Comparison of Oxidants and Antioxidants in Breastmilk Under Different Anesthesia Protocols

NCT06811714 | Completed

• 1 other identifier: drozlemersoy6
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to determine in women undergoing cesarean section if total oxidant status and total antioxidant status in breastmilk taken at the 6th hour postoperatively changes between general and regional anesthetic protocols. Researchers will compare general anesthesia and regional anesthesia groups to see if total oxidant status and total antioxidant status in breastmilk taken at the 6th hour postoperatively changes. Participants will provide 2 ml of breastmilk at the 6th postoperative hour.

Conditions

Oxidative Stress

Keywords

oxidative stress; cesarean section; anesthesia, general; anesthesia, regional; breastmilk

Outcome Measures

Primary Outcomes (2)

• Total oxidant status

  Total oxidant status in breastmilk taken at 6th postoperative hour will be measured.

  Postoperative 24 hours

• Total antioxidant status

  Total antioxidant status in breastmilk taken at the 6th postoperative hour will be measured.

  Postoperative 24 hours

Study Arms (2)

General Anesthesia

64 Patients undergoing cesarean section under general anesthesia

Regional Anesthesia

64 Patients undergoing cesarean section under regional anesthesia

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women undergoing elective cesarean section under general or regional anesthesia in operating rooms of Duzce University Health Research Center

You may qualify if:

• Patients undergoing cesarean section under general or regional anesthesia
• Patients in the I and II risk groups, according to the American Society of Anesthesiologists (ASA) classification

You may not qualify if:

• Pregnant women with ASA III and above,
• Pregnant women with gestational DM or hypertension,
• Pregnant women with an indication for Intensive Care Unit (ICU),
• Pregnant women with chronic obstructive pulmonary disease,
• Pregnant women with morbid obesity,
• Pregnant women with a history of liver or kidney disease,
• Pregnant women with coronary artery disease or heart failure,
• Pregnant women with significant anemia (Hg\<7).

Sponsors & Collaborators

• Duzce University: lead

Study Sites (1)

Duzce University

Düzce, Düzce, 81010, Turkey (Türkiye)

Location

Study Officials

• Özlem Ersoy Karka, Ass. Prof.

  Düzce University Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 31, 2025
• First Posted: February 6, 2025
• Study Start: February 6, 2025
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: November 25, 2025

Record last verified: 2025-06

Locations

TU (1)