Comparison of Total Intravenous Anesthesia Methods in Spinal Surgery (TIVA)

Completed

• Conditions: Anesthesia

• Registration Number: NCT06781177
• Lead Sponsor: Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-10
• Primary Completion: 2023-11-10
• Study Completion: 2023-11-10
• Study First Submitted: 2024-12-29
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-13
• Last Update Submitted: 2025-01-13
• Study First Posted: 2025-01-17
• Last Update Posted: 2025-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative Pain Score Using Visual Analog Scale (VAS)	postoperative 24 hours	Pain levels will be assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain), at 30 minutes, 2 hours, 6 hours, 12 hours, and 24 hours postoperatively.
Total Opioid Consumption in the First 24 Hours Postoperatively	Postoperative 24 hours	The total amount of opioids administered during the first 24 hours postoperatively will be recorded and converted to morphine milligram equivalents (MME).

Secondary Outcome Measures

Name	Time	Method
Time to First Bowel Movement After Surgery	postoperative 24 hours	The time from the end of surgery to the patient's first reported bowel movement will be recorded in hours.
Incidence of Nausea and Vomiting	postoperative 24 hours	The presence of postoperative nausea and vomiting will be recorded within the first 24 hours after surgery.
Time to First Ambulation After Surgery	postoperative 24 hours	The time from the end of surgery to the patient's first ambulation will be recorded in hours.
Opioid Requirement Within After Surgery	postoperative 1 month	The need for opioid use within 1 month after discharge will be evaluated through follow-up phone calls. The percentage of patients requiring opioids during this period will be recorded.

Trial Locations

Locations (1)

Dr Abdurrahman Yurtaslan Oncology Hospital; 🇹🇷 Ankara, Yenimahalle, Turkey