Different Crystalloid Coload Volumes on the 90% ED of Norepinephrine
- Conditions
- Adverse Effect
- Interventions
- Drug: Crystalloid - 0 ml/kgDrug: Crystalloid - 5 ml/kgDrug: Crystalloid - 10 ml/kg
- Registration Number
- NCT05690334
- Lead Sponsor
- General Hospital of Ningxia Medical University
- Brief Summary
The purpose of this study is to investigate the effect of different crystalloid coload volumes on the 90% effective dose of prophylactic norepinephrine infusions for preventing postspinal anesthesia hypotension during 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. Coload has been highly demonstrated for prevention and/or treatment of post-spinal anesthesia hypotension. In addition, there's some evidence that prophylactic infusion of norepinephrine could effectively reduce the incidence of post-spinal anesthesia hypotension in parturients undergoing cesarean section. The purpose of this study is to investigate the effect of different crystalloid coload volumes on the 90% effective dose of norepinephrine infusion prophylaxis for hypotension during spinal anesthesia for cesarean section.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 90
- 18-45 years
- Primipara or multipara
- Singleton pregnancy ≥37 weeks
- American Society of Anesthesiologists physical status classification I to II
- Scheduled for cesarean section under spinal anesthesia
- Body height < 150 cm
- Body weight > 100 kg or body mass index (BMI) ≥ 40 kg/m2
- Eclampsia or chronic hypertension or baseline blood pressure ≥180 mmHg
- Hemoglobin < 7g/dl
- Fetal distress, or known fetal developmental anomaly
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group Crystalloid - 0 ml/kg No fluid coload was given. An initial infusion dose of prophylactic norepinephrine simultaneous with spinal anesthesia Crystalloid - 5 ml/kg Crystalloid - 5 ml/kg 5 ml/kg crystalloid coload combined with an initial infusion dose of prophylactic norepinephrine simultaneous with spinal anesthesia. Crystalloid - 10 ml/kg Crystalloid - 10 ml/kg 10 ml/kg crystalloid coload combined with an initial infusion dose of prophylactic norepinephrine simultaneous with spinal anesthesia.
- Primary Outcome Measures
Name Time Method ED50 and ED90 1-15 minutes after spinal anesthesia The dose of prophylactic norepinephrine that would be effective in preventing postspinal anesthesia hypotension in 50% (effective dose, ED 50) and 90% (ED90) of patients
- Secondary Outcome Measures
Name Time Method pH Immediately after delivery From umbilical arterial blood gases
Partial pressure of oxygen (PO2) Immediately after delivery From umbilical arterial blood gases
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
Base excess (BE) Immediately after delivery From umbilical arterial blood gases
APGAR score 5 minute after delivery A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration
Trial Locations
- Locations (1)
General Hospital of Ningxia Medical University
🇨🇳Yinchuan, Ningxia, China