Bispectral Index MonitoringNCT07557433
Relationship Between Induction Burst Suppression and Bispectral Index
An observational study of Bispectral Index Monitoring and Burst Suppression, run by Amasya University at 2 sites in Turkey (Türkiye).
Trial summary
The purpose of this study is to understand whether certain brain activity patterns that can appear at the beginning of anesthesia are related to how deep anesthesia remains during the operation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bispectral Index Monitoring, Burst Suppression, Total Intravenous Anesthesia
- How many people
- 200 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Jul 2026to 1 Aug 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A tertiary care center in Amasya, Turkey
Who may be able to join
- Age between 18 and 75 years
- American Society of Anesthesiologists (ASA) physical status I-III
- Scheduled for elective surgery
- Surgery planned to be performed under total intravenous anesthesia (TIVA)
Who cannot join
- Presence of neurological disease
- Chronic use of sedative medications or antiepileptic drugs
- Severe hepatic or renal dysfunction
- Intraoperative administration of ketamine or dexmedetomidine
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Amasya University Sabuncuoglu Serefeddin Training and Research Hospital
Amasya, Amasya, 05200
Bülent Meriç Çam, MD, +90 (534) 8156011, bulentmericcam@gmail.com
- Not yet recruiting
Izmir Katip Celebi University Ataturk Training and Research Hospital
Izmir, İzmir, 35360
Ahmet Salih Tüzen, MD, +90 (535) 3915577, astuzen@icloud.com
About this study
Official title: The Relationship Between Burst Suppression Observed During Anesthesia Induction and the Bispectral Index Value During the Maintenance Phase of Anesthesia
The purpose of this study is to understand whether certain brain activity patterns that can appear at the beginning of anesthesia are related to how deep anesthesia remains during the operation.
The main question of the study is:
Read more
Do patients who show a pattern called burst suppression during the start of anesthesia experience deeper anesthesia during surgery?
Patients who are scheduled for elective surgery under total intravenous anesthesia (TIVA) may take part in this study. During the operation, brain activity will be monitored using a sensor placed on the forehead (Bispectral Index, BIS monitor), which is already commonly used during anesthesia. Information such as BIS values and the doses of anesthesia medications given during the operation will be recorded.
Participation in this study will not change the type of anesthesia or the routine care that patients receive during surgery. The study only involves recording and analyzing information collected during standard anesthesia monitoring.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Burst Suppression Group | Patients who exhibited burst suppression during the anesthesia induction period, defined as a burst suppression ratio of ≥10% lasting for at least 1 minute | |
| Non-Burst Suppression Group | Patients who did not exhibit burst suppression during the anesthesia induction period, defined as the absence of burst suppression with a burst suppression ratio ≥10% lasting for at least 1 minute |
What is being measured
The primary outcome is the main question the study is designed to answer.
TBIS<40
Total duration during the maintenance phase of anesthesia in which the BIS remains below 40, expressed as a proportion of total surgical time, compared between patients with and without burst suppression during induction
Measured: During intraoperative period
Secondary outcomes (8)
TBIS40-60
Duration during maintenance anesthesia in which BIS values remain between 40 and 60, expressed as a proportion of total surgical time.
Measured: During intraoperative period
TBIS>60
Duration during maintenance anesthesia in which BIS remains above 60, expressed as a proportion of total surgical time.
Measured: During intraoperative period
TLOC
Time to loss of consciousness :Time from induction agent administration to loss of consciousness. Loss of consciousness is defined as the moment when both the eyelash and corneal reflexes are abolished, and the time was recorded in seconds.
Measured: During induction of anesthesia
BIS-LOC
Bispectral Index (BIS) value at the time of loss of consciousness following induction of anesthesia. Loss of consciousness is defined as the moment when both the eyelash and corneal reflexes are abolished
Measured: At the exact time of loss of consciousness (LOC)
TROC
Time to return of consciousness:Time from discontinuation of anesthetic agents during the maintenance phase of anesthesia to return of consciousness. Return of consciousness was defined as the moment when the patient regained consciousness, demonstrated by eye opening and/or response to verbal commands, and the time was recorded in seconds
Measured: During emergence from anesthesia
BIS-ROC
Bispectral Index (BIS) value at the timeof return of consciousness. Return of consciousness was defined as the moment when the patient responded to verbal commands.
