search
Back to results

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

Primary Purpose

Hypotension

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Metaraminol
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypotension focused on measuring Cesarean section, Hypotension, Metaraminol, Vasoconstrictor Agents, Adult, Female, Pregnancy, Anesthesia, Obstetrical/adverse effects, Anesthesia,Spinal, Blood Pressure/drug effects, Nausea, Vomiting

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Hospital São Paulo

Outcomes

Primary Outcome Measures

The ED90 of Metaraminol to treat hypotension in elective cesarean section will be determined.
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)
Incidence of Nausea and Vomiting
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
Umbilical blood gases
Fetal well-being with Apgar scores

Full Information

First Posted
April 19, 2010
Last Updated
September 30, 2010
Sponsor
Federal University of São Paulo
search

1. Study Identification

Unique Protocol Identification Number
NCT01108874
Brief Title
Up-Down Determination of the ED90 of Metaraminol to Treat Hypotension During Cesarean Section
Official Title
Up-Down Determination of the ED90 of Metaraminol to Treat Hypotension During Elective Cesarean Section
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Federal University of São Paulo

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension
Keywords
Cesarean section, Hypotension, Metaraminol, Vasoconstrictor Agents, Adult, Female, Pregnancy, Anesthesia, Obstetrical/adverse effects, Anesthesia,Spinal, Blood Pressure/drug effects, Nausea, Vomiting

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Metaraminol
Intervention Description
Patients will be given metaraminol every time SBP falls below baseline value.
Primary Outcome Measure Information:
Title
The ED90 of Metaraminol to treat hypotension in elective cesarean section will be determined.
Description
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.
Time Frame
From spinal induction until delivery (on average 30-60min)
Secondary Outcome Measure Information:
Title
Maternal Demographics (Age, Height, Weight and Gestational Age)
Title
Incidence of Nausea and Vomiting
Time Frame
From spinal induction until delivery (on average 30-60min)
Title
Time between skin incision and delivery
Title
Time between uterine incision and delivery
Title
Total dose of metaraminol
Title
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)
Title
Umbilical blood gases
Title
Fetal well-being with Apgar scores

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jefferson Clivatti, MD
Organizational Affiliation
Disciplina de Anestesiologia, UNIFESP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital São Paulo
City
São Paulo
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
19162468
Citation
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. doi: 10.1016/j.ijoa.2008.09.008. Epub 2009 Jan 21.
Results Reference
background
PubMed Identifier
17585226
Citation
Pace NL, Stylianou MP. Advances in and limitations of up-and-down methodology: a precis of clinical use, study design, and dose estimation in anesthesia research. Anesthesiology. 2007 Jul;107(1):144-52. doi: 10.1097/01.anes.0000267514.42592.2a.
Results Reference
background
PubMed Identifier
11506099
Citation
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. doi: 10.1097/00000542-200108000-00009.
Results Reference
background
PubMed Identifier
12562407
Citation
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. doi: 10.1046/j.1365-2044.2003.02888.x.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs