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
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
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
General Hospital of Ningxia Medical University🇨🇳Yinchuan, Ningxia, China