Clinical trial NCT06206928: Evaluation of Mitochondrial Enzyme Activity in Cesarean Section Patients
Official title: Investigation of Trace Element Metabolism and Tricarboxylic Acid Cycle Enzyme Activities in Patients Who Underwent Cesarean Section With Spinal Anesthesia
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cesarean Section
Spinal Anesthesia
Thiol Groups
Keywords: cesarean section
spinal anesthesia
mitochondrial enzyme changes
thiol disulfide balance
Lead sponsor: Sanliurfa Mehmet Akif Inan Education and Research Hospital
Sponsor class: OTHER
First posted: 2024-01-16
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who will undergo planned cesarean section between the ages of 18 and 40

Brief summary: The goal of this observational study is to learn about in effects of trace element metabolism, tricarboxylic acid cycle enzyme activities and thiol/disulfide balance in patients who underwent cesarean section under spinal anesthesia. The main question\[s\] it aims to answer are:

• What is the effect of trace element metabolism, tricarboxylic acid cycle enzyme activities and thiol/disulfide balance in patients undergoing cesarean section under regional anesthesia? A 10 ml blood sample will be taken from the participants to analyze the biochemical parameters mentioned before and after the operation. Pre- and post-operative values will be compared.

Detailed description: Although the World Health Organization recommends the cesarean birth rate as 10-15%, the cesarean birth rate in Turkey is 57.3% according to 2020 data, ranking first in the world. This rate is around 30% for primary cesarean delivery. Although there are various methods of anesthesia for cesarean birth, spinal block is a regional anesthesia method frequently used in elective cesarean births because it is easy to apply, has a rapid onset of effect and provides a good sensory block. With this anesthesia method, local anesthetic solution is administered to the subarachnoid space to create sensory and motor block within the surgical area.

Although trace elements (Zinc (Zn), Iron (Fe), Copper (Cu)) constitute a small part of the human body, they play a very important role in maintaining normal metabolic function. Deficiency or excess of these elements causes dysfunction of the relevant enzymes (such as alcohol dehydrogenase, alkaline phosphatase, lactate dehydrogenase, carboxypeptidase, carbonic anhydrase, superoxide dismutase (SOD), DNA and RNA polymerase) and thus various clinical findings (postpartum hemorrhage, fetal growth restriction). FGR), fetal malformations, premature birth, preeclampsia).

In recent years, it has been revealed that thiol-disulfide homeostasis may be an important biomarker of oxidative stress. Thiol is a compound containing sulfhydryl group (-SH) that plays an important role in preventing oxidative stress in cells. Thiols are not only a redox buffer in the body but also an essential element of the antioxidant defense system. Abnormal thiol-disulfide balance levels are associated with oxidative stress. There is a balance between oxidative stress and antioxidant defense mechanisms. The changes in this balance depending on many factors are frequently investigated in patients undergoing surgery.

This study aimed to contribute to the literature by investigating the effects of trace element metabolism, tricarboxylic acid cycle enzyme activities and thiol/disulfide balance in patients who underwent cesarean section under spinal anesthesia.

Eligibility criteria: Inclusion Criteria:

1. Patients who will undergo planned cesarean section between the ages of 18 and 40
2. ASA 1-2 Patients

Exclusion Criteria:

1. Patients who refuse to participate in the study
2. Patients over 40 years of age
3. ASA 3-4 Patients
4. Patients who underwent emergency cesarean section
5. Those with known liver and kidney diseases, patients diagnosed with Diabetes Mellitus
6. Pregnant women diagnosed with an abnormal baby
7. Patients diagnosed with preeclampsia
8. Patients with body mass index ≥ 30
9. Patients who do not accept spinal anesthesia or have contraindications to the application -

Primary outcomes:
measure: Biochemical parameter measurements that we mentioned in the description
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Şanlıurfa
country: Turkey
facility: Şanlıurfa Training and Research Hospital
Study officials:
affiliation: University of Health science
name: MEHMET TERCAN, Assoc Prof
role: PRINCIPAL_INVESTIGATOR
References: