Hypotension Clinical Trial
Official title:
Norepinephrine To Prevent Hypotension After Spinal Anesthesia For Cesarean Delivery: A Dose Finding Study
Spinal anesthesia is the most common anesthetic technique for elective Cesarean delivery
(CD), but the most frequent unwanted side effect is hypotension, which can cause nausea and
vomiting, as well as effects on the fetus. Prevention and treatment of maternal hypotension
includes intravenous fluids and vasopressors. Phenylephrine is the most common vasopressor
used for this purpose. However, it has been shown to reduce maternal heart rate and cardiac
output, which may be a concern in an already compromised fetus. Norepinephrine is commonly
used in high concentrations in intensive care and recent studies have suggested that in low
concentrations it may be a better alternative to phenylephrine in elective CD, as it does
not reduce the maternal heart rate or cardiac output. The optimum bolus dose of
norepinephrine to prevent hypotension after spinal anesthesia in elective CD has not been
elucidated. The investigators propose this study to determine the dose that would be
effective in 90% of patients (ED90).
A previous study by Ngan Kee et al, using continuous infusion of norepinephrine to prevent
hypotension in elective CD, suggested a potency ratio for norepinephrine to phenylephrine of
approximately 16:1. Hence, the investigators hypothesise that the ED90 will be approximately
6 µg, given that the current phenylephrine bolus dose at the investigators' institution is
approximately 100 µg.
Status | Completed |
Enrollment | 40 |
Est. completion date | April 2016 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: - Elective CD under spinal anesthesia - Normal singleton pregnancy beyond 36 weeks gestation - ASA physical status II/III - Weight 50-100 kg, height 150-180 cm - Age over 18 years - Informed consent Exclusion Criteria: - Patient refusal - Allergy or hypersensitivity to norepinephrine or sulfite - Preexisting or pregnancy-induced hypertension - Cardiovascular or cerebrovascular disease - Fetal abnormalities - History of diabetes, excluding gestational diabetes - Use of monoamine oxidase inhibitors, triptyline or imipramine antidepressants |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Mount Sinai Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Samuel Lunenfeld Research Institute, Mount Sinai Hospital |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Systolic blood pressure | The primary outcome of this study will be the success/response of the norepinephrine dose to maintain the systolic blood pressure at or above 80% of baseline, from induction of spinal anesthesia to delivery of the fetus. | 30 minutes | Yes |
Secondary | Presence of Nausea | Presence of nausea in patients from induction of spinal anesthesia to delivery of the fetus. | 30 minutes | No |
Secondary | Presence of Vomiting | Presence of vomiting in patients from induction of spinal anesthesia to delivery of the fetus. | 30 minutes | No |
Secondary | Hypertension: Systolic blood pressure at or above 120% of baseline | Systolic blood pressure at or above 120% of baseline, from induction of spinal anesthesia to delivery of the fetus. | 30 minutes | Yes |
Secondary | Bradycardia: Heart rate less than 50 bpm | Heart rate less than 50 bpm, from induction of spinal anesthesia | 30 minutes | Yes |
Secondary | Upper sensory level of anesthetic block, assessed by pinprick upon delivery | Upper sensory level of anesthesia, assessed by pinprick upon delivery | 30 minutes | No |
Secondary | Umbilical artery pH | Umbilical artery pH | 24 hours | No |
Secondary | Umbilical artery partial pressure of carbon dioxide | Umbilical artery partial pressure of carbon dioxide | 24 hours | No |
Secondary | Umbilical artery partial pressure of oxygen | Umbilical artery partial pressure of oxygen | 24 hours | No |
Secondary | Umbilical artery bicarbonate | Umbilical artery bicarbonate | 24 hours | No |
Secondary | Umbilical artery base excess | Umbilical artery base excess | 24 hours | No |
Secondary | Umbilical vein pH | Umbilical vein pH | 24 hours | No |
Secondary | Umbilical vein partial pressure of carbon dioxide | Umbilical vein partial pressure of carbon dioxide | 24 hours | No |
Secondary | Umbilical vein partial pressure of oxygen | Umbilical vein partial pressure of oxygen | 24 hours | No |
Secondary | Umbilical vein bicarbonate | Umbilical vein bicarbonate | 24 hours | No |
Secondary | Umbilical vein base excess | Umbilical vein base excess | 24 hours | No |
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