Prophylactic Norepinephrine and Phenylephrine Boluses for Postspinal Anesthesia Hypotension
- Registration Number
- NCT05035888
- Lead Sponsor
- General Hospital of Ningxia Medical University
- Brief Summary
The purpose of this study is to investigate the potency between prophylactic norepinephrine and phenylephrine boluses for postspinal anesthesia hypotension in patients undergoing caesarean 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. Vasopressor 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. However, few studies had been indicated the ED50 (prevent postspinal hypotension in 50% of patients) and ED90 of prophylactic norepinephrine bolus and its potency compared to phenylephrine for postspinal anesthesia hypotension in patients undergoing caesarean section. The purpose of this study is to investigate the potency between prophylactic norepinephrine and phenylephrine boluses for postspinal anesthesia hypotension in patients undergoing caesarean section.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 80
- 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 Norepinephrine group Norepinephrine Prophylactic norepinephrine bolus simultaneous with spinal anesthesia Phenylephrine group Phenylephrine Prophylactic phenylephrine bolus simultaneous with spinal anesthesia
- Primary Outcome Measures
Name Time Method The dose that would be effective in preventing postspinal anesthesia hypotension in 50% (effective dose, ED 50) and 90% (ED90) of patients 1-15 minutes after spinal anesthesia Systolic blood pressure (SBP) \< 80% of the baseline
- Secondary Outcome Measures
Name Time Method The incidence of hypertension. 1-15 minutes after spinal anesthesia Systolic blood pressure (SBP) \>120% of the baseline.
The incidence of post-spinal anesthesia hypotension 1-15 minutes after spinal anesthesia Systolic blood pressure (SBP) \< 80% of the baseline
The incidence of nausea and vomiting. 1-15 minutes after spinal anesthesia Presence of nausea and vomiting in patients after spinal anesthesia
Partial pressure of oxygen (PO2) Immediately after delivery From umbilical arterial blood gases.
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.
pH Immediately after delivery From umbilical arterial blood gases.
Base excess (BE) Immediately after delivery From umbilical arterial blood gases.
APGAR score 5 min 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