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Sponsored by: |
Samuel Lunenfeld Research Institute, Mount Sinai Hospital |
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Information provided by: | Samuel Lunenfeld Research Institute, Mount Sinai Hospital |
ClinicalTrials.gov Identifier: | NCT00379691 |
The purpose of this study is to determine the minimum effective bolus dose of phenylephrine to prevent post-spinal hypotension in Cesarean section in 95
Condition | Intervention |
---|---|
Hypotension Nausea |
Drug: phenylephrine |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Dose Comparison, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phenylephrine Dose-Finding Study to Minimize Hypotension Due to Spinal Anesthesia for Cesarean Section |
Estimated Enrollment: | 50 |
Study Start Date: | August 2006 |
Study Completion Date: | December 2006 |
The purpose of this study is to determine the minimum effective bolus dose of phenylephrine to prevent post-spinal hypotension in CS in 95 % of our patients. The study will be conducted in a randomized double-blinded fashion. This dose-response study will be conducted as per the up-down sequential allocation method, modified by the Narayana rule, designed to cluster the results around the ED95.
Blood pressure will be monitored every minute from intrathecal injection to the delivery of the child. Phenylephrine will be administered every time the blood pressure is equal to or lower than the control value.Hypotension will be defined as a SBP less than 80 % of the baseline value, in which case the treatment will be a failure. Hypertension will be defined as a SBP more than 120 % of baseline value. If a patient presents hypertension for two consecutive measurements, the case will be considered a drop out.An adequate response will be defined as the absence of hypotension or nausea/vomiting during the period from induction of spinal anesthesia to uterine incision prior to fetal delivery.
The results of this study will define the minimum effective dose of phenylephrine to prevent post-spinal hypotension and nausea/vomiting secondary to hypotension in Cesarean section, thus optimizing the safety profile with respect to maternal and fetal side effects of this vasopressor.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Canada, Ontario | |
Mount Sinai Hospital | |
Toronto, Ontario, Canada, M5G 1X5 |
Principal Investigator: | Jose CA Carvalho, MD PhD | Department of Anesthesia and Pain Management, Mount Sinai Hospital, University of Toronto |
Study ID Numbers: | 06-01, 06-0186-E |
Study First Received: | September 21, 2006 |
Last Updated: | March 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00379691 History of Changes |
Health Authority: | Canada: Ethics Review Committee |
spinal Cesarean section hypotension |
nausea vomiting phenylephrine |
Pseudoephedrine Hypotension Neurotransmitter Agents Vomiting Adrenergic alpha-Agonists Adrenergic Agents Vascular Diseases Anesthetics Cardiovascular Agents Adrenergic Agonists |
Nasal Decongestants Signs and Symptoms Oxymetazoline Mydriatics Phenylephrine Vasoconstrictor Agents Ephedrine Nausea Peripheral Nervous System Agents |
Hypotension Respiratory System Agents Neurotransmitter Agents Adrenergic alpha-Agonists Adrenergic Agents Molecular Mechanisms of Pharmacological Action Sympathomimetics Cardiotonic Agents Physiological Effects of Drugs Vascular Diseases Cardiovascular Agents Protective Agents |
Adrenergic Agonists Pharmacologic Actions Nasal Decongestants Oxymetazoline Mydriatics Autonomic Agents Phenylephrine Therapeutic Uses Vasoconstrictor Agents Cardiovascular Diseases Peripheral Nervous System Agents |