Artifical IntelligenceBISNCT07650604
Bispectral Index in Patients Undergoing Vertebral Surgery Using Artificial Intelligence Programs: A Methodological Study
An observational study of Artifical Intelligence and Bispectral Index, run by Antalya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to interpret the Bispectral Index (BIS) monitoring method, which we routinely use for monitoring in scoliosis surgery, with artificial intelligence (AI) tools and to determine the accuracy and reliability of AI tools in clinical practice by comparing this interpretation with the interpretations of two… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Artifical Intelligence, Bispectral Index, Spine
- What is being tested?
- CHATGPT Group, GEMİNİ group and COPİLOT group
- How many people
- 63 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jun 2026to 10 Dec 2026
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18-65 years with ASA scores I-III and BMI <30 kg/m2 who are scheduled for elective vertebra surgery will be included.
Who may be able to join
- elective vertebra surgery
- aged 18-65
- ASA score I-III
- BMI <30 kg/m2
Who cannot join
- patient's refusal
- BMI >30 kg/m2
- serious liver or kidney disease
- ASA 4 ve more
- anatomical abnormality at probe site
- history of mental or neurological disease,
Show all 9Show fewer
- history of previous intracranial aneurysm or intracranial tumor surgery
- history of moderate or severe pulmonary disease,
- emergency surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
University of Health Sciences, Antalya Training and Research Hospital
Antalya, Muratpaşa
About this study
Official title: INTERPRETATION AND EVULATION OF THE PROXIMITY TO CLINICAL EXPERIENCE OF BISPECTRAL INDEX (BIS) IN PATIENTS UNDERGOİNG VERTEBRAL SURGERY USING ARTIFICIAL INTELLIGENCE PROGRAMS: A METHODOLOGICAL STUDY
This study aims to interpret the Bispectral Index (BIS) monitoring method, which we routinely use for monitoring in scoliosis surgery, with artificial intelligence (AI) tools and to determine the accuracy and reliability of AI tools in clinical practice by comparing this interpretation with the interpretations of two clinicians experienced in BIS.
Read the detailed description
The Bispectral Index (BIS) is an FDA-approved method for monitoring the depth of anesthesia. BIS combines time-domain, frequency-domain, and bispectral analysis of electroencephalography and is displayed as a dimensionless number between 0 (deep anesthesia) and 100 (awake); a value between 40 and 60 is suitable for surgical anesthesia. BIS shows good correlation with hypnotic state and anesthetic drug concentration, and its use can shorten recovery times. Recently, the use of artificial intelligence (AI) tools (Gemini 3.1, ChatCPT 5.5, Copilot 365 Premium) has become widespread in all fields. However, in the medical literature, there are only a limited number of recent studies that aim to enable emergency intervention in patients, increase clinical use, and obtain advice even if treatment recommendations are not available. Therefore, this study aims to interpret the BIS monitoring method, which we routinely use for monitoring in scoliosis surgery, with AI tools and to determine the accuracy and reliability of AI tools in clinical practice by comparing this interpretation with the interpretations of two clinicians experienced in BIS.
- Conditions
- Artifical Intelligence, Bispectral Index, Spine
- Being tested
- CHATGPT Group, GEMİNİ group, COPİLOT group, CLINICIAN group
- Keywords
- artificial intelligence, bispectral index, vertebra surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHATGPT GroupOther
CHATGPT responses
GEMİNİ groupOther
GEMİNİ responses
COPİLOT groupOther
COPİLOT responses
CLINICIAN groupOther
Clinicians responses
| Study group | Role | What they receive |
|---|---|---|
| CHATGPT Group | Not described Receives: Other: CHATGPT Group | |
| GEMİNİ Group | Not described Receives: Other: GEMİNİ group | |
| COPİLOT Group | Not described Receives: Other: COPİLOT group | |
| CLINICIAN Group | Not described Receives: Other: CLINICIAN group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Experience
The proximity of AI programs to the clinical experience. The study will examine the percentage of times AI programs' interpretations and intervention recommendations regarding information processing stimulus (ISIS) are identical to those of two clinical practitioners.
