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Norepinephrine Prophylaxis for Postspinal Anesthesia Hypotension in Parturients With Preeclampsia.

Primary Purpose

Adverse Effect

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Normal saline

Norepinephrine

About this trial

This is an interventional treatment trial for Adverse Effect focused on measuring Norepinephrine, Postspinal anesthesia hypotension, Preeclampsia, Cesarean section, Dose-finding

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

18-45 years
Primipara or multipara
Singleton pregnancy ≥32 weeks
American Society of Anesthesiologists physical status classification II to III
Scheduled for cesarean section under spinal anesthesia

Exclusion Criteria:

Baseline blood pressure ≥180 mmHg
Body height < 150 cm
Body weight > 100 kg or body mass index (BMI) ≥ 40 kg/m2
Eclampsia or chronic hypertension
Hemoglobin < 7g/dl
Fetal distress, or known fetal developmental anomaly

Sites / Locations

General Hospital of Ningxia Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Arm Label

Control group

0.025 μg/kg/min group

0.050 μg/kg/min group

0.075 μg/kg/min group

Arm Description

Normal saline infusion simultaneous with subarachnoid block

A maintenance dose of norepinephrine (0.025 μg/kg/min) infusion simultaneous with subarachnoid block

A maintenance dose of norepinephrine (0.050 μg/kg/min) infusion simultaneous with subarachnoid block

A maintenance dose of norepinephrine (0.075 μg/kg/min) infusion simultaneous with subarachnoid block

Outcomes

Primary Outcome Measures

The incidence of post-spinal anesthesia hypotension

Systolic blood pressure (SBP) < 80% of the baseline

Secondary Outcome Measures

Overall stability of systolic blood pressure control versus baseline

Evaluated by performance error (PE)

Overall stability of heart rate control versus baseline

Evaluated by performance error (PE)

The incidence of severe post-spinal anesthesia hypotension

Systolic blood pressure (SBP) < 60% of the baseline

The incidence of nausea and vomiting

Presence of nausea and vomiting in patients after spinal anesthesia

The incidence of bradycardia

Heart rate < 55 beats/min

The incidence of hypertension.

Systolic blood pressure (SBP) >120% of the baseline.

From umbilical arterial blood gases.

Partial pressure of oxygen

From umbilical arterial blood gases.

Base excess

From umbilical arterial blood gases.

APGAR score

A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration

APGAR score

A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration

Full Information

NCT ID

NCT04556370

First Posted

September 15, 2020

Last Updated

June 9, 2023

Sponsor

General Hospital of Ningxia Medical University

1. Study Identification

Unique Protocol Identification Number

NCT04556370

Brief Title

Norepinephrine Prophylaxis for Postspinal Anesthesia Hypotension in Parturients With Preeclampsia.

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Completed

Study Start Date

November 16, 2021 (Actual)

Primary Completion Date

June 6, 2023 (Actual)

Study Completion Date

June 6, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

General Hospital of Ningxia Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Adverse Effect

Keywords

Norepinephrine, Postspinal anesthesia hypotension, Preeclampsia, Cesarean section, Dose-finding

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

180 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control group

Arm Type

Placebo Comparator

Arm Description

Normal saline infusion simultaneous with subarachnoid block

Arm Title

0.025 μg/kg/min group

Arm Type

Experimental

Arm Description

A maintenance dose of norepinephrine (0.025 μg/kg/min) infusion simultaneous with subarachnoid block

Arm Title

0.050 μg/kg/min group

Arm Type

Experimental

Arm Description

A maintenance dose of norepinephrine (0.050 μg/kg/min) infusion simultaneous with subarachnoid block

Arm Title

0.075 μg/kg/min group

Arm Type

Experimental

Arm Description

A maintenance dose of norepinephrine (0.075 μg/kg/min) infusion simultaneous with subarachnoid block

Intervention Type

Drug

Intervention Name(s)

Normal saline

Other Intervention Name(s)

Intervention Description

Normal saline infusion simultaneous with subarachnoid block

Intervention Type

Drug

Intervention Name(s)

Norepinephrine

Other Intervention Name(s)

Vasopressors

Intervention Description

Different infusion dose of norepinephrine simultaneous with subarachnoid block

Primary Outcome Measure Information:

Title

The incidence of post-spinal anesthesia hypotension

Description

Systolic blood pressure (SBP) < 80% of the baseline

Time Frame

1-15 minutes after spinal anesthesia.

Secondary Outcome Measure Information:

Title

Overall stability of systolic blood pressure control versus baseline

Description

Evaluated by performance error (PE)

Time Frame