Norepinephrine Prophylaxis for Postspinal Anesthesia Hypotension in Parturients Undergoing Cesarean Section: a Randomized, Placebo-controlled Dose-finding Trial
Overview
- Phase
- Not Applicable
- Intervention
- Normal saline
- Conditions
- Adverse Effect
- Sponsor
- General Hospital of Ningxia Medical University
- Enrollment
- 99
- Locations
- 1
- Primary Endpoint
- The incidence of post-spinal anesthesia hypotension
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
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 ≥ 160mmHg
- •Hemoglobin \< 7g/dl
- •Fetal distress, or known fetal developmental anomaly
Arms & Interventions
Control group
Simultaneous with subarachnoid block, a bolus of 1ml normal saline was given followed by normal saline infusion
Intervention: Normal saline
0.025 μg/kg/min group
Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by a maintenance dose of norepinephrine (0.025 μg/kg/min).
Intervention: Norepinephrine
0.05 μg/kg/min group
Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by a maintenance dose of norepinephrine (0.05 μg/kg/min).
Intervention: Norepinephrine
0.075 μg/kg/min group
Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by a maintenance dose of norepinephrine (0.075 μg/kg/min).
Intervention: Norepinephrine
0.1 μg/kg/min group
Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by a maintenance dose of norepinephrine (0.1 μg/kg/min).
Intervention: Norepinephrine
Outcomes
Primary Outcomes
The incidence of post-spinal anesthesia hypotension
Time Frame: 1-15 minutes after spinal anesthesia.
Systolic blood pressure (SBP) \< 80% of the baseline
Secondary Outcomes
- The incidence of nausea and vomiting.(1-15 minutes after spinal anesthesia.)
- The incidence of bradycardia.(1-15 minutes after spinal anesthesia.)
- The incidence of hypertension.(1-15 minutes after spinal anesthesia.)
- Overall stability of systolic blood pressure control versus baseline(1-15 minutes after spinal anesthesia.)
- Overall stability of heart rate control versus baseline(1-15 minutes after spinal anesthesia.)
- The incidence of severe post-spinal anesthesia hypotension.(1-15 minutes after spinal anesthesia.)
- pH(Immediately after delivery.)
- Partial pressure of oxygen(Immediately after delivery.)
- Base excess(Immediately after delivery.)
- APGAR score(5min after delivery)