- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07650604
Bispectral Index in Patients Undergoing Vertebral Surgery Using Artificial Intelligence Programs: A Methodological Study (BIS)
June 12, 2026 updated by: Antalya Health Sciences University
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 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 Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Estimated)
63
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Tayfun Sugur, specialezed
- Phone Number: +90 534 564 79 09
- Email: drtyfnsgr@gmail.com
Study Locations
-
-
Muratpaşa
-
Antalya, Muratpaşa, Turkey (Türkiye)
- University of Health Sciences, Antalya Training and Research Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- elective vertebra surgery
- aged 18-65
- ASA score I-III
- BMI <30 kg/m2
Exclusion Criteria:
- 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,
- history of previous intracranial aneurysm or intracranial tumor surgery
- history of moderate or severe pulmonary disease,
- emergency surgery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
CHATGPT GROUP
|
CHATGPT responses
|
|
GEMİNİ GROUP
|
GEMİNİ responses
|
|
COPİLOT GROUP
|
COPİLOT responses
|
|
CLINICIAN GROUP
|
Clinicians responses
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical Experience
Time Frame: 12 hours
|
The proximity of AI programs to the clinical experience
|
12 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Tayfun Sugur, University of Health Sciences, Antalya Training and Research Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
June 10, 2026
Primary Completion (Estimated)
September 10, 2026
Study Completion (Estimated)
December 10, 2026
Study Registration Dates
First Submitted
June 9, 2026
First Submitted That Met QC Criteria
June 12, 2026
First Posted (Actual)
June 16, 2026
Study Record Updates
Last Update Posted (Actual)
June 16, 2026
Last Update Submitted That Met QC Criteria
June 12, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- 9/3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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