General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 75004, China
NCT Number: NCT05133817
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.
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Notify Me18 year–40 year
Female
Interventional
Not applicable
Yinchuan, Ningxia, 75004, 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. 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Criteria: Inclusion Criteria:
Exclusion criteria
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.
Other names: NS
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.
Other names: Vasopressor
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.
Other names: Vasopressor
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.
Other names: Vasopressor
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.
Other names: Vasopressor
Time frame: 1-15 minutes after spinal anesthesia
Systolic blood pressure (SBP) < 80% of the baseline
Time frame: 1-15 minutes after spinal anesthesia
Evaluated by performance error (PE).
Time frame: 1-15 minutes after spinal anesthesia
Systolic blood pressure (SBP) < 60% of the baseline.
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
Heart rate < 55 beats/min.
Time frame: 1-15 minutes after spinal anesthesia
Systolic blood pressure (SBP) >120% of the baseline.
Time frame: Immediately after fetal delivery
Analyse from umbilical arterial blood gases.
Time frame: Immediately after fetal delivery
Analyse from umbilical arterial blood gases.
Time frame: Immediately after fetal delivery
Analyse from umbilical arterial blood gases.
Time frame: 5 min after fetal delivery
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
A= Appearance (0-2); P=Pulse (0-2); G=Grimace (0-2); A=Attitude (0-2); R=Respiration (0-2)
General Hospital of Ningxia Medical University
Other
Prophylactic Norepinephrine Infusion Combined With 6% Hydroxyethyl Starch (130/0.4) Coload for Postspinal Anesthesia Hypotension in Patients Undergoing Cesarean Section: A Randomized, Controlled, Dose-finding Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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