The purpose of this study is to investigate the ED50 and ED90 for an effective 6% Hydroxyethyl starch (130/0.4) or crystalloid coload combined with prophylactic norepinephrine infusion dose for postspinal 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. Colloid fluid coload has been highly demonstrated for prevention and/or treatment of post-spinal anesthesia hypotension. In addition, 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, the ED50 and ED90 for an effective 6% Hydroxyethyl starch (130/0.4) or crystalloid coload combined with prophylactic norepinephrine infusion dose for postspinal anesthesia hypotension is still unknown. The purpose of this study is to investigate the ED50 and ED90 for an effective 6% Hydroxyethyl starch (130/0.4) or crystalloid coload combined with prophylactic norepinephrine infusion dose for postspinal anesthesia hypotension in patients undergoing cesarean section.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
10 ml/kg 6% Hydroxyethyl starch (130/0.4) coload combined with an initial infusion dose of prophylactic norepinephrine (0.025 ug/kg/min) simultaneous with spinal anesthesia. The dose administered to subsequent patients varied by increments or decrements of 0.005 ug/kg/min of prophylactic norepinephrine according to the responses of previous patients according to the up-down sequential allocation.
10 ml/kg crystalloid coload combined with an initial infusion dose of prophylactic norepinephrine (0.025 ug/kg/min) simultaneous with spinal anesthesia. The dose administered to subsequent patients varied by increments or decrements of 0.005 ug/kg/min of prophylactic norepinephrine according to the responses of previous patients according to the up-down sequential allocation.
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
ED 50 and ED 90
The dose of prophylactic norepinephrine combined with 10 ml/kg 6% Hydroxyethyl starch (130/0.4) or 10 ml/kg crystalloid coload that would be effective in preventing postspinal anesthesia hypotension in 50% (effective dose, ED 50) and 90% (ED90) of patients
Time frame: 1-15 minutes after spinal anesthesia
The incidence of post-spinal anesthesia hypotension
Systolic blood pressure (SBP) \< 80% of the baseline
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 bradycardia.
Heart rate \< 60 beats/min.
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 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 (PO2)
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From umbilical arterial blood gases.
Time frame: Immediately after delivery
Base excess (BE)
From umbilical arterial blood gases.
Time frame: Immediately after delivery
APGAR score
A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration
Time frame: 1 min after delivery
APGAR score
A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration
Time frame: 5 min after delivery