Phenylephrine Prophylaxis for Postspinal Anesthesia Hypot... | NCT04576663

Studies
Phenylephrine Prophylaxis for Postspinal Anesthesia Hypotension in Parturients With Preeclampsia

NCT04576663

Sponsor

General Hospital of Ningxia Medical University

Status

Unknown status

Last Update Posted

Nov 29, 2021Actual

Enrollment

95Estimated

Phase

Not Applicable

Conditions

Adverse Effect

Interventions

Normal saline
Phenylephrine

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2023Estimated

Primary Completion Date

Sep 21, 2025Estimated

Completion Date

Sep 21, 2025Estimated

First Submitted Date

Sep 30, 2020

First Submission Date that Met QC Criteria

Sep 30, 2020

First Posted Date

Oct 6, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 25, 2021

Last Update Posted Date

Nov 29, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to investigate the suitable infusion dose of phenylephrine 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. Practical guidelines for obstetric anesthesia from the American Society of Anesthesiologists and an international consensus statement on the management of hypotension with vasopressors indicate either IV ephedrine or phenylephrine may be used to correct hypotension. But the suitable infusion dose of phenylephrine in parturients with preeclampsia is still unknown. The purpose of this study is to investigate the suitable infusion dose of phenylephrine for prophylaxis against post-spinal anesthesia hypotension in parturients with preeclampsia undergoing cesarean section.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

95Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control group	Placebo Comparator	Normal saline infusion simultaneous with subarachnoid block	Drug: Normal saline
0.3125 μg/kg/min group	Experimental	A maintenance dose of phenylephrine (0.3125 μg/kg/ min) infusion simultaneous with subarachnoid block	Drug: Phenylephrine
0.625 μg/kg/min group	Experimental	A maintenance dose of phenylephrine (0.625 μg/kg/ min) infusion simultaneous with subarachnoid block	Drug: Phenylephrine
0.9375 μg/kg/min group	Experimental	A maintenance dose of phenylephrine (0.9375 μg/kg/ min) infusion simultaneous with subarachnoid block	Drug: Phenylephrine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Normal saline	Drug	Normal saline infusion simultaneous with subarachnoid block	Control group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The incidence of post-spinal anesthesia hypotension	Systolic blood pressure (SBP) < 80% of the baseline	1-15 minutes after spinal anesthesia

Secondary Outcomes

Measure	Description	Time Frame
Overall stability of systolic blood pressure control versus baseline	Evaluated by performance error (PE)	1-15 minutes after spinal anesthesia
Overall stability of heart rate control versus baseline

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xinli Ni, Dr.	Contact	86-951-674-3252		xinlini6@nyfy.com.cn
Yi Chen, M.D.	Contact	86-951-674-3252		czzyxgp@163.com

Overall Officials

Name	Affiliation	Role
Xinli Ni, Dr.	Hospital of Ningxia Medical University	Study Chair

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011225	Pre-Eclampsia

Ancestor Terms

ID	Term
D046110	Hypertension, Pregnancy-Induced
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077330	Saline Solution
D010656	Phenylephrine
D014662	Vasoconstrictor Agents

Ancestor Terms

ID	Term
D000077324	Crystalloid Solutions
D007552	Isotonic Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations

Browse Leaves

Not provided

Browse Branches

Not provided