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Completed

NCT Number: NCT01108874

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.

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Key information

Conditions

Hypotension Cardiovascular Diseases Nausea Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vascular Diseases Vomiting

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Hospital São Paulo

São Paulo, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

metaraminol

Drug

Patients will be given metaraminol every time SBP falls below baseline value.

Primary outcomes

  1. 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)

    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 outcomes

  1. Maternal Demographics (Age, Height, Weight and Gestational Age)

  2. Incidence of Nausea and Vomiting

    Time frame: From spinal induction until delivery (on average 30-60min)

  3. Time between skin incision and delivery

  4. Time between uterine incision and delivery

  5. Total dose of metaraminol

  6. 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)

  7. Umbilical blood gases

  8. Fetal well-being with Apgar scores

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Apr 22, 2010
Registry last updated
Oct 1, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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