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Clinical Trials/NCT06710522
NCT06710522Enrolling By InvitationNot Applicable

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

KADİR TEOMAN1 site in 1 country136 target enrollmentStarted: December 1, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Enrolling By Invitation
Sponsor
Enrollment
136
Locations
1
Primary Endpoint
kortizol-acth levels

Study Overview

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

Detailed Description

Laparoscopic procedures are usually performed as day surgery. General and regional anesthesia; It is used successfully and safely when care is taken in the use of short-acting drugs, ensuring cardiovascular stability, rapid recovery and mobilization, postoperative nausea, vomiting and pain treatment.

Although the common procedure in laparoscopic surgeries is surgery under general anesthesia, it has been reported that regional anesthesia methods can be used safely within certain limits.

Regional anesthesia; It is advantageous due to rapid recovery, less nausea and vomiting and postoperative pain, short hospitalization, reduced cost, increased patient satisfaction, early diagnosis of complications and less hemodynamic changes. General anesthesia complications such as sore throat, muscle pain and airway trauma are not observed.

There are some limitations when regional anesthesia methods are applied in laparoscopic surgeries. Problems in the operating room cause the patient's anxiety, pain and discomfort to increase, causing the need for intravenous sedation support. Pneumoperitoneum effect may cause sedation, hypoventilation and decrease in arterial oxygen saturation.

One of the indications for regional anesthesia is laparoscopic tubal ligation. Procedures requiring many puncture points, important organ manipulations, steep inclination of the operating table, development of pneumoperitoneum make it difficult for the patient to breathe spontaneously and regional anesthesia should not be applied in these cases.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

kortizol-acth levels

Time Frame: from december 2024 to january 2025

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.

oxidant-antioxidan levels

Time Frame: from december 2024 to january 2025

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.

Secondary Outcomes

  • Evaluation of patient and surgical satisfaction(from january 2025 to february 2025)

Investigators

Sponsor
KADİR TEOMAN
Sponsor Class
Other Gov
Responsible Party
Sponsor Investigator
Principal Investigator

KADİR TEOMAN

Specialist

Ankara Etlik City Hospital

Study Sites (1)

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