Effectiveness of Prophylactic Bolus Ephedrine Versus Nore... | NCT05522088

Studies
Effectiveness of Prophylactic Bolus Ephedrine Versus Norepinephrine for Management of Post Spinal Hypotension

NCT05522088

Sponsor

Wachemo University

Status

Completed

Last Update Posted

Aug 30, 2022Actual

Enrollment

84Actual

Phase

Not provided

Conditions

Comparing Ephedrine With Norepinephrine for Mangement Postspinal Hypotension

Interventions

Not provided

Countries

Ethiopia

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

Aug 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2022Actual

Primary Completion Date

Apr 30, 2022Actual

Completion Date

Apr 30, 2022Actual

First Submitted Date

Aug 25, 2022

First Submission Date that Met QC Criteria

Aug 26, 2022

First Posted Date

Aug 30, 2022Actual

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

Aug 26, 2022

Last Update Posted Date

Aug 30, 2022Actual

Description Module

Brief Summary

This study was conducted to compare the effectiveness of ephedrine versus norepinephrine for management of hypotension after spinal anesthesia for mothers undergoing elective cesarean section

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

84Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
to compare mean blood pressure (MAP) between the groups		From March,01 to April, 30/2022

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ASA class II and ages ranging from 18-35 years were included in the study

Exclusion Criteria:

pregnant women with preeclampsia/eclampsia, baseline hypertension (SBP> 140 mm Hg), BMI> 30 kg/m2, failed spinal, spinal anaesthesia converted to general anaesthesia, contraindication for spinal anaesthesia and mother with cardiovascular, renal or hepatic disease.

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

All pregnant women undergoing elective cesarean section fulfills the inclusion criteria were the source population

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Wachemo University		Hosa’ina			Ethiopia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36225250	Derived	Desalegn M, Shitemaw T, Tamrat H. Effectiveness of Prophylactic Bolus Ephedrine Versus Norepinephrine for Management of Postspinal Hypotension during Elective Caesarean Section in Resource Limited Setting: A Prospective Cohort Study. Anesthesiol Res Pract. 2022 Oct 3;2022:7170301. doi: 10.1155/2022/7170301. eCollection 2022.