Anesthesia AwarenessNCT03521414
Glasgow Coma Scales and General Anesthesia
A study testing Bispectral index (BIS) monitoring and Sevoflurane in people with Anesthesia Awareness, run by Trakya University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anesthesia Awareness
- What is being tested?
- Bispectral index (BIS) monitoring and Sevoflurane
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 3 Jul 2013to 5 Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 and 65 years
- ASA II-III
- intracranial surgery
Who cannot join
- Patients with additional disease (electrolyte impairment, uremia, etc.),
- liver and renal failure affecting consciousness level other than intracranial pathology
About this study
Official title: 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.
Read the 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.
- Conditions
- Anesthesia Awareness
- Being tested
- Bispectral index (BIS) monitoring, Sevoflurane
- Keywords
- Bispectral index, Glasgow Coma Scale, intracranial pathology
- Medical subject headings
- Intraoperative Awareness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bispectral index (BIS) monitoringDevice
When the patients were taken to the operation table, they were monitored with the BIS. we used sevoflurane drug
SevofluraneDrug
we used sevoflurane drug at inoperative
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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. Receives: Device: Bispectral index (BIS) monitoring; Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 200 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start3 Jul 2013
- Primary completionFeb 2015
- Study completion5 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia AwarenessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevtap Hekimoglu Sahin, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03521414
- Sponsor's protocol ID
- TÜTF-GOKAEK 2013/127
- Status last verified
- Apr 2018
- First submitted
- 24 Apr 2018
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Glasgow Coma Scales on General Anesthesia in Neurosurgery Patients
- ClinicalTrials.gov ID
- NCT03521414
- Acronym / sponsor ID
- TÜTF-GOKAEK 2013/127
- Conditions
- Anesthesia Awareness
- Keywords
- Bispectral index, Glasgow Coma Scale, intracranial pathology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 3 Jul 2013 (actual)
- Primary completion
- Feb 2015 (actual)
- Study completion
- 5 Nov 2015 (actual)
- First posted
- 11 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I=13-15 mildly injured | Active comparator | Device: Bispectral index (BIS) monitoring, Drug: SevofluranePatients 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 2 =9-12 moderately damaged | Active comparator | Device: Bispectral index (BIS) monitoring, Drug: SevofluranePatients 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 3=3-8 severely damaged. | Active comparator | Device: Bispectral index (BIS) monitoring, Drug: SevofluranePatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 and 65 years
- ASA II-III
- intracranial surgery
Key exclusion criteria (2 listed)
- Patients with additional disease (electrolyte impairment, uremia, etc.),
- liver and renal failure affecting consciousness level other than intracranial pathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bispectral index (BIS) monitoringWhen the patients were taken to the operation table, they were monitored with the BIS. we used sevoflurane drug | Device | Group 2 =9-12 moderately damaged, Group 3=3-8 severely damaged., Group I=13-15 mildly injured |
| Sevofluranewe used sevoflurane drug at inoperative | Drug | Group 2 =9-12 moderately damaged, Group 3=3-8 severely damaged., Group I=13-15 mildly injured |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Bispectral index (BIS) monitoring and Sevoflurane in people with Anesthesia Awareness, run by Trakya University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BIS, Consumption of the inhalation agents (time frame: 200 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2018.