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start10 Jun 2026 (estimated)
- Primary completion10 Sep 2026 (estimated)
- Study completion10 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Artifical IntelligenceStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Antalya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tayfun Sugur, Principal investigator, University of Health Sciences, Antalya Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07650604
- Sponsor's protocol ID
- 9/3
- Acronym
- BIS
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2026
- Last updated
- 24 Jun 2026
- 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 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INTERPRETATION AND EVULATION OF THE PROXIMITY TO CLINICAL EXPERIENCE OF BISPECTRAL INDEX (BIS) IN PATIENTS UNDERGOİNG VERTEBRAL SURGERY USING ARTIFICIAL INTELLIGENCE PROGRAMS: A METHODOLOGICAL STUDY
- ClinicalTrials.gov ID
- NCT07650604
- Acronym / sponsor ID
- BIS / 9/3
- Conditions
- Artifical Intelligence, Bispectral Index, Spine
- Keywords
- artificial intelligence, bispectral index, vertebra surgery
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Antalya Health Sciences UniversityUniversity, hospital or other
- Study start
- 10 Jun 2026 (estimated)
- Primary completion
- 10 Sep 2026 (estimated)
- Study completion
- 10 Dec 2026 (estimated)
- First posted
- 16 Jun 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.
This study aims to interpret the Bispectral Index (BIS) monitoring method, which we routinely use for monitoring in scoliosis surgery, with artificial intelligence (AI) tools and to determine the accuracy and reliability of AI tools in clinical practice by comparing this interpretation with the interpretations of two clinicians experienced in BIS.
Detailed description
The Bispectral Index (BIS) is an FDA-approved method for monitoring the depth of anesthesia. BIS combines time-domain, frequency-domain, and bispectral analysis of electroencephalography and is displayed as a dimensionless number between 0 (deep anesthesia) and 100 (awake); a value between 40 and 60 is suitable for surgical anesthesia. BIS shows good correlation with hypnotic state and anesthetic drug concentration, and its use can shorten recovery times. Recently, the use of artificial intelligence (AI) tools (Gemini 3.1, ChatCPT 5.5, Copilot 365 Premium) has become widespread in all fields. However, in the medical literature, there are only a limited number of recent studies that aim to enable emergency intervention in patients, increase clinical use, and obtain advice even if treatment recommendations are not available. Therefore, this study aims to interpret the BIS monitoring method, which we routinely use for monitoring in scoliosis surgery, with AI tools and to determine the accuracy and reliability of AI tools in clinical practice by comparing this interpretation with the interpretations of two clinicians experienced in BIS.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CHATGPT Group | – | Other: CHATGPT Group |
| GEMİNİ Group | – | Other: GEMİNİ group |
| COPİLOT Group | – | Other: COPİLOT group |
| CLINICIAN Group | – | Other: CLINICIAN group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18-65 years with ASA scores I-III and BMI <30 kg/m2 who are scheduled for elective vertebra surgery will be included.
Key inclusion criteria (4 listed)
- elective vertebra surgery
- aged 18-65
- ASA score I-III
- BMI <30 kg/m2
Key exclusion criteria (9 listed)
- patient's refusal
- BMI >30 kg/m2
- serious liver or kidney disease
- ASA 4 ve more
- anatomical abnormality at probe site
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 |
|---|---|---|
| CHATGPT GroupCHATGPT responses | Other | CHATGPT Group |
| GEMİNİ groupGEMİNİ responses | Other | GEMİNİ Group |
| COPİLOT groupCOPİLOT responses | Other | COPİLOT Group |
| CLINICIAN groupClinicians responses | Other | CLINICIAN Group |
Primary outcome
Clinical Experience
Time frame: 12 hours
The proximity of AI programs to the clinical experience. The study will examine the percentage of times AI programs' interpretations and intervention recommendations regarding information processing stimulus (ISIS) are identical to those of two clinical practitioners.
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 24 Jun 2026.
- 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.
Tayfun Sugur principal investigator
University of Health Sciences, Antalya Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Artifical Intelligence and Bispectral Index, run by Antalya Health Sciences University at 1 site 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 9 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: opening soon, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Tayfun Sugur, specialezed (+90 534 564 79 09, drtyfnsgr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Experience (time frame: 12 hours). 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 24 Jun 2026.