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

NCT06781177 | Completed

• 1 other identifier: 2023-05/204
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia

Keywords

Anesthesia, Intravenous; Bispectral Index Monitor; Ketamine; Lidocaine; Spinal Fusion

Outcome Measures

Primary Outcomes (2)

• Postoperative Pain Score Using Visual Analog Scale (VAS)

  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.

  postoperative 24 hours

• Total Opioid Consumption in the First 24 Hours Postoperatively

  The total amount of opioids administered during the first 24 hours postoperatively will be recorded and converted to morphine milligram equivalents (MME).

  Postoperative 24 hours

Secondary Outcomes (4)

• Time to First Ambulation After Surgery

  postoperative 24 hours

• Time to First Bowel Movement After Surgery

  postoperative 24 hours

• Incidence of Nausea and Vomiting

  postoperative 24 hours

• Opioid Requirement Within After Surgery

  postoperative 1 month

Study Arms (3)

Group S

Propofol at 30-100 mcg/kg/min and remifentanil at 0.05-0.2 mcg/kg/min (classical TIVA)

Group K

Propofol at 30-100 mcg/kg/min, remifentanil at 0.05-0.1 mcg/kg/min, ketamine at 5 mcg/kg/min

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital: lead

Study Sites (1)

Dr Abdurrahman Yurtaslan Oncology Hospital

Ankara, Yenimahalle, 06200, Turkey (Türkiye)

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: specialist doctor, anesthesiologist

Study Record Dates

• First Submitted: December 29, 2024
• First Posted: January 17, 2025
• Study Start: May 10, 2023
• Primary Completion: November 10, 2023
• Study Completion: November 10, 2023
• Last Updated: January 17, 2025

Record last verified: 2025-01

Locations

TU (1)