CompletedNot Applicable

Effects of Anesthesia Techniques on Tissue Oxygenation and Recovery in Lower Abdominal Surgery

Turkey (Türkiye)180 participantsStarted 2023-03-01

Plain-language summary

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.

Who can participate

Age range

18 Days – 80 Days

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adults aged 18-80 years * Scheduled for elective lower abdominal surgery * Eligible for general, spinal, epidural or combined anesthesia techniques * Provided writen informed consent * ASA physical status 1-3 Exclusion Criteria: * Refusal to participate * Emergency surgery * Severe cardiovascular or respiratory instability * Pre-existing severe cognitive impairment of communication barrier * Peripheral vascular disease affecting NIRS readind * Local infection or anatomical anomaly preventing regional anesthesia

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Tissue Oxygenation Levels Measured by NIRS

Timeframe: From baseline(pre-op) to end of surgery

Trial details

NCT IDNCT07102108

SponsorTrakya University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-03-01

View on ClinicalTrials.gov More Lower Abdominal Surgery trials