inhibitors; Anesthetics, Inhalation; Anesthetics, General; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs