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OpenTrials
Completed

NCT Number: NCT07035899

Propofol Anesthesia and Perinatal Outcome

The effects of intravenous propofol administration for general anesthesia in cesarean deliveries on maternal and infant health will be evaluated in relation to maternal and umbilical cord blood propofol levels.

Completed

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Haseki Training and Research Hospital

Sultangazi, Istanbul, 34340, Turkey (Türkiye)

About this study

After the ethics committee approval was obtained, volunteers who met the criteria for inclusion in the study were included in the study after obtaining their written permission. After the patients were taken to the operating room, IV catheterization was achieved after CTA, TA and sPO2 monitoring, and the patient was intubated 2 minutes after induction of propfol at 3 mg/kg and rocuronium at 0.6 mg/kg. After the baby was born, an intravenous blood sample was taken from the umbilical cord and the mother simultaneously. After the venous blood samples were obtained as 3 μL, the serum samples obtained by centrifugation as standard were portioned in equal volume to 500 μL Eppendorf tubes and stored at -80°C. After this pre-treatment, propofol was subjected to measurement tests with HPLC, and the collected data were added

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Being pregnant in ASA category 1-2
  • >39 weeks of healthy pregnancy
  • >28 weeks complicated pregnancy
  • Cesarean delivery with or without action
  • Providing induction of general anesthesia with intravenous propofol

Exclusion criteria

  • Pregnant women under the age of 18,
  • Those who have stillbirth,
  • Severe chronic kidney and liver disease,
  • Neurological disease
  • Those with other systemic diseases

Treatment and study plan

Caesarean Section

Drug

Cesarean section was performed as routine surgical procedure

Primary outcomes

  1. Blood propofol concentration

    Time frame: The first 5 minutes of cesarean delivery

    ng/ml

Sponsors and collaborators

Lead sponsor

Haseki Training and Research Hospital

Other

Registry information

Official study title

Association of Maternal and Neonatal Umbilical Cord Blood Levels of Propofol Administered for Induction of General Anesthesia With Perinatal Findings in Gravidas Undergoing Cesarean Section

Acronym: PA-Perinatal-O

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 25, 2025
Registry last updated
Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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