General hospital of Ningxia University
Yinchuan, Ningxia, 750004, China
NCT Number: NCT06158022
The objective of this study is to investigate the ED90 of norepinephrine and phenylephrine infusions for preventing postspinal anesthesia hypotension under intensive treatment in preeclamptic patients during 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. The 2016 ASA guidelines for obstetric anesthesia suggest avoiding hypotension following spinal anesthesia in women and emphasize the use of vasopressors, specifically alpha-receptor agonists, as the preferred strategy to prevent and manage post-spinal anesthesia hypotension. The 2018 International Consensus in the United Kingdom and Northern Ireland recommends maintaining maternal systolic blood pressure above 90% of the baseline value following lumbar anesthesia, while avoiding dropping below 80% of the baseline value. Currently, the threshold for maintaining blood pressure above 80% of the baseline value is widely adopted as a standard; however, limited evidence supports the advantage of sustaining maternal blood pressure above 90% of the baseline value. The objective of this study is to investigate the ED90 of norepinephrine and phenylephrine infusions for preventing postspinal anesthesia hypotension under intensive treatment in preeclamptic patients during cesarean section
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
An initial infusion dose of prophylactic norepinephrine (0.05 ug/kg/min) simultaneous with spinal anesthesia. The dose administered to subsequent patients varied by increments or decrements of 0.01 ug/kg/min of prophylactic norepinephrine according to the responses of previous patients according to the up-down sequential allocation.
Other names: Vasopressor
An initial infusion dose of prophylactic phenylephrine (0.5 ug/kg/min) simultaneous with spinal anesthesia. The dose administered to subsequent patients varied by increments or decrements of 0.1 ug/kg/min of prophylactic phenylephrine according to the responses of previous patients according to the up-down sequential allocation.
Other names: Vasopressor
Time frame: 1-15 minutes after spinal anesthesia
The doses of prophylactic norepinephrine and phenylephrine 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.
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 fetal delivery
A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration; 0(Worst)-10(Best)
Time frame: 5 min after fetal delivery
A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration; 0(Worst)-10(Best)
General Hospital of Ningxia Medical University
Other
Determination of ED90s of Phenylephrine and Norepinephrine Infusion for Strict Blood Pressure Management Targets in Preeclamptic Patients Undergoing Cesarean Section: A Randomized Sequential Allocation Study
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