Measured: At the moment of response to verbal commands during emergence from anesthesia
Propofol infusion rate during anesthesia
Propofol administration will be recorded at 1-minute intervals throughout the intraoperative period. Additionally, total drug consumption during the procedure will be obtained from infusion pump records. Values recorded at 1-minute intervals will be used for time-based correlation analyses, while infusion pump data will be used to calculate mean infusion rates. The total amount of propofol administered during the entire surgical procedure will be calculated and expressed as mg/kg/hour.
Measured: During the intraoperative period
Remifentanil infusion rate during anesthesia
Remifentanil administration will be recorded at 1-minute intervals throughout the intraoperative period. Additionally, total drug consumption during the procedure will be obtained from infusion pump records. Values recorded at 1-minute intervals will be used for time-based correlation analyses, while infusion pump data will be used to calculate mean infusion rates. The total amount of remifentanil administered during the entire surgical procedure will be calculated and expressed as µg/kg/min
Measured: During the intraoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start1 Jul 2026
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bispectral Index MonitoringStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Amasya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bülent Meriç Çam, Amasya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07557433
- Sponsor's protocol ID
- 2026-82
- Status last verified
- Jul 2026
- First submitted
- 23 Apr 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Burst Suppression Observed During Anesthesia Induction and the Bispectral Index Value During the Maintenance Phase of Anesthesia
- ClinicalTrials.gov ID
- NCT07557433
- Acronym / sponsor ID
- 2026-82
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Amasya UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 29 Apr 2026 (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 purpose of this study is to understand whether certain brain activity patterns that can appear at the beginning of anesthesia are related to how deep anesthesia remains during the operation.
The main question of the study is:
Do patients who show a pattern called burst suppression during the start of anesthesia experience deeper anesthesia during surgery?
Patients who are scheduled for elective surgery under total intravenous anesthesia (TIVA) may take part in this study. During the operation, brain activity will be monitored using a sensor placed on the forehead (Bispectral Index, BIS monitor), which is already commonly used during anesthesia. Information such as BIS values and the doses of anesthesia medications given during the operation will be recorded.
Participation in this study will not change the type of anesthesia or the routine care that patients receive during surgery. The study only involves recording and analyzing information collected during standard anesthesia monitoring.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Burst Suppression Group | – | –Patients who exhibited burst suppression during the anesthesia induction period, defined as a burst suppression ratio of ≥10% lasting for at least 1 minute |
| Non-Burst Suppression Group | – | –Patients who did not exhibit burst suppression during the anesthesia induction period, defined as the absence of burst suppression with a burst suppression ratio ≥10% lasting for at least 1 minute |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A tertiary care center in Amasya, Turkey
Key inclusion criteria (4 listed)
- Age between 18 and 75 years
- American Society of Anesthesiologists (ASA) physical status I-III
- Scheduled for elective surgery
- Surgery planned to be performed under total intravenous anesthesia (TIVA)
Key exclusion criteria (4 listed)
- Presence of neurological disease
- Chronic use of sedative medications or antiepileptic drugs
- Severe hepatic or renal dysfunction
- Intraoperative administration of ketamine or dexmedetomidine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
TBIS<40
Time frame: During intraoperative period
Total duration during the maintenance phase of anesthesia in which the BIS remains below 40, expressed as a proportion of total surgical time, compared between patients with and without burst suppression during induction
8 secondary outcomes
TBIS40-60
Time frame: During intraoperative period
TBIS>60
Time frame: During intraoperative period
TLOC
Time frame: During induction of anesthesia
BIS-LOC
Time frame: At the exact time of loss of consciousness (LOC)
TROC
Time frame: During emergence from anesthesia
BIS-ROC
Time frame: At the moment of response to verbal commands during emergence from anesthesia
Propofol infusion rate during anesthesia
Time frame: During the intraoperative period
Remifentanil infusion rate during anesthesia
Time frame: During the intraoperative period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bispectral Index Monitoring and Burst Suppression, run by Amasya University at 2 sites in Turkey (Türkiye).
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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bülent Meriç Çam, MD (+90 (534) 815 6011, bulentmericcam@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TBIS<40 (time frame: During intraoperative period). 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 6 Jul 2026.