Perfusion Index Predicts Post-spinal Hypotension in Obese... | NCT04186091

Studies
Perfusion Index Predicts Post-spinal Hypotension in Obese Parturients for Cesarean Section

NCT04186091

Sponsor

Cairo University

Status

Completed

Last Update Posted

Dec 4, 2019Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Perfusion Index Predicts Post-spinal Hypotension

Interventions

correlation between baseline perfusion index and decrease in systolic blood pressure post spinal induction

Countries

Egypt

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

Dec 2019

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

Apr 1, 2017Actual

Primary Completion Date

Jul 9, 2018Actual

Completion Date

Jul 30, 2018Actual

First Submitted Date

Dec 1, 2019

First Submission Date that Met QC Criteria

Dec 3, 2019

First Posted Date

Dec 4, 2019Actual

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

Dec 3, 2019

Last Update Posted Date

Dec 4, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Hypotension is a common adverse effect of spinal anesthesia during caesarean section especially in obese patients.

The aim of this study is to find out the correlation between baseline PI and post spinal hypotension in obese parturient.

Detailed Description

Abstract Background Hypotension is a common adverse effect of spinal anesthesia during caesarean section especially in obese patients.

The aim of this study is to find out the correlation between baseline PI and post spinal hypotension in obese parturient.

Methods After approval of ethical committee and written informed consent, fifty Parturients aged between 18- 40 years, ASA I and II with term singleton pregnancies with BMI between 25 &40 admitted for cesarean section under spinal anesthesia were recruited in this prospective, observational study. The primary outcome is the correlation between baseline perfusion index and post spinal hypotension. The secondary outcome is the correlation between BMI and the incidence of hypotension after spinal anesthesia. Heart rate, blood pressure, perfusion index before and after spinal induction using Masimo device, level of sensory block, dose of ephedrine required to correct hypotension, dose of atropine required to correct bradycardia, incidence of nausea, vomiting and shivering were recorded.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
correlation between baseline perfusion index and decrease in systolic blood pressure post spinal induction	Procedure	correlation between baseline perfusion index and decrease in systolic blood pressure post spinal induction

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
correlation between baseline perfusion index and post spinal decrease in systolic blood pressure	correlation between baseline perfusion index and post spinal decrease in systolic blood pressure	24 hours Postoperative

Secondary Outcomes

Measure	Description	Time Frame
correlation between BMI and the incidence of post-spinal hypotension	correlation between BMI and the incidence of post-spinal hypotension	24 hours Postoperative

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Fifty parturient
Aged between 18- 40,
ASA I and II
With term singleton pregnancies
With 25 ≥ BMI≤ 40
Conducted for cesarean section under spinal anesthesia

Exclusion Criteria:

Emergency cases,
Placenta previa,
Preeclampsia,
Cardiovascular and cerebrovascular diseases,
Patient with contraindication for regional anesthesia
Patient with peripheral vascular diseases as DVT.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

After approval of ethical committee and written informed consent, fifty Parturients aged between 18- 40 years, ASA I and II with term singleton pregnancies with BMI between 25 &40 admitted for cesarean section under spinal anesthesia were recruited in this prospective, observational study. The primary outcome is the correlation between baseline perfusion index and post spinal hypotension. The secondary outcome is the correlation between BMI and the incidence of hypotension after spinal anesthesia. Heart rate, blood pressure, perfusion index before and after spinal induction using Masimo device, level of sensory block, dose of ephedrine required to correct hypotension, dose of atropine required to correct bradycardia, incidence of nausea, vomiting and shivering were recorded.

Sampling Method

Probability Sample

Name	Affiliation	Role
Ahmed Abdalla Mohamed, M.D	Cairo University	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Ahmed Abdalla Mohamed		Cairo