Comparison of Total Intravenous Anesthesia Methods in Spinal Surgery (TIVA)
NCT ID: NCT06781177
Last Updated: 2025-01-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
72 participants
OBSERVATIONAL
2023-05-10
2023-11-10
Brief Summary
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A prospective observational study was conducted with 72 patients undergoing posterior thoracolumbar spinal fusion surgeries. Patients were evenly divided into three groups: classical TIVA (propofol and remifentanil), TIVA + ketamine, and TIVA + lidocaine. Hemodynamic parameters and drug dosages were recorded during the intraoperative period, while pain scores, opioid consumption, time to first ambulation and bowel movement, as well as nausea-vomiting and sedation scores, were documented postoperatively.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Group S
Propofol at 30-100 mcg/kg/min and remifentanil at 0.05-0.2 mcg/kg/min (classical TIVA)
No interventions assigned to this group
Group K
Propofol at 30-100 mcg/kg/min, remifentanil at 0.05-0.1 mcg/kg/min, ketamine at 5 mcg/kg/min
No interventions assigned to this group
Group L
Propofol at 30-100 mcg/kg/min, remifentanil at 0.05-0.1 mcg/kg/min, lidocaine at 1.2 mg/kg/h
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* ASA classification I-III
* Patients undergoing posterior thoracolumbar spinal surgery and neuromonitoring under general anesthesia
Exclusion Criteria
* Pregnant patients
* Patients with ASA classification IV or higher\*
* Patients allergic to morphine and local anesthetics
* Patients with neurological or psychiatric disorders (on ongoing antidepressant and/or anticonvulsant therapy) Illiterate patients
* Patients unable to cooperate
* Extremely low or high body weight (less than 40 kg or more than 100 kg)
* Chronic opioid use
* Diabetes mellitus (DM) requiring insulin therapy
* Chronic alcohol use
* Patients with peripheral neuropathy
* Patients with cardiac arrhythmias
18 Years
75 Years
ALL
Yes
Sponsors
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Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
OTHER
Responsible Party
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Aysegul Danaci
specialist doctor, anesthesiologist
Locations
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Dr Abdurrahman Yurtaslan Oncology Hospital
Ankara, Yenimahalle, Turkey (Türkiye)
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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2023-05/204
Identifier Type: -
Identifier Source: org_study_id
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