CompletedNot Applicable

Comparing Inhalational Anesthesia and TIVA on Maternal and Neonatal Hemodynamics in Elective Cesarean Section

Turkey (Türkiye)80 participantsStarted 2024-03-15

Plain-language summary

This prospective, double-blind, randomized controlled trial compares the effects of total intravenous anesthesia (TIVA) versus sevoflurane-based inhalational anesthesia on maternal hemodynamics, depth of anesthesia, and early neonatal clinical outcomes in pregnant women undergoing elective cesarean section under general anesthesia

Who can participate

Age range21 Years – 41 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Pregnant women scheduled for elective cesarean section under general anesthesia. * Gestational age of 38 weeks or greater. * American Society of Anesthesiologists (ASA) physical status II. Exclusion Criteria: * Emergency cesarean section (Category 1 and 2). * Presence of fetal distress. \* ASA physical status III or higher. * Preference for regional anesthesia. * Antenatally detected fetal anomalies. * Multiple pregnancies. * Estimated birth weight less than 2400 grams. * Known allergy to the study drugs or intraoperative adverse drug reactions. * Severe eclampsia. * Patients requiring conversion to general anesthesia due to inadequate spinal block.

What they're measuring

Depth of Anesthesia Assessed by Bispectral Index (BIS)

Timeframe: During surgery (at 1, 2, 5, 10, 20, 30, 40 minutes and at the end of surgery)

Neonatal Neurologic and Adaptive Capacity Score (NACS)

Timeframe: At 1 minute, 1 hour, and 24 hours post-delivery

Trial details

NCT IDNCT07513870

SponsorMedipol University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-01

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