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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metaraminol | Drug | Patients will be given metaraminol every time SBP falls below baseline value. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From spinal induction until delivery (on average 30-60min) |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal Demographics (Age, Height, Weight and Gestational Age) | ||
| Incidence of Nausea and Vomiting | From spinal induction until delivery (on average 30-60min) | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jefferson Clivatti, MD | Disciplina de Anestesiologia, UNIFESP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital São Paulo | São Paulo | São Paulo | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19162468 | Background | 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. | |
| 17585226 | Background | 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. |
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| ID | Term |
|---|---|
| D007022 | Hypotension |
| D009325 | Nausea |
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D008680 | Metaraminol |
| ID | Term |
|---|---|
| D010665 | Phenylpropanolamine |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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| 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 | From spinal induction until delivery (on average 30-60min) |
| Umbilical blood gases |
| Fetal well-being with Apgar scores |
| 11506099 | Background | 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. |
| 12562407 | Background | 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. |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009930 |
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |