Norepinephrine Prophylaxis for Postspinal Anesthesia Hypotension in Parturients With Preeclampsia.

Sponsor

General Hospital of Ningxia Medical University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04556370

Collaborator

(none)

Enrollment

Location

Arms

20.3

Anticipated Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate the suitable infusion dose of norepinephrine for prophylaxis against postspinal anesthesia hypotension in parturients with preeclampsia undergoing cesarean section.

Condition or Disease	Intervention/Treatment	Phase
Adverse Effect	Drug: Normal saline Drug: Norepinephrine	N/A

Detailed Description

Preeclampsia, which affects 5% to 7% of parturients, is a significant cause of maternal and neonatal morbidity and mortality. Because of constricted myometrial spiral arteries with exaggerated vasomotor responsiveness, though blood pressure in parturients with preeclampsia are apparently higher than healthy parturients, placental hypoperfusion is more common. Spinal anesthesia is still the preferred mode of anesthesia in parturients with preeclampsia for cesarean section. In preeclampsia parturients, spinal anesthesia improve intervillous blood flow (provided that hypotension is avoided) which contribute to increase placental perfusion. Even so, 17-26% parturients with preeclampsia experienced postspinal anesthesia hypotension due to the extensive sympathetic block that occurred with spinal anesthesia. As a potential substitute drug for phenylephrine and ephedrine, norepinephrine has gained traction for use in parturients undergoing cesarean section. But the suitable infusion dose of norepinephrine in parturients with preeclampsia is still unknown. The purpose of this study is to investigate the suitable infusion dose of norepinephrine for prophylaxis against post-spinal anesthesia hypotension in parturients with preeclampsia undergoing cesarean section.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

92 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Norepinephrine Prophylaxis for Postspinal Anesthesia Hypotension in Parturients With Preeclampsia Undergoing Cesarean Section: a Randomized, Placebo-controlled Dose-finding Trial

Actual Study Start Date :

Nov 16, 2021

Anticipated Primary Completion Date :

Jul 26, 2023

Anticipated Study Completion Date :

Jul 26, 2023

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Control group Normal saline infusion simultaneous with subarachnoid block	Drug: Normal saline Normal saline infusion simultaneous with subarachnoid block Other Names: NS
Experimental: 0.025 μg/kg/min group A maintenance dose of norepinephrine (0.025 μg/kg/min) infusion simultaneous with subarachnoid block	Drug: Norepinephrine Different infusion dose of norepinephrine simultaneous with subarachnoid block Other Names: Vasopressors
Experimental: 0.050 μg/kg/min group A maintenance dose of norepinephrine (0.050 μg/kg/min) infusion simultaneous with subarachnoid block	Drug: Norepinephrine Different infusion dose of norepinephrine simultaneous with subarachnoid block Other Names: Vasopressors
Experimental: 0.075 μg/kg/min group A maintenance dose of norepinephrine (0.075 μg/kg/min) infusion simultaneous with subarachnoid block	Drug: Norepinephrine Different infusion dose of norepinephrine simultaneous with subarachnoid block Other Names: Vasopressors

Outcome Measures

Primary Outcome Measures

The incidence of post-spinal anesthesia hypotension [1-15 minutes after spinal anesthesia.]
Systolic blood pressure (SBP) < 80% of the baseline

Secondary Outcome Measures

Overall stability of systolic blood pressure control versus baseline [1-15 minutes after spinal anesthesia]
Evaluated by performance error (PE)
Overall stability of heart rate control versus baseline [1-15 minutes after spinal anesthesia]
Evaluated by performance error (PE)
The incidence of severe post-spinal anesthesia hypotension [1-15 minutes after spinal anesthesia]
Systolic blood pressure (SBP) < 60% of the baseline
The incidence of nausea and vomiting [1-15 minutes after spinal anesthesia]
Presence of nausea and vomiting in patients after spinal anesthesia
The incidence of bradycardia [1-15 minutes after spinal anesthesia]
Heart rate < 55 beats/min
The incidence of hypertension. [1-15 minutes after spinal anesthesia]
Systolic blood pressure (SBP) >120% of the baseline.
pH [Immediately after delivery]
From umbilical arterial blood gases.
Partial pressure of oxygen [Immediately after delivery]
From umbilical arterial blood gases.
Base excess [Immediately after delivery]
From umbilical arterial blood gases.
APGAR score [1 min after delivery]
A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration
APGAR score [5 min after delivery]
A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration