The purpose of this study is to investigate the suitable infusion dose of prophylactic norepinephrine infusion combined with 6% Hydroxyethyl starch (130/0.4) coload for post-spinal anesthesia hypotension in patients undergoing cesarean section.
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. But the ideal infusion dose of norepinephrine with colloid coload is still unknown. The purpose of this study is to investigate the suitable infusion dose of prophylactic norepinephrine infusion combined with 6% Hydroxyethyl starch (130/0.4) coload for post-spinal anesthesia hypotension in patients undergoing cesarean section.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
175
Simultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given and a maintenance dose of normal saline by IV infusion.
Simultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given and a different maintenance dose of norepinephrine by IV infusion.
Simultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given and a different maintenance dose of norepinephrine by IV infusion.
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
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
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 value
Analyse from umbilical arterial blood gases.
Time frame: Immediately after fetal delivery
Partial pressure of oxygen
Analyse from umbilical arterial blood gases.
Time frame: Immediately after fetal delivery
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Simultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given and a different maintenance dose of norepinephrine by IV infusion.
Simultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given and a different maintenance dose of norepinephrine by IV infusion.
Concentration of base excess
Analyse from umbilical arterial blood gases.
Time frame: Immediately after fetal delivery
Apgar score (0-10; a higher score means a better outcome)
A= Appearance (0-2); P=Pulse (0-2); G=Grimace (0-2); A=Attitude (0-2); R=Respiration (0-2)
Time frame: 5 min after fetal delivery
Apgar score (0-10;a higher score means a better outcome)
A= Appearance (0-2); P=Pulse (0-2); G=Grimace (0-2); A=Attitude (0-2); R=Respiration (0-2)
Time frame: 5 min after fetal delivery