Clinical trial NCT06781177: Comparison of Total Intravenous Anesthesia Methods in Spinal Surgery (TIVA)
Official title: Comparison of Total Intravenous Anesthesia Methods in Terms of Postoperative Outcomes in Thoracolumbar Spinal Surgery Cases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia
Keywords: Anesthesia, Intravenous
Bispectral Index Monitor
Ketamine
Lidocaine
Spinal Fusion
Lead sponsor: Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Sponsor class: OTHER
First posted: 2025-01-17
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients aged 18 years or older, classified as ASA I-III, undergoing posterior thoracolumbar spinal surgery and neuromonitoring under general anesthesia, and fluent in Turkish.

Brief summary: This study aims to compare the effects of the classical Total Intravenous Anesthesia (TIVA) method and multimodal anesthesia protocols created by adding lidocaine and ketamine infusions on postoperative pain management, opioid consumption, and surgical recovery in posterior thoracolumbar spinal fusion surgeries.

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.


Eligibility criteria: Inclusion Criteria:

* Aged 18 years or older,
* ASA classification I-III
* Patients undergoing posterior thoracolumbar spinal surgery and neuromonitoring under general anesthesia

Exclusion Criteria:

* Emergency operations
* 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

Primary outcomes:
measure: Postoperative Pain Score Using Visual Analog Scale (VAS)
timeFrame: postoperative 24 hours
measure: Total Opioid Consumption in the First 24 Hours Postoperatively
timeFrame: Postoperative 24 hours
Secondary outcomes:
measure: Time to First Ambulation After Surgery
timeFrame: postoperative 24 hours
measure: Time to First Bowel Movement After Surgery
timeFrame: postoperative 24 hours
measure: Incidence of Nausea and Vomiting
timeFrame: postoperative 24 hours
measure: Opioid Requirement Within After Surgery
timeFrame: postoperative 1 month
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Dr Abdurrahman Yurtaslan Oncology Hospital
state: Yenimahalle
Study officials:
References: