Norepinephrine Versus Ephedrin for Prevention of Post Spi... | NCT03719625

Studies
Norepinephrine Versus Ephedrin for Prevention of Post Spinal Anesthesia in Cesarean Section

NCT03719625

Sponsor

Mongi Slim Hospital

Status

Unknown status

Last Update Posted

Dec 3, 2018Actual

Enrollment

200Estimated

Phase

Phase 4

Conditions

Maternal Hypotension Syndrome
Cesarean

Interventions

Ephedrine
Norepinephrine

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

Oct 2018

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

Jan 2, 2019Estimated

Primary Completion Date

May 30, 2019Estimated

Completion Date

May 30, 2019Estimated

First Submitted Date

Oct 19, 2018

First Submission Date that Met QC Criteria

Oct 23, 2018

First Posted Date

Oct 25, 2018Actual

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 30, 2018

Last Update Posted Date

Dec 3, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mhamed Sami Mebazaa, Head of the anesthesia intensive care department, Mongi Slim HospitalPrincipal Investigator

Lead Sponsor

Mongi Slim HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this study is to compare the efficency and the safety of norepinephrin and ephedrin prophylactic administration to reduce the incidence of post spinal hypotension in cesarean section.

Detailed Description

Spinal anesthesia is still the gold standard anesthetic method for elective and urgent cesarean section, the post spinal hypotension remains the most frequent complication of this procedure and is still responsible of considerable maternel and fetal morbidity. It is recommanded to prevent this post spinal hypotension with fluid coloading and prophylactic vasopressors administration. The prophylactic use of norepinephrin and phenylephrin has been validated by several studies, but few data are published concerning the comparaison between norepinephrin and ephedrine as preventive vasopressors in cesarean section; these molecules act on alpha and beta adrenergic receptors and could provide better maternal hemodynamics in parturients undergoing cesarean section under spinal anesthesia.

The aim of this study is to compare the efficency and the safety of norepinephrin and ephedrin prophylactic administration to reduce the incidence of post spinal hypotension in 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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
norepinephrin group	Experimental	The patients of this group will recieve 0.5 micro gr/kg of norepinephin intravenously, the infusion will start during the intrathecal injection and during 10 minutes	Drug: Norepinephrine
Ephedrin group	Experimental	The patients of this group will recieve 0,3mg/kg of Ephedrin intravenously, the infusion will start during the intrathecal injection and during 10 minutes	Drug: Ephedrine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ephedrine	Drug	Comparaison of Norepinephrin and Ephedrin for prevention of the post spinal anesthesia in cesarean section	Ephedrin group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of post spinal hypotension	decrease of systolic arterial blood pressure > 20% baseline	during the first 20 minutes after spinal anesthesia

Secondary Outcomes

Measure	Description	Time Frame
Lowest systolic blood pressure	Lowest systolic blood pressure recorded after spinal anesthesia	uring the first 20 minutes after spinal anesthesia
Incidence of bradycardia	heart rate<50 beats/min

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

full termed parturients scheduled for elective or semi urgent cesarean section under spinal anesthesia
AGE>15 years
ASA II status
No history of hypertension, preeclampsia or cardiopathy
BMI<40

Exclusion Criteria:

cesarean section under genearl anesthesia or epidural analgesia during labor

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

this study is exclusively including paturients undergoing cesarean section

Minimum Age

15 Years

Maximum Age

45 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Asma Ben Souissi, assistant professor	Contact	0021698336883		bsouissiasma@gmail.com
Mhamed Sami Mebazaa, Professor	Contact	0021622252589		msmebazaa@gmail.com

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004809	Ephedrine
D009638	Norepinephrine

Ancestor Terms

ID	Term
D011412	Propanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals

Browse Leaves

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Browse Branches

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