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

NCT07102108 | Completed

• 1 other identifier: TUTF-GOBAEK 2023-25
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lower Abdominal Surgery

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Intraoperative Vital Signs

  Intraoperative period

• Intraoperative Vital Signs

  Intraoperative period

• Intraoperative Vital Signs

  Intraoperative period

• Intraoperative Vital Signs

  Intraoperative period

• Visual Analog Scale(VAS) Pain Scores

  Up to 24 hours after surgery

Study Arms (4)

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

Eligibility Criteria

• Age: 18 Days - 80 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Trakya University: lead

Study Sites (1)

Trakya University, Faculty of Medicine

Edirne, Central, 22100, Turkey (Türkiye)

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant-Anestesthesiology and Reanimation

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: August 3, 2025
• Study Start: March 1, 2023
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)