Machine Learning for Predicting Spinal Anesthesia Duration

NCT ID: NCT07256548

Last Updated: 2025-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-31

Study Completion Date

2026-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Spinal anesthesia provides significant advantages over general anesthesia in knee arthroplasty, including reduced blood loss, faster recovery, and fewer complications. However, predicting its duration is critical for patient safety and effective postoperative management. This study evaluates the usability of machine learning (ML) algorithms to predict the termination time of spinal anesthesia and the patient's readiness for mobilization. Using demographic, surgical, and anesthetic variables, ML models were trained to estimate anesthesia duration. Accurate predictions may improve intraoperative planning, optimize postoperative care, and enhance patient outcomes. Integrating ML-based predictive systems into anesthesia practice can contribute to safer, more efficient, and personalized perioperative management.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Abstract

Spinal anesthesia offers several advantages over general anesthesia in total knee arthroplasty, including reduced intraoperative blood loss, less postoperative pain, faster recovery, and shorter hospital stays. It also minimizes anesthesia-related complications and facilitates early mobilization, making it a preferred technique for many orthopedic procedures. However, predicting the exact duration of spinal anesthesia remains challenging and is clinically significant for ensuring patient safety, optimizing postoperative pain control, and preventing anesthesia-related complications.

Accurate estimation of anesthesia duration allows for more effective surgical planning, timely analgesia administration, and improved patient satisfaction. Unexpectedly prolonged anesthesia may increase the risk of adverse effects, whereas premature termination can result in inadequate pain management.

Machine learning (ML) technologies offer promising tools for predicting clinical outcomes in anesthesia practice by analyzing complex, multidimensional datasets. Previous research has demonstrated the potential of ML algorithms to predict perioperative events such as hypotension, blood transfusion requirements, and postoperative complications.

In this study, the usability and effectiveness of ML models in predicting the time of termination of spinal anesthesia and the patient's readiness for mobilization were investigated. By incorporating multiple clinical variables-such as patient demographics, anesthetic drug dosages, and surgical factors-our model aims to provide accurate, data-driven predictions. These predictive insights can support anesthesiologists in tailoring perioperative management, reducing complication risks, and improving overall patient outcomes. Ultimately, integrating ML-based prediction systems into anesthesia practice may enhance the safety, efficiency, and personalization of perioperative care.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Spinal Anesthesia Machine Learning Knee Arthroplasty, Total Spinal Anesthesia Duration Postoperative Care Postoperative Acute Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Knee Arthroplasty Group

The group of patients who will undergo knee replacement surgery under spinal anesthesia

Spinal Anesthesia (bupivacaine)

Intervention Type PROCEDURE

Before being placed on the operating table, the patient is positioned comfortably and prepared for the procedure. Standardized monitoring is initiated, including five-lead electrocardiography (ECG), non-invasive blood pressure (NIBP), and pulse oximetry (SpO₂). Baseline measurements of heart rate, systolic and diastolic blood pressure, mean arterial pressure (MAP), and oxygen saturation are recorded. An 18- or 20-gauge intravenous line is inserted, and an appropriate crystalloid preload is administered. After ensuring aseptic conditions, the patient is positioned in the sitting posture, and spinal puncture is performed at the L3-L4 or L4-L5 intervertebral space using a 25 Gauge Whitacre needle. Following free flow of cerebrospinal fluid, 0.5% hyperbaric bupivacaine (10-15 mg) is slowly injected. The completion of the injection is

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Spinal Anesthesia (bupivacaine)

Before being placed on the operating table, the patient is positioned comfortably and prepared for the procedure. Standardized monitoring is initiated, including five-lead electrocardiography (ECG), non-invasive blood pressure (NIBP), and pulse oximetry (SpO₂). Baseline measurements of heart rate, systolic and diastolic blood pressure, mean arterial pressure (MAP), and oxygen saturation are recorded. An 18- or 20-gauge intravenous line is inserted, and an appropriate crystalloid preload is administered. After ensuring aseptic conditions, the patient is positioned in the sitting posture, and spinal puncture is performed at the L3-L4 or L4-L5 intervertebral space using a 25 Gauge Whitacre needle. Following free flow of cerebrospinal fluid, 0.5% hyperbaric bupivacaine (10-15 mg) is slowly injected. The completion of the injection is

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Patients scheduled to undergo total knee arthroplasty between November 2025 and March 2026 at the Kocaeli City Hospital Operating Theaters.
2. Patients who have provided written informed consent to participate in the study.
3. Patients whose surgery is planned under spinal anesthesia.
4. Patients for whom complete clinical data can be obtained during the study period.
5. Adults aged 18 years or older, classified as American Society of Anesthesiologist's (ASA) Physical Status I or II.

Exclusion Criteria

1. Patients who were converted to general anesthesia during surgery or initially operated under general anesthesia.
2. Patients who required postoperative intensive care unit (ICU) admission following anesthesia.
3. Patients who developed surgical complications and for whom postoperative mobilization could not be planned.
4. Patients with cognitive impairment preventing them from completing pain assessment scales in the postoperative period.
5. Patients with neuropathic pain, multiple sclerosis, or other neuromotor disorders will be excluded from the study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Kocaeli City Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sıddık Varolgunes

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ahmet Yüksek, MD

Role: STUDY_DIRECTOR

Kocaeli City Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kocaeli City Hospital

Kocaeli, İzmit, Turkey (Türkiye)

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Sıddık Varolgüneş, MD

Role: CONTACT

+905319179657

Ahmet Yüksek, MD

Role: CONTACT

+905326580351

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Ahmet Yüksek, MD

Role: primary

+905326580351

References

Explore related publications, articles, or registry entries linked to this study.

Bellini V, Russo M, Domenichetti T, Panizzi M, Allai S, Bignami EG. Artificial Intelligence in Operating Room Management. J Med Syst. 2024 Feb 14;48(1):19. doi: 10.1007/s10916-024-02038-2.

Reference Type BACKGROUND
PMID: 38353755 (View on PubMed)

Cao Y, Wang Y, Liu H, Wu L. Artificial intelligence revolutionizing anesthesia management: advances and prospects in intelligent anesthesia technology. Front Med (Lausanne). 2025 Aug 6;12:1571725. doi: 10.3389/fmed.2025.1571725. eCollection 2025.

Reference Type BACKGROUND
PMID: 40842529 (View on PubMed)

Magdic Turkovic T, Sabo G, Babic S, Sostaric S. SPINAL ANESTHESIA IN DAY SURGERY - EARLY EXPERIENCES. Acta Clin Croat. 2022 Sep;61(Suppl 2):160-164. doi: 10.20471/acc.2022.61.s2.22.

Reference Type BACKGROUND
PMID: 36824644 (View on PubMed)

Boublik J, Gupta R, Bhar S, Atchabahian A. Prilocaine spinal anesthesia for ambulatory surgery: A review of the available studies. Anaesth Crit Care Pain Med. 2016 Dec;35(6):417-421. doi: 10.1016/j.accpm.2016.03.005. Epub 2016 Jun 21.

Reference Type BACKGROUND
PMID: 27352633 (View on PubMed)

Schubert AK, Wiesmann T, Wulf H, Dinges HC. Spinal anesthesia in ambulatory surgery. Best Pract Res Clin Anaesthesiol. 2023 Jun;37(2):109-121. doi: 10.1016/j.bpa.2023.04.002. Epub 2023 Apr 15.

Reference Type BACKGROUND
PMID: 37321760 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KSH_SVG_1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.