Clinical trial NCT06151444: Intensive Versus Standard Treatment for Hypotension on Maternal Hemodynamics in Preeclamptic Patients
Official title: Intensive Versus Standard Treatment for Spinal Anesthesia-induced Hypotension on Maternal Hemodynamics in Preeclamptic Patients During Cesarean Section
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Adverse Effect
Lead sponsor: General Hospital of Ningxia Medical University
Sponsor class: OTHER
First posted: 2023-11-30
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to investigate the impact of varying maternal blood pressure maintenance targets on maternal hemodynamics in preeclamptic patients following cesarean section.

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 in preeclamptic patients following cesarean section.

Eligibility criteria: Inclusion Criteria:

* 18-45 years
* Primipara or multipara
* Singleton pregnancy ≥32 weeks
* American Society of Anesthesiologists physical status classification I to III
* Scheduled for cesarean section under spinal anesthesia

Exclusion Criteria:

* Baseline blood pressure ≥160 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

Primary outcomes:
measure: Cardiac output
timeFrame: 1-15 minutes after spinal anesthesia.
measure: Cardiac index
timeFrame: 1-15 minutes after spinal anesthesia.
measure: Stroke volume variation
timeFrame: 1-15 minutes after spinal anesthesia.
measure: Peripheral vascular resistance
timeFrame: 1-15 minutes after spinal anesthesia.
Secondary outcomes:
measure: The incidence of post-spinal anesthesia hypotension
timeFrame: 1-15 minutes after spinal anesthesia.
measure: The incidence of severe post-spinal anesthesia hypotension.
timeFrame: 1-15 minutes after spinal anesthesia.
measure: The incidence of bradycardia.
timeFrame: 1-15 minutes after spinal anesthesia.
measure: The incidence of nausea and vomiting.
timeFrame: 1-15 minutes after spinal anesthesia.
measure: The incidence of hypertension.
timeFrame: 1-15 minutes after spinal anesthesia.
measure: pH
timeFrame: Immediately after delivery
measure: Base excess
timeFrame: Immediately after delivery
measure: Partial pressure of oxygen (PO2)
timeFrame: Immediately after delivery
measure: APGAR score
timeFrame: 1 min after delivery
measure: APGAR score
timeFrame: 5 min after delivery
Other outcomes:
Locations:
Study officials:
affiliation: General Hospital of Ningxia Medical University
name: Yi Chen, M.D.
role: STUDY_CHAIR
References: