eonatal effects after vasopressor during spinal anesthesia for cesarean section: a multicenter, randomized controlled trial

Completed

• Conditions: Hypotension during spinal anesthesia for cesarean section; ephedrine; phenylephrine; spinal anesthesia; cesarean section

• Registration Number: TCTR20150609004
• Lead Sponsor: Ratchadapiseksompotch Fund, Faculty of Medicine

Brief Summary

Ephedrine, compared to phenylephrine as a vasopressor during cesarean delivery, was associated with higher neonatal heart rate in the early post-birth period, but without a significant difference in clinical outcomes in uncomplicated pregnancies.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-09
• Study Completion: 2016-12-31
• Results First Posted: 2017-11-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

ASA I,II
more than 18 years old
Normal singleton baby
GA 37-42 weeks
Adequate spinal anesthesia for cesarean delivery and SBP< 80% of baseline SBP at ward

Exclusion Criteria

PIH, Preexisting hypertension
Complicated obstetrics (eg.Abruptio placenta, placenta previa)
Substance abuse in pregnancy
24 hr. preop. administration of pseudoephedrine, nasal decongestants, pethidine, terbutaline
Known fetal abnormalities (IUGR, fetal cardiac disease)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
neonatal heart rate at 30 minutes post-delivery beat per minute

Secondary Outcome Measures

Name	Time	Method
neonatal blood pressure, respiratory rate, temperature, sugar, lactate, Apgar score at 30 minutes post-delivery mmHg, per miute, degree celcius, mg/l, mmol/l, score