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NCT06151431 | RECRUITING | Adverse Effect

Intensive Versus Standard Treatment for Spinal Anesthesia-induced Hypotension in Preeclamptic Patients
Sponsor:

General Hospital of Ningxia Medical University

Brief Summary:

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

Condition or disease

Adverse Effect

Intervention/treatment

Alpha-Agonist

α-adrenergic receptor agonist

Phase

NA

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 neonatal outcomes in preeclamptic patients following cesarean section.

Study Type : INTERVENTIONAL
Estimated Enrollment : 300 participants
Masking : SINGLE
Primary Purpose : TREATMENT
Official Title : Intensive Versus Standard Treatment for Spinal Anesthesia-induced Hypotension on Neonatal Outcomes in Preeclamptic Patients During Cesarean Section
Actual Study Start Date : 2023-12-05
Estimated Primary Completion Date : 2024-06-30
Estimated Study Completion Date : 2024-06-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 45 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
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
Intensive Versus Standard Treatment for Spinal Anesthesia-induced Hypotension in Preeclamptic Patients

Location Details

NCT06151431

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Locations

RECRUITING

China, Ningxia

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China, 750004