An interventional study of Alpha-Agonist and α-adrenergic receptor agonist in Outcome, sponsored by General Hospital of Ningxia Medical University. Completed at 1 site in China. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2024-08-21.
Sponsored by General Hospital of Ningxia Medical University · Not applicable, Interventional, and Treatment
The objective of this study is to investigate the impact of varying maternal blood pressure maintenance targets on neonatal outcomes following cesarean section.
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 neonatal outcomes following cesarean section.
General Hospital of Ningxia Medical University is the lead sponsor of 106 studies on the registry; 40 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Criteria: Inclusion Criteria:
Exclusion Criteria:
The maternal systolic blood pressure was consistently maintained above 80% of the preoperative baseline value from the initiation of spinal anesthesia until fetal delivery.
Drug: Alpha-Agonist
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: α-adrenergic receptor agonist
The maternal systolic blood pressure was consistently maintained above 80% of the preoperative baseline value from the initiation of spinal anesthesia until fetal delivery.
Also known as: Vasopressors
The maternal systolic blood pressure was consistently maintained above 90% of the preoperative baseline value from the initiation of spinal anesthesia until fetal delivery.
Also known as: Vasopressors
pH
From umbilical arterial blood gases.
Time frame: Immediately after delivery
Base excess
From umbilical arterial blood gases.
Time frame: Immediately after delivery
The incidence of post-spinal anesthesia hypotension
Systolic blood pressure (SBP) \< 80% of the baseline
Time frame: 1-15 minutes after spinal anesthesia
The incidence of severe post-spinal anesthesia hypotension.
Systolic blood pressure (SBP) \< 60% of the baseline.
Time frame: 1-15 minutes after spinal anesthesia
The incidence of bradycardia.
Heart rate \< 50 beats/min.
Time frame: 1-15 minutes after spinal anesthesia
The incidence of nausea and vomiting.
Presence of nausea and vomiting in patients after spinal anesthesia
Time frame: 1-15 minutes after spinal anesthesia
The incidence of hypertension.
Systolic blood pressure (SBP) \>120% of the baseline.
Time frame: 1-15 minutes after spinal anesthesia
Partial pressure of oxygen (PO2)
From umbilical arterial blood gases.
Time frame: Immediately after delivery
APGAR score
A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration; 0(Worst)-10(Best)
Time frame: 1 min after delivery
APGAR score
A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration; 0(Worst)-10(Best)
Time frame: 5 min after delivery
Ran from Dec 2023 to primary completion in Aug 2024, 8 months.
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This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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General Hospital of Ningxia Medical University →