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Completed

NCT Number: NCT06781177

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

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.

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Key information

Conditions

Anesthesia

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dr Abdurrahman Yurtaslan Oncology Hospital

Ankara, Yenimahalle, 06200, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Postoperative Pain Score Using Visual Analog Scale (VAS)

    Time frame: 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.

  2. Total Opioid Consumption in the First 24 Hours Postoperatively

    Time frame: 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 outcomes

  1. Time to First Ambulation After Surgery

    Time frame: postoperative 24 hours

    The time from the end of surgery to the patient's first ambulation will be recorded in hours.

  2. Time to First Bowel Movement After Surgery

    Time frame: postoperative 24 hours

    The time from the end of surgery to the patient's first reported bowel movement will be recorded in hours.

  3. Incidence of Nausea and Vomiting

    Time frame: postoperative 24 hours

    The presence of postoperative nausea and vomiting will be recorded within the first 24 hours after surgery.

  4. Opioid Requirement Within After Surgery

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Other

Registry information

Official study title

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

Acronym: TIVA

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 17, 2025
Registry last updated
Jan 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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