Vasopressors for Low Blood Pressure
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests different medications to manage low blood pressure during cesarean deliveries. Researchers compare ephedrine (a type of vasopressor), phenylephrine, norepinephrine, and vasopressin to determine which is most effective without harming the mother or baby. The goal is to understand how these drugs affect blood flow to the uterus and placenta, which is crucial for the baby's health. Women scheduled for a planned cesarean delivery and not in labor might be suitable for the trial. As an unphased trial, this study allows participants to contribute to important research that could improve outcomes for mothers and babies during cesarean deliveries.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Studies have shown that phenylephrine improves the baby's acid-base balance more effectively than ephedrine, leading to its more common use in managing blood pressure during cesarean deliveries. Norepinephrine, a newer option, maintains the mother's heart function more stably than phenylephrine.
Research suggests that vasopressin can safely stabilize blood pressure in certain situations, though it is not often used in childbirth. However, past reports have shown its successful use in treating low blood pressure after spinal anesthesia without harming mothers or babies.
Each of these medications—ephedrine, phenylephrine, norepinephrine, and vasopressin—has been studied for efficacy and safety. This ongoing research aids doctors in selecting the best option for managing low blood pressure during cesarean deliveries.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these vasopressors because they are exploring how different drugs can manage low blood pressure in a more targeted way. Most standard treatments work by broadly increasing blood pressure, but these drugs—like vasopressin, ephedrine, norepinephrine, and phenylephrine—are being tested for their specific effects on various blood vessels and tissues. Vasopressin, for example, may offer a unique mechanism by directly affecting blood vessel constriction, which could lead to more precise control of blood pressure. By understanding how each drug works in different vascular tissues, this trial could lead to more personalized and effective treatment strategies for individuals with low blood pressure.
What evidence suggests that this trial's treatments could be effective for hypotension during cesarean deliveries?
Research has shown that several medications, known as vasopressors, manage low blood pressure during cesarean deliveries. This trial studies different vasopressors in separate treatment arms. Ephedrine, one of the vasopressors under study, effectively raises blood pressure during general anesthesia, even in older adults. However, studies have found that phenylephrine, another vasopressor being tested, leads to better outcomes for the baby compared to ephedrine, making it a popular choice for cesarean deliveries. Norepinephrine, also part of this trial, effectively maintains the mother's heart function better than phenylephrine. Lastly, vasopressin, which is also being evaluated, may stabilize blood pressure when other treatments fail, but more research is needed to understand its use during cesarean deliveries. Each vasopressor works differently and may offer benefits depending on the patient's specific needs.16789
Who Is on the Research Team?
Mrinalini Balki, MD
Principal Investigator
MOUNT SINAI HOSPITAL
Are You a Good Fit for This Trial?
This trial is for non-laboring patients aged 19-40, undergoing elective primary or first repeat cesarean delivery under spinal anesthesia at a gestational age of 37-41 weeks. They must consent to participate and not have had previous uterine surgery beyond one cesarean, nor be on medications affecting myometrial contractility.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
In-vitro Experimentation
Myometrial and umbilical vessel samples are exposed to various vasopressors to study contractility effects
Data Analysis
Analysis of contraction frequency, amplitude, and motility index from the in-vitro experiments
Follow-up
Review and interpretation of results to assess implications for clinical practice
What Are the Treatments Tested in This Trial?
Interventions
- Ephedrine
- Norepinephrine
- Phenylephrine
- Vasopressin
Trial Overview
The study tests the effects of vasopressors—Ephedrine, Phenylephrine, Norepinephrine, and Vasopressin—on the muscle contractions of the uterus (myometrium) and umbilical vessels in vitro. It aims to understand how these drugs can manage low blood pressure during cesarean deliveries without harming mother or baby.
How Is the Trial Designed?
12
Treatment groups
Experimental Treatment
The umbilical vein samples are bathed in physiological salt solution (PSS) with increasing concentrations of vasopressin
The umbilical vein samples are bathed in physiological salt solution (PSS) with increasing concentrations of phenylephrine
The umbilical vein samples are bathed in physiological salt solution (PSS) with increasing concentrations of norepinephrine
The umbilical vein samples are bathed in physiological salt solution (PSS) with increasing concentrations of ephedrine
The umbilical artery samples are bathed in physiological salt solution (PSS) with increasing concentrations of vasopressin
The umbilical artery samples are bathed in physiological salt solution (PSS) with increasing concentrations of phenylephrine
The umbilical artery samples are bathed in physiological salt solution (PSS) with increasing concentrations of norepinephrine
The umbilical artery samples are bathed in physiological salt solution (PSS) with increasing concentrations of ephedrine
The myometrial samples are bathed in physiological salt solution (PSS) with increasing concentrations of vasopressin
The myometrial samples are bathed in physiological salt solution (PSS) with increasing concentrations of phenylephrine
The myometrial samples are bathed in physiological salt solution (PSS) with increasing concentrations of norepinephrine
The myometrial samples are bathed in physiological salt solution (PSS) with increasing concentrations of ephedrine
Ephedrine is already approved in United States, Canada for the following indications:
- Hypotension
- Bronchial asthma
- Narcolepsy
- Myasthenia gravis
- Allergic disorders
- Nasal decongestant
- Asthma
- Bronchitis
Find a Clinic Near You
Who Is Running the Clinical Trial?
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Lead Sponsor
Citations
Hemodynamic impact of ephedrine on hypotension during ...
These findings suggest that ephedrine is effective for the correction of hypotension during general anesthesia, even in elderly patients.
Effective dose of ephedrine for treatment of hypotension ...
The optimal dose of ephedrine to return mean blood pressure to >80% of baseline was 1.2 mg kg −1 iv, which did not induce adverse events.
208289Orig1s000
efficacy, ephedrine's ability to increase blood pressure did not appear markedly different in those receiving general anesthesia compared to ...
Ephedrine - StatPearls - NCBI Bookshelf - NIH
Ephedrine is a medication used to manage and treat clinically significant hypotension. It is in the sympathomimetic class of drugs.
a prospective cohort study on middle-aged and older patients
Results The administration of ephedrine significantly increased MAP (p < 0.001, mean difference: 8.34 [95% confidence interval (CI), 5.95–10.75] ...
Akovaz, Corphedra (ephedrine) dosing, indications, ...
Medscape - Hypotension dosing for Akovaz, Corphedra (ephedrine), frequency-based adverse effects, comprehensive interactions, contraindications, ...
akovaz - accessdata.fda.gov
Data indicate that repeated administration of ephedrine can result in tachyphylaxis. Clinicians treating anesthesia-induced hypotension with AKOVAZ (ephedrine ...
Ephedrine: Uses, Interactions, Mechanism of Action
Ephedrine increases blood pressure by stimulating heart rate and cardiac output and variably increasing peripheral resistance. It causes bronchodilation due to ...
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