Norepinephrine Prophylaxis for Postspinal Anesthesia Hypotension
- Registration Number
- NCT04272567
- Lead Sponsor
- General Hospital of Ningxia Medical University
- Brief Summary
The purpose of this study is to investigate the suitable infusion dose of norepinephrine for prophylaxis against post-spinal anesthesia hypotension.
- 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. Vasopressors has been highly recommended for routine prevention and/or treatment of post-spinal anesthesia hypotension. As a potential substitute drug for phenylephrine, norepinephrine has gradually been used in parturients undergoing cesarean section. There's some evidence that prophylactic infusion of norepinephrine could effectively reduce the incidence of post-spinal anesthesia hypotension in parturients undergoing cesarean section. But the ideal infusion dose of norepinephrine is still unknown. The purpose of this study is to investigate the suitable infusion dose of norepinephrine for prophylaxis against post-spinal anesthesia hypotension.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 99
- 18-40 years
- Primipara or multipara
- Singleton pregnancy ≥37 weeks
- American Society of Anesthesiologists physical status classification I to II
- Scheduled for elective 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 ≥ 160mmHg
- 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 Normal saline Simultaneous with subarachnoid block, a bolus of 1ml normal saline was given followed by normal saline infusion 0.025 μg/kg/min group Norepinephrine Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by a maintenance dose of norepinephrine (0.025 μg/kg/min). 0.05 μg/kg/min group Norepinephrine Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by a maintenance dose of norepinephrine (0.05 μg/kg/min). 0.075 μg/kg/min group Norepinephrine Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by a maintenance dose of norepinephrine (0.075 μg/kg/min). 0.1 μg/kg/min group Norepinephrine Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by a maintenance dose of norepinephrine (0.1 μg/kg/min).
- Primary Outcome Measures
Name Time Method The incidence of post-spinal anesthesia hypotension 1-15 minutes after spinal anesthesia. Systolic blood pressure (SBP) \< 80% of the baseline
- Secondary Outcome Measures
Name Time Method 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 bradycardia. 1-15 minutes after spinal anesthesia. Heart rate \< 55 beats/min.
The incidence of hypertension. 1-15 minutes after spinal anesthesia. Systolic blood pressure (SBP) \>120% of the baseline.
Overall stability of systolic blood pressure control versus baseline 1-15 minutes after spinal anesthesia. Evaluated by performance error (PE).
Overall stability of heart rate control versus baseline 1-15 minutes after spinal anesthesia. Evaluated by performance error (PE).
The incidence of severe post-spinal anesthesia hypotension. 1-15 minutes after spinal anesthesia. Systolic blood pressure (SBP) \< 60% of the baseline.
pH Immediately after delivery. From umbilical arterial blood gases.
Partial pressure of oxygen Immediately after delivery. From umbilical arterial blood gases.
Base excess Immediately after delivery. From umbilical arterial blood gases.
APGAR score 5min 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