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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05035485
Other study ID # Yi Chen-2021-2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 13, 2022
Est. completion date January 21, 2024

Study information

Verified date January 2024
Source General Hospital of Ningxia Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to investigate the maternal cardiac output response to rescue norepinephrine and phenylephrine boluses for postspinal anesthesia hypotension in parturients with preeclampsia undergoing cesarean section.


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. However, hemodynamic effects of the rescue norepinephrine bolus is still unknown. The purpose of this study is to investigate the maternal cardiac output response to rescue norepinephrine and phenylephrine boluses for postspinal anesthesia hypotension in parturients with preeclampsia undergoing cesarean section.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date January 21, 2024
Est. primary completion date January 21, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Phenylephrine
A rescue phenylephrine (75µg) was given when postspinal anesthesia hypotension occurred within 30 minutes after spinal anesthesia
Norepinephrine
A rescue norepinephrine (6µg) was given when postspinal anesthesia hypotension occurred within 30 minutes after spinal anesthesia

Locations

Country Name City State
China General Hospital of Ningxia Medical University Yinchuan Ningxia

Sponsors (1)

Lead Sponsor Collaborator
General Hospital of Ningxia Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cardiac output (CO) Evaluated by the VIGILCO monitoring system. 1-30 minutes after spinal anesthesia.
Primary Stroke volume (SV) Evaluated by the VIGILCO monitoring system. 1-30 minutes after spinal anesthesia
Primary Systemic vascular resistance (SVR) Evaluated by the VIGILCO monitoring system. 1-30 minutes after spinal anesthesia
Secondary Overall stability of systolic blood pressure control versus baseline Evaluated by performance error (PE) 1-30 minutes after spinal anesthesia
Secondary Overall stability of heart rate control versus baseline Evaluated by performance error (PE) 1-30 minutes after spinal anesthesia
Secondary The incidence of post-spinal anesthesia hypotension Systolic blood pressure (SBP) < 80% of the baseline 1-30 minutes after spinal anesthesia.
Secondary The incidence of severe post-spinal anesthesia hypotension. Systolic blood pressure (SBP) < 60% of the baseline 1-30 minutes after spinal anesthesia.
Secondary The incidence of nausea and vomiting. Presence of nausea and vomiting in patients after spinal anesthesia 1-30 minutes after spinal anesthesia
Secondary The incidence of bradycardia. Heart rate < 60 beats/min. 1-30 minutes after spinal anesthesia
Secondary The incidence of hypertension. Systolic blood pressure (SBP) >120% of the baseline. 1-30 minutes after spinal anesthesia
Secondary pH From umbilical arterial blood gases. Immediately after delivery
Secondary Partial pressure of oxygen (PO2) From umbilical arterial blood gases. Immediately after delivery
Secondary Base excess (BE) From umbilical arterial blood gases. Immediately after delivery
Secondary APGAR score A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration 1 min after delivery
Secondary APGAR score A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration 5 min after delivery
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