COMPARISON OF OXIDANT-ANTIOXIDANT LEVELS WITH STRESS HORMONES IN SPINAL ANESTHESIA AND GENERAL ANESTHESIA IN LAPAROSCOPIC TUBE LIGATION

NCT06710522 | Enrolling By Invitation

• 1 other identifier: AEŞH-EK1-2023-478
• Study Type: observational
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this observational study is to investigate the effect of anesthesia method applied in laparoscopic tubal ligation on stress factors in women aged 15-45. The main question it aims to answer is: Do spinal anesthesia and general anesthesia applied during laparoscopic tubal ligation surgery cause a change in the body's stress hormones? Do patients who undergo spinal anesthesia produce less oxidant-antioxidant than patients who undergo general anesthesia? Patients will answer the State and Trait Anxiety Scale questions before the operation

Conditions

Gynecologic Laparoscopic Surgery

Keywords

spinal anesthesia; general anesthesia; cortisol; acth; native thiol; total thiol; disulfide

Outcome Measures

Primary Outcomes (2)

• kortizol-acth levels

  Determination of differences in cortisol and ACTH hormones in patients who underwent bilateral tubal ligation with spinal anesthesia compared to patients who underwent bilateral tubal ligation with general anesthesia.

  from december 2024 to january 2025

• oxidant-antioxidan levels

  Determination of differences in oxidant-antioxidant values in patients who underwent bilateral tubal ligation with spinal anesthesia compared to patients who underwent bilateral tubal ligation with general anesthesia.

  from december 2024 to january 2025

Secondary Outcomes (1)

• Evaluation of patient and surgical satisfaction

  from january 2025 to february 2025

Study Arms (1)

PATIENTS UNDERGOING LAPAROSCOPIC TUBA LIGATION SURGERY

COMPARISON OF PATIENTS UNDERGOING GENERAL AND SPINAL ANESTHESIA AS ANESTHESIA METHODS IN LAPAROSCOPIC TUBE LIGATION SURGERY

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Female Adults Patients

You may qualify if:

• ASA I-II Women aged 18-45 Patients undergoing laparoscopic tubal ligation

You may not qualify if:

• Patients with psychiatric illness, Patients who developed complications during laparoscopy, Patients who converted from spinal anesthesia to general anesthesia

Sponsors & Collaborators

• KADİR TEOMAN: lead
• Ankara City Hospital Bilkent: collaborator

Study Sites (1)

Ankara Etlik City Hospital

Ankara, 06170, Turkey (Türkiye)

Location

Related Publications (2)

• Major AL, Jumaniyazov K, Yusupova S, Jabbarov R, Saidmamatov O, Mayboroda-Major I. Laparoscopy in Gynecologic and Abdominal Surgery in Regional (Spinal, Peridural) Anesthesia, the Utility of the Technique during COVID-19 Pandemic. Medicines (Basel). 2021 Oct 19;8(10):60. doi: 10.3390/medicines8100060.

  PMID: 34677489 RESULT

• Kaya Ugur B, Pirbudak L, Ozturk E, Balat O, Ugur MG. Spinal versus general anesthesia in gynecologic laparoscopy: A prospective, randomized study. Turk J Obstet Gynecol. 2020 Sep;17(3):186-195. doi: 10.4274/tjod.galenos.2020.28928. Epub 2020 Oct 2.

  PMID: 33072423 RESULT

Study Officials

• KADİR TEOMAN ETİKCAN, MEDİCAL DOCTOR

  ANKARA ETLİK CİTY HOSPİTAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Specialist

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: November 29, 2024
• Study Start: December 1, 2024
• Primary Completion: January 10, 2025
• Study Completion: January 15, 2025
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

TU (1)