General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004, China
NCT Number: NCT05712018
The purpose of this study is to investigate the effect of different 6% hydroxyethyl starch (130/0.4) coload volumes on the 90% effective dose of norepinephrine infusion prophylaxis for hypotension during spinal anesthesia for cesarean section.
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Notify Me18 year–45 year
Female
Interventional
Not applicable
Yinchuan, Ningxia, 750004, China
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. 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. The purpose of this study is to investigate the effect of different 6% hydroxyethyl starch (130/0.4) coload volumes on the 90% effective dose of norepinephrine infusion prophylaxis for hypotension during spinal anesthesia for cesarean section.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
No fluid coload was given. 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.
Other names: Colloid
5 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.
Other names: Colloid
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.
Other names: Colloid
Time frame: 1-15 minutes after spinal anesthesia
The dose of prophylactic norepinephrine that would be effective in preventing postspinal anesthesia hypotension in 50% (effective dose, ED 50) of patients
Time frame: 1-15 minutes after spinal anesthesia
The dose of prophylactic norepinephrine that would be effective in preventing postspinal anesthesia hypotension in 90% (ED90) of patients
Time frame: 1-15 minutes after spinal anesthesia
Systolic blood pressure (SBP) < 80% of the baseline
Time frame: 1-15 minutes after spinal anesthesia
Systolic blood pressure (SBP) < 60% of the baseline
Time frame: 1-15 minutes after spinal anesthesia
Heart rate < 60 beats/min
Time frame: 1-15 minutes after spinal anesthesia
Presence of nausea and vomiting in patients after spinal anesthesia
Time frame: 1-15 minutes after spinal anesthesia
Systolic blood pressure (SBP) >120% of the baseline
Time frame: Immediately after delivery
From umbilical arterial blood gases
Time frame: Immediately after delivery
From umbilical arterial blood gases
Time frame: Immediately after delivery
From umbilical arterial blood gases
Time frame: 1 min after delivery
A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration
Time frame: 5 min after delivery
A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration
General Hospital of Ningxia Medical University
Other
Comparison of Different 6% Hydroxyethyl Starch (130/0.4) Coload Volumes on the 90% Effective Dose of Norepinephrine Infusion Prophylaxis for Hypotension During Spinal Anesthesia for Cesarean Section
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