Up-Down Determination of the ED90 of Metaraminol to Treat Hypotension During Cesarean Section

Phase 2

Completed

• Conditions: Hypotension

• Registration Number: NCT01108874
• Lead Sponsor: Federal University of São Paulo

Brief Summary

The purpose of this study is to find the best dose of metaraminol to be used in patients during elective cesarean sections.

Detailed Description

The purpose of this study is to determine the effective dose 90% (ED90) of metaraminol to treat hypotension after spinal anesthesia in elective cesarean sections (CS). It is a double-blind study that uses the biased-coin up-down sequential allocation method to determine the ED90 of metaraminol.

Baseline systolic blood pressure (SBP) will be determined by three automated measures 3 minutes apart just before CS. During the period from induction of spinal anesthesia to fetal delivery SBP will be monitored every minute and metaraminol will be administered every time it is lower than baseline value. If SBP falls below 80% of baseline value, the treatment will be considered a failure. An adequate response will be defined as the absence of hypotension during the study period.

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2010-04-19
• Study First Submitted QC: 2010-04-21
• Study First Posted: 2010-04-22
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-30
• Last Update Posted: 2010-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 48

Inclusion Criteria

• Elective CS under spinal anesthesia
• Normal singleton pregnancy beyond 36 weeks gestation
• ASA physical status I/II
• Age over 18 years

Exclusion Criteria

• Patient refusal
• Allergy to metaraminol
• Preexisting or pregnancy-induced hypertension
• Cardiovascular or cerebrovascular disease
• Fetal abnormalities

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The ED90 of Metaraminol to treat hypotension in elective cesarean section will be determined.	From spinal induction until delivery (on average 30-60min)	Bolus doses of metaraminol will be used every time SBP falls below baseline values and maternal responses to doses will be used to build a dose response curve from where ED90 will be estimated.

Secondary Outcome Measures

Name	Time	Method
Maternal Demographics (Age, Height, Weight and Gestational Age)
Incidence of Nausea and Vomiting	From spinal induction until delivery (on average 30-60min)
Time between skin incision and delivery
Time between uterine incision and delivery
Total dose of metaraminol
Number of Participants with Hypertension or Bradycardia as a Measure of Safety and Tolerability	From spinal induction until delivery (on average 30-60min)
Umbilical blood gases
Fetal well-being with Apgar scores

Trial Locations

Locations (1)

Hospital São Paulo; 🇧🇷 São Paulo, Brazil