Outcome
Conditions
Keywords
Spinal anesthesia-induced hypotension, Norepinephrine, Phenylephrine, Neonatal outcomes, Cesarean section
Brief summary
This study aims to explore the effects of different application modes (prophylactic and rescue strategy) of norepinephrine and norepinephrine on neonate umbilical artery pH undergoing cesarean section.
Detailed description
Spinal anesthesia-induced hypotension is a frequent complication during spinal anesthesia for cesarean section. The incidence of spinal anesthesia-induced 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 spinal anesthesia-induced hypotension. The prophylactic vasopressor strategy is more effective in enhancing hemodynamic stability and reducing adverse events such as nausea and vomiting during cesarean section, compared to rescue strategy. However, it does not demonstrate significant advantages in neonatal outcomes such as umbilical artery pH and Apgar score. The impact of various vasopressor application patterns on neonatal outcomes after cesarean section lacks further supporting evidence. Therefore, this study aims to explore the effects of different application modes (prophylactic and rescue strategy) of norepinephrine and norepinephrine on neonate umbilical artery pH undergoing cesarean section through a multicenter, single-blind, 2\*2 crossover and cluster randomized trial.
Interventions
DRUGNorepinephrine
Prophylactic or rescue norepinephrine for spinal anesthesia-induced hypotension
DRUGPhenylephrine
Prophylactic or rescue phenylephrine for spinal anesthesia-induced hypotension
Sponsors
General Hospital of Ningxia Medical University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* 18-45 years * Primipara or multipara * Singleton pregnancy ≥37 weeks * American Society of Anesthesiologists physical status classification 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 ≥140 mmHg * Hemoglobin \< 7g/dl * Fetal distress, or known fetal developmental anomaly
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pH | Immediately after delivery | From umbilical arterial blood gases. |
| Base excess (BE) | Immediately after delivery | From umbilical arterial blood gases. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of post-spinal anesthesia hypotension | 1-15 minutes after spinal anesthesia | Systolic blood pressure (SBP) \< 80% of the baseline |
| The incidence of severe post-spinal anesthesia hypotension | 1-15 minutes after spinal anesthesia | Systolic blood pressure (SBP) \< 60% of the baseline |
| The incidence of bradycardia | 1-15 minutes after spinal anesthesia | Heart rate \< 60 beats/min |
| The incidence of nausea and vomiting | 1-15 minutes after spinal anesthesia | Presence of nausea and vomiting in patients after spinal anesthesia |
| The incidence of hypertension | 1-15 minutes after spinal anesthesia | Systolic blood pressure (SBP) \>120% of the baseline. |
| Partial pressure of oxygen (PO2) | Immediately after delivery | From umbilical arterial blood gases. |
| APGAR score | 1 min after delivery | A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration |
Countries
China
Contacts
STUDY_CHAIRYi Chen, M.D.
General Hospital of Ningxia Medical University
Outcome results
None listed