An interventional study of Norepinephrine and Normal saline in Adverse Effect, sponsored by General Hospital of Ningxia Medical University. Completed at 1 site in China. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2020-08-04.
Sponsored by General Hospital of Ningxia Medical University · Not applicable, Interventional, and Prevention
The purpose of this study is to investigate the suitable infusion dose of norepinephrine for prophylaxis against post-spinal anesthesia hypotension.
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.
1,003 studies on the registry are indexed under Hypotension; 173 are open to participants now.
This study's enrollment of 99 is above the median of 80 across 675 interventional studies indexed under Hypotension.
Browse Hypotension studies →General Hospital of Ningxia Medical University is the lead sponsor of 102 studies on the registry; 39 are open to participants now.
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Simultaneous with subarachnoid block, a bolus of 1ml normal saline was given followed by normal saline infusion
Drug: Normal saline
Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by a maintenance dose of norepinephrine (0.025 μg/kg/min).
Drug: Norepinephrine
Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by a maintenance dose of norepinephrine (0.05 μg/kg/min).
Drug: Norepinephrine
Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by a maintenance dose of norepinephrine (0.075 μg/kg/min).
Drug: Norepinephrine
Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by a maintenance dose of norepinephrine (0.1 μg/kg/min).
Drug: Norepinephrine
Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by different infusion dose of norepinephrine.
Also known as: Vasopressors
Simultaneous with subarachnoid block, a bolus of 1ml normal saline was given followed by normal saline infusion
Also known as: NS
The incidence of post-spinal anesthesia hypotension
Systolic blood pressure (SBP) \< 80% of the baseline
Time frame: 1-15 minutes after spinal anesthesia.
Overall stability of systolic blood pressure control versus baseline
Evaluated by performance error (PE).
Time frame: 1-15 minutes after spinal anesthesia.
Overall stability of heart rate control versus baseline
Evaluated by performance error (PE).
Time frame: 1-15 minutes after spinal anesthesia.
The incidence of severe post-spinal anesthesia hypotension.
Systolic blood pressure (SBP) \< 60% of the baseline.
Time frame: 1-15 minutes after spinal anesthesia.
The incidence of nausea and vomiting.
Presence of nausea and vomiting in patients after spinal anesthesia
Time frame: 1-15 minutes after spinal anesthesia.
The incidence of bradycardia.
Heart rate \< 55 beats/min.
Time frame: 1-15 minutes after spinal anesthesia.
The incidence of hypertension.
Systolic blood pressure (SBP) \>120% of the baseline.
Time frame: 1-15 minutes after spinal anesthesia.
pH
From umbilical arterial blood gases.
Time frame: Immediately after delivery.
Partial pressure of oxygen
From umbilical arterial blood gases.
Time frame: Immediately after delivery.
Base excess
From umbilical arterial blood gases.
Time frame: Immediately after delivery.
APGAR score
A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration
Time frame: 1min after delivery
APGAR score
A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration
Time frame: 5min after delivery
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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General Hospital of Ningxia Medical University