Propofol Anesthesia and Perinatal Outcome (PA-Perinatal-O)

Haseki Training and Research Hospital

Status: Completed

Conditions: Pregnancy Complications; Anesthesia

Treatments: Drug: Caesarean Section

Study type: Interventional

Funder types: Other

Identifiers

NCT07035899

PA-PN-O2024

Details and patient eligibility

About

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.

Full description

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

Enrollment: 102 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

102 participants in 2 patient groups

Women with Healthy Pregnance undergone Caesarean Section

Sham Comparator group

Description:

Healthy Pregnant Women between the ages of 18 and 40

Treatment:

Drug: Caesarean Section

Women Compliceted Pregnance undergone Caesarean Section

Active Comparator group

Description:

Pregnant women between the ages of 18-40 with Pearclampsia, Preterm Labor, Fetal Growth Retardation, Gestational Diabetes

Treatment:

Drug: Caesarean Section