Norepinephrine Prophylaxis for Postspinal Anesthesia Hypotension in Parturients With Preeclampsia

Sponsor

General Hospital of Ningxia Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT04556357

Collaborator

(none)

138

Enrollment

Location

Arms

13.8

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Adverse Effect	Drug: Phenylephrine 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 efficacy and safety in parturients with preeclampsia is still unknown. The purpose of this study is to investigate the efficacy and safety of norepinephrine for prophylaxis against post-spinal anesthesia hypotension in parturients with preeclampsia undergoing cesarean section.

Study Design

Study Type:

Interventional

Actual Enrollment :

138 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, Controlled Trial

Actual Study Start Date :

Sep 22, 2020

Actual Primary Completion Date :

Nov 15, 2021

Actual Study Completion Date :

Nov 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Control group Phenylephrine infusion simultaneous with subarachnoid block	Drug: Phenylephrine A maintenance dose of phenylephrine (0.625 μg/kg/min) infusion simultaneous with subarachnoid block Other Names: Vasopressors
Experimental: Norepinephrine group Norepinephrine infusion simultaneous with subarachnoid block	Drug: Norepinephrine A maintenance dose of norepinephrine (0.05 μg/kg/min) infusion simultaneous with subarachnoid block Other Names: Vasopressors

Arm

Intervention/Treatment

Active Comparator: Control group

Phenylephrine infusion simultaneous with subarachnoid block

Drug: Phenylephrine

A maintenance dose of phenylephrine (0.625 μg/kg/min) infusion simultaneous with subarachnoid block

Other Names:

Vasopressors

Experimental: Norepinephrine group

Norepinephrine infusion simultaneous with subarachnoid block

Drug: Norepinephrine

A maintenance dose of norepinephrine (0.05 μg/kg/min) infusion simultaneous with subarachnoid block

Other Names:

Vasopressors

Outcome Measures

Primary Outcome Measures

The incidence of bradycardia [1-15 minutes after spinal anesthesia.]
Heart rate < 60 beats/min

Secondary Outcome Measures

Overall stability of systolic blood pressure control versus baseline [1-15 minutes after spinal anesthesia]
Evaluated by performance error (PE)

Other Outcome Measures

Overall stability of heart rate control versus baseline [1-15 minutes after spinal anesthesia]
Evaluated by performance error (PE)
The incidence of postspinal anesthesia hypotension [1-15 minutes after spinal anesthesia]
Systolic blood pressure (SBP) < 80% of the baseline
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 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