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

T

Trakya University

Status

Completed

Conditions

Lower Abdominal Surgery

Study type

Observational

Funder types

Other

Identifiers

NCT07102108
TUTF-GOBAEK 2023-25 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

180 patients

Sex

All

Ages

18 to 80 days old

Volunteers

No Healthy Volunteers

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

Trial design

180 participants in 4 patient groups

General Anesthesia
Description:
Patient receiving general anesthesia only for lower abdominal surgery
General+Epidural Anesthesia
Description:
Patient receiving combined general and epidural anesthesia for lower abdominal surgery
Spinal
Description:
Patient receiving spinal anesthesia only for lower abdominal surgery
Epidural Anesthesia
Description:
Patient receiving epidural anesthesia only for lower abdominal surgery

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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