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

• Conditions: Gynecologic Laparoscopic Surgery

• Registration Number: NCT06710522
• Lead Sponsor: KADİR TEOMAN

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.

Spinal anesthesia is the simplest and most reliable regional anesthesia technique. Spinal anesthesia, which is a primary technique for laparoscopic gynecology, has many advantages over general anesthesia.

The patient position depends on the area to be operated on. In gynecological procedures, the Trendelenburg position is applied for the pelvic organs. In laparoscopic surgeries, the operator must be experienced in order to apply spinal anesthesia. Trendelenburg position may cause spinal block to spread to the head, increase sympathetic block, bradycardia and hypotension. In rare cases, intubation material and general anesthesia devices should be immediately available to ensure deep hypotension and respiratory continuity.

Regional anesthesia has advantages such as minimal effect on the respiratory system and prevention of the spread of pathogens related to intubation to the lower respiratory system.

Reduced thromboembolic complications and reduced surgical stress response. By using regional anesthesia techniques, aerosol-generating procedures can be avoided with less risk for healthcare personnel.

Low-dose spinal anesthesia is a good alternative to general anesthesia with desflurane in outpatient gynecological surgeries. Postoperative pain and cost are less in spinal anesthesia, while recovery is faster. When compared to general anesthesia with propofol total intravenous infusion, recovery time was found to be shorter in low-dose spinal anesthesia. With the development of gasless laparoscopy and microlaparoscopy techniques, the place of spinal anesthesia in laparoscopies will increase over time.

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-26
• Study First Submitted QC: 2024-11-26
• Last Update Submitted: 2024-11-26
• Study First Posted: 2024-11-29
• Last Update Posted: 2024-11-29
• Study Start: 2024-12-01
• Primary Completion: 2025-01-10
• Study Completion: 2025-01-15

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 136

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
kortizol-acth levels	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	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 Outcome Measures

Name	Time	Method
Evaluation of patient and surgical satisfaction	from january 2025 to february 2025	Evaluation of patient and surgical satisfaction in patients undergoing bilateral tubal ligation with spinal anesthesia and in patients undergoing bilateral tubal ligation with general anesthesia

Trial Locations

Locations (1)

Ankara Etlik City Hospital; 🇹🇷 Ankara, Turkey