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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Ambulation After Surgery | The time from the end of surgery to the patient's first ambulation will be recorded in hours. | postoperative 24 hours |
| Time to First Bowel Movement After Surgery |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr Abdurrahman Yurtaslan Oncology Hospital | Ankara | Yenimahalle | 06200 | Turkey (Türkiye) |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 10, 2023 | Jan 3, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 10, 2023 | Jan 3, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 10, 2023 | Jan 3, 2025 | ICF_002.pdf |
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The time from the end of surgery to the patient's first reported bowel movement will be recorded in hours.
| postoperative 24 hours |
| Incidence of Nausea and Vomiting | The presence of postoperative nausea and vomiting will be recorded within the first 24 hours after surgery. | postoperative 24 hours |
| Opioid Requirement Within After Surgery | 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. | postoperative 1 month |