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| ID | Type | Description | Link |
|---|---|---|---|
| TUTF-GOBAEK 2023-25 | Other Identifier | Trakya University/Faculty of Medicine Ethics Committee |
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This is a prospective observational study designed to evaluate the effects of different anesthesia techniques on tissue oxygenation and postoperative recovery in patients undergoing lower abdominal surgery. A total of 180 patients will be enrolled and evenly allocated into four groups based on the anesthesia method used: general anesthesia, spinal anesthesia, epidural anesthesia, and combined general plus epidural anesthesia.
Near-infrared spectroscopy (NIRS) will be utilised to monitor tissue oxygenation at the thenar and plantar regions during the perioperative period. Vital signs, VAS scores(min 0-max 10 points), Quality of Recovery-40 (QoR-40) scores(min 40-max 200 points), and additional postoperative recovery parameters- including length of stay in the post-anesthesia care unit and hospital, surgical site infection, wound revision, and mortality- will be recorded and compared across the groups.
The primary hypothesis is that regional anesthesia techniques enchance tissue oxygenation and are associated with improved postoperative recovery outcomes compared to general anesthesia alone. The study was approved by the local ethics committee and will be conducted at a single tertiary-care center.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| General Anesthesia | Patient receiving general anesthesia only for lower abdominal surgery | ||
| General+Epidural Anesthesia | Patient receiving combined general and epidural anesthesia for lower abdominal surgery | ||
| Spinal | Patient receiving spinal anesthesia only for lower abdominal surgery | ||
| Epidural Anesthesia | Patient receiving epidural anesthesia only for lower abdominal surgery |
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| Measure | Description | Time Frame |
|---|---|---|
| Tissue Oxygenation Levels Measured by NIRS | Continuous measurement of tissue oxygenation at thenar and plantar sites using near-infrared spectroscopy during perioperative period | From baseline(pre-op) to end of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative Vital Signs | Systolic blood pressure recorded during anesthesia | Intraoperative period |
| Intraoperative Vital Signs | Diastolic blood pressure recorded during anesthesia |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients aged 18-80 undergoing elective lower abdominal surgeries under one of four anesthesia techniques (general, spinal, epidural, or combined general+epidural) at a single tertiary hospital. Patients with peripheral vascular disease, severe cardiopulmonary instability, or cognitive/communication limitations were excluded.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Trakya University, Faculty of Medicine | Edirne | Central | 22100 | Turkey (Türkiye) |
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| Intraoperative period |
| Intraoperative Vital Signs | Heart rate recorded during anesthesia | Intraoperative period |
| Intraoperative Vital Signs | Oxygenation saturation recorded during anesthesia | Intraoperative period |
| Visual Analog Scale(VAS) Pain Scores | VAS pain scores measured postoperatively at PACU and postoperative day 1. The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain. Higher scores indicate worse outcomes. | Up to 24 hours after surgery |
| Qor-40 Questionnaire Scores | Quality of Recovery scores assessed using the Qor-40 questionnaire on postoperative day1. The total score ranges from 40 to 200, with higher scores indicating better recovery. | postoperative day 1 |