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

Purpose

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

Condition	Intervention	Phase
Hypotension	Drug: Metaraminol	Phase 2

Study Type:	Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: Cesarean Section High Blood Pressure Low Blood Pressure Nausea and Vomiting

U.S. FDA Resources

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	48
Study Start Date:	November 2009
Study Completion Date:	August 2010
Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Intervention Details:

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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01108874

Locations

Brazil
Hospital São Paulo
São Paulo, Brazil

Sponsors and Collaborators

Federal University of São Paulo

Investigators

Principal Investigator:

Jefferson Clivatti, MD

Disciplina de Anestesiologia, UNIFESP

More Information

Publications:

Tanaka M, Balki M, Parkes RK, Carvalho JC. ED95 of phenylephrine to prevent spinal-induced hypotension and/or nausea at elective cesarean delivery. Int J Obstet Anesth. 2009 Apr;18(2):125-30. Epub 2009 Jan 21.

Pace NL, Stylianou MP. Advances in and limitations of up-and-down methodology: a précis of clinical use, study design, and dose estimation in anesthesia research. Anesthesiology. 2007 Jul;107(1):144-52. Review.

Ngan Kee WD, Lau TK, Khaw KS, Lee BB. Comparison of metaraminol and ephedrine infusions for maintaining arterial pressure during spinal anesthesia for elective cesarean section. Anesthesiology. 2001 Aug;95(2):307-13.

Ngan Kee WD, Lee A. Multivariate analysis of factors associated with umbilical arterial pH and standard base excess after Caesarean section under spinal anaesthesia. Anaesthesia. 2003 Feb;58(2):125-30.

Responsible Party:	Jefferson Clivatti, MD, Disciplina de Anestesiologia, Universidade Federal de São Paulo
ClinicalTrials.gov Identifier:	NCT01108874 History of Changes
Other Study ID Numbers:	CEP1241/09
Study First Received:	April 19, 2010
Last Updated:	September 30, 2010
Health Authority:	Brazil: Ethics Committee

Keywords provided by Federal University of São Paulo:

Cesarean section
Hypotension
Metaraminol
Vasoconstrictor Agents
Adult
Female

Pregnancy
Anesthesia, Obstetrical/adverse effects
Anesthesia,Spinal
Blood Pressure/drug effects
Nausea
Vomiting

Additional relevant MeSH terms:

Hypotension
Vascular Diseases
Cardiovascular Diseases
Metaraminol
Vasoconstrictor Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013