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

NCT ID: NCT01108874

Last Updated: 2010-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Hypotension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Interventions

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Metaraminol

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Disciplina de Anestesiologia, Universidade Federal de São Paulo

Principal Investigators

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Jefferson Clivatti, MD

Role: PRINCIPAL_INVESTIGATOR

Disciplina de Anestesiologia, UNIFESP

Locations

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Hospital São Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type BACKGROUND
PMID: 19162468 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17585226 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11506099 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12562407 (View on PubMed)

Other Identifiers

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CEP1241/09

Identifier Type: -

Identifier Source: org_study_id