- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06151496
Intensive Versus Standard Treatment for Spinal Anesthesia-induced Hypotension on Maternal Hemodynamics
November 28, 2023 updated by: General Hospital of Ningxia Medical University
Intensive Versus Standard Treatment for Spinal Anesthesia-induced Hypotension on Maternal Hemodynamics During Cesarean Section: A Multicenter, Prospective, Single-blind, Randomized, Controlled Trial
The objective of this study is to investigate the impact of varying maternal blood pressure maintenance targets on maternal hemodynamics following cesarean section.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Post-spinal anesthesia hypotension is a frequent complication during spinal anesthesia for cesarean section.
The incidence of post-spinal anesthesia hypotension is as high as 62.1-89.7%
if prophylactic measures are not taken.
The 2016 ASA guidelines for obstetric anesthesia suggest avoiding hypotension following spinal anesthesia in women and emphasize the use of vasopressors, specifically alpha-receptor agonists, as the preferred strategy to prevent and manage post-spinal anesthesia hypotension.
The 2018 International Consensus in the United Kingdom and Northern Ireland recommends maintaining maternal systolic blood pressure above 90% of the baseline value following lumbar anesthesia, while avoiding dropping below 80% of the baseline value.
Currently, the threshold for maintaining blood pressure above 80% of the baseline value is widely adopted as a standard; however, limited evidence supports the advantage of sustaining maternal blood pressure above 90% of the baseline value.
The objective of this study is to investigate the impact of varying maternal blood pressure maintenance targets on maternal hemodynamics following cesarean section.
Study Type
Interventional
Enrollment (Estimated)
300
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 Contact
- Name: Yi Chen, M.D.
- Phone Number: +86-0951-6743252
- Email: czzyxgp@163.com
Study Contact Backup
- Name: Xinli Ni, Ph.D
- Phone Number: +86-0951-6743252
- Email: xinlini6@nyfy.com.cn
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
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 18-45 years
- Primipara or multipara
- Singleton pregnancy ≥37 weeks
- American Society of Anesthesiologists physical status classification I to II
- Scheduled for cesarean section under spinal anesthesia
Exclusion Criteria:
- Body height < 150 cm
- Body weight > 100 kg or body mass index (BMI) ≥ 40 kg/m2
- Eclampsia or chronic hypertension or baseline blood pressure ≥180 mmHg
- 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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Standard group
The maternal systolic blood pressure was consistently maintained above 80% of the preoperative baseline value from the initiation of spinal anesthesia until fetal delivery.
|
The maternal systolic blood pressure was consistently maintained above 80% of the preoperative baseline value from the initiation of spinal anesthesia until fetal delivery.
Other Names:
|
Experimental: Intensive group
The maternal systolic blood pressure was consistently maintained above 90% of the preoperative baseline value from the initiation of spinal anesthesia until fetal delivery.
|
The maternal systolic blood pressure was consistently maintained above 90% of the preoperative baseline value from the initiation of spinal anesthesia until fetal delivery.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiac output
Time Frame: 1-15 minutes after spinal anesthesia.
|
Monitoring data
|
1-15 minutes after spinal anesthesia.
|
Cardiac index
Time Frame: 1-15 minutes after spinal anesthesia.
|
Monitoring data
|
1-15 minutes after spinal anesthesia.
|
Stroke volume variation
Time Frame: 1-15 minutes after spinal anesthesia.
|
Monitoring data
|
1-15 minutes after spinal anesthesia.
|
Peripheral vascular resistance
Time Frame: 1-15 minutes after spinal anesthesia.
|
Monitoring data
|
1-15 minutes after spinal anesthesia.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pH
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
|
Partial pressure of oxygen (PO2)
Time Frame: Immediately after delivery
|
From umbilical arterial blood gases.
|
Immediately after delivery
|
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.
|
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.
|
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 hypertension.
Time Frame: 1-15 minutes after spinal anesthesia.
|
Systolic blood pressure (SBP) >120% of the baseline.
|
1-15 minutes after spinal anesthesia.
|
The incidence of bradycardia.
Time Frame: 1-15 minutes after spinal anesthesia.
|
Heart rate < 60 beats/min.
|
1-15 minutes after spinal anesthesia.
|
APGAR score
Time Frame: 1 min after delivery
|
A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration; 0(Worst)-10(Best)
|
1 min after delivery
|
APGAR score
Time Frame: 5 min after delivery
|
A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration; 0(Worst)-10(Best)
|
5 min after delivery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Xinli Ni, Ph.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 (Estimated)
December 1, 2024
Primary Completion (Estimated)
December 31, 2025
Study Completion (Estimated)
December 31, 2025
Study Registration Dates
First Submitted
November 21, 2023
First Submitted That Met QC Criteria
November 28, 2023
First Posted (Actual)
November 30, 2023
Study Record Updates
Last Update Posted (Actual)
November 30, 2023
Last Update Submitted That Met QC Criteria
November 28, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Yi Chen-2024-2
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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