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

Comparison of Total Intravenous Anesthesia Methods in Terms of Postoperative Outcomes in Thoracolumbar Spinal Surgery Cases

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06781177

Acronym

TIVA

Enrollment

Registered

2025-01-17

Start date

2023-05-10

Completion date

2023-11-10

Last updated

2025-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Keywords

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

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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.
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.

Countries

Turkey (Türkiye)

Outcome results