Clinical trial NCT06710522: COMPARISON OF OXIDANT-ANTIOXIDANT LEVELS WITH STRESS HORMONES IN SPINAL ANESTHESIA AND GENERAL ANESTHESIA IN LAPAROSCOPIC TUBE LIGATION
Official title: COMPARISON OF OXIDANT-ANTIOXIDANT LEVELS WITH STRESS HORMONES IN SPINAL ANESTHESIA AND GENERAL ANESTHESIA IN LAPAROSCOPIC TUBE LIGATION
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Gynecologic Laparoscopic Surgery
Keywords: spinal anesthesia
general anesthesia
cortisol
acth
native thiol
total thiol
disulfide
Lead sponsor: Ankara Etlik City Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Ankara City Hospital Bilkent
First posted: 2024-11-29
Enrollment: 136
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Female Adults Patients

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.

Eligibility criteria: 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

Primary outcomes:
measure: kortizol-acth levels
timeFrame: from december 2024 to january 2025
measure: oxidant-antioxidan levels
timeFrame: from december 2024 to january 2025
Secondary outcomes:
measure: Evaluation of patient and surgical satisfaction
timeFrame: from january 2025 to february 2025
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Etlik City Hospital
Study officials:
affiliation: ANKARA ETLİK CİTY HOSPİTAL
name: KADİR TEOMAN ETİKCAN, MEDİCAL DOCTOR
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.