Up-Down Determination of the ED90 of Metaraminol to Treat Hypotension During Cesarean Section
The purpose of this study is to find the best dose of metaraminol to be used in patients during elective cesarean sections.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Up-Down Determination of the ED90 of Metaraminol to Treat Hypotension During Elective Cesarean Section|
- The ED90 of Metaraminol to treat hypotension in elective cesarean section will be determined. [ Time Frame: From spinal induction until delivery (on average 30-60min) ] [ Designated as safety issue: No ]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.
- Maternal Demographics (Age, Height, Weight and Gestational Age) [ Designated as safety issue: No ]
- Incidence of Nausea and Vomiting [ Time Frame: From spinal induction until delivery (on average 30-60min) ] [ Designated as safety issue: No ]
- Time between skin incision and delivery [ Designated as safety issue: No ]
- Time between uterine incision and delivery [ Designated as safety issue: No ]
- Total dose of metaraminol [ Designated as safety issue: No ]
- Number of Participants with Hypertension or Bradycardia as a Measure of Safety and Tolerability [ Time Frame: From spinal induction until delivery (on average 30-60min) ] [ Designated as safety issue: No ]
- Umbilical blood gases
- Fetal well-being with Apgar scores [ Designated as safety issue: No ]
|Study Start Date:||November 2009|
|Study Completion Date:||August 2010|
|Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01108874
|Hospital São Paulo|
|São Paulo, Brazil|
|Principal Investigator:||Jefferson Clivatti, MD||Disciplina de Anestesiologia, UNIFESP|