- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04556370
Norepinephrine Prophylaxis for Postspinal Anesthesia Hypotension in Parturients With Preeclampsia.
June 9, 2023 updated by: General Hospital of Ningxia Medical University
Norepinephrine Prophylaxis for Postspinal Anesthesia Hypotension in Parturients With Preeclampsia Undergoing Cesarean Section: a Randomized, Placebo-controlled Dose-finding Trial
The purpose of this study is to investigate the suitable infusion dose of norepinephrine for prophylaxis against postspinal anesthesia hypotension in parturients with preeclampsia undergoing cesarean section.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Preeclampsia, which affects 5% to 7% of parturients, is a significant cause of maternal and neonatal morbidity and mortality.
Because of constricted myometrial spiral arteries with exaggerated vasomotor responsiveness, though blood pressure in parturients with preeclampsia are apparently higher than healthy parturients, placental hypoperfusion is more common.
Spinal anesthesia is still the preferred mode of anesthesia in parturients with preeclampsia for cesarean section.
In preeclampsia parturients, spinal anesthesia improve intervillous blood flow (provided that hypotension is avoided) which contribute to increase placental perfusion.
Even so, 17-26% parturients with preeclampsia experienced postspinal anesthesia hypotension due to the extensive sympathetic block that occurred with spinal anesthesia.
As a potential substitute drug for phenylephrine and ephedrine, norepinephrine has gained traction for use in parturients undergoing cesarean section.
But the suitable infusion dose of norepinephrine in parturients with preeclampsia is still unknown.
The purpose of this study is to investigate the suitable infusion dose of norepinephrine for prophylaxis against post-spinal anesthesia hypotension in parturients with preeclampsia undergoing cesarean section.
Study Type
Interventional
Enrollment (Actual)
180
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ningxia
-
Yinchuan, Ningxia, China, 75004
- General Hospital of Ningxia Medical University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 18-45 years
- Primipara or multipara
- Singleton pregnancy ≥32 weeks
- American Society of Anesthesiologists physical status classification II to III
- Scheduled for cesarean section under spinal anesthesia
Exclusion Criteria:
- Baseline blood pressure ≥180 mmHg
- Body height < 150 cm
- Body weight > 100 kg or body mass index (BMI) ≥ 40 kg/m2
- Eclampsia or chronic hypertension
- Hemoglobin < 7g/dl
- Fetal distress, or known fetal developmental anomaly
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Control group
Normal saline infusion simultaneous with subarachnoid block
|
Normal saline infusion simultaneous with subarachnoid block
Other Names:
|
Experimental: 0.025 μg/kg/min group
A maintenance dose of norepinephrine (0.025 μg/kg/min) infusion simultaneous with subarachnoid block
|
Different infusion dose of norepinephrine simultaneous with subarachnoid block
Other Names:
|
Experimental: 0.050 μg/kg/min group
A maintenance dose of norepinephrine (0.050 μg/kg/min) infusion simultaneous with subarachnoid block
|
Different infusion dose of norepinephrine simultaneous with subarachnoid block
Other Names:
|
Experimental: 0.075 μg/kg/min group
A maintenance dose of norepinephrine (0.075 μg/kg/min) infusion simultaneous with subarachnoid block
|
Different infusion dose of norepinephrine simultaneous with subarachnoid block
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The incidence of post-spinal anesthesia hypotension
Time Frame: 1-15 minutes after spinal anesthesia.
|
Systolic blood pressure (SBP) < 80% of the baseline
|
1-15 minutes after spinal anesthesia.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The incidence of hypertension.
Time Frame: 1-15 minutes after spinal anesthesia
|
Systolic blood pressure (SBP) >120% of the baseline.
|
1-15 minutes after spinal anesthesia
|
Overall stability of systolic blood pressure control versus baseline
Time Frame: 1-15 minutes after spinal anesthesia
|
Evaluated by performance error (PE)
|
1-15 minutes after spinal anesthesia
|
Overall stability of heart rate control versus baseline
Time Frame: 1-15 minutes after spinal anesthesia
|
Evaluated by performance error (PE)
|
1-15 minutes after spinal anesthesia
|
The incidence of severe post-spinal anesthesia hypotension
Time Frame: 1-15 minutes after spinal anesthesia
|
Systolic blood pressure (SBP) < 60% of the baseline
|
1-15 minutes after spinal anesthesia
|
The incidence of nausea and vomiting
Time Frame: 1-15 minutes after spinal anesthesia
|
Presence of nausea and vomiting in patients after spinal anesthesia
|
1-15 minutes after spinal anesthesia
|
pH
Time Frame: Immediately after delivery
|
From umbilical arterial blood gases.
|
Immediately after delivery
|
Partial pressure of oxygen
Time Frame: Immediately after delivery
|
From umbilical arterial blood gases.
|
Immediately after delivery
|
Base excess
Time Frame: Immediately after delivery
|
From umbilical arterial blood gases.
|
Immediately after delivery
|
APGAR score
Time Frame: 1 min after delivery
|
A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration
|
1 min after delivery
|
APGAR score
Time Frame: 5 min after delivery
|
A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration
|
5 min after delivery
|
The incidence of bradycardia
Time Frame: 1-15 minutes after spinal anesthesia
|
Heart rate < 55 beats/min
|
1-15 minutes after spinal anesthesia
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Yi Chen, M.D., General Hospital of Ningxia Medical University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 16, 2021
Primary Completion (Actual)
June 6, 2023
Study Completion (Actual)
June 6, 2023
Study Registration Dates
First Submitted
September 15, 2020
First Submitted That Met QC Criteria
September 15, 2020
First Posted (Actual)
September 21, 2020
Study Record Updates
Last Update Posted (Actual)
June 13, 2023
Last Update Submitted That Met QC Criteria
June 9, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Pregnancy Complications
- Hypertension, Pregnancy-Induced
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Hypotension
- Pre-Eclampsia
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Sympathomimetics
- Vasoconstrictor Agents
- Norepinephrine
Other Study ID Numbers
- Yi Chen-2020-5
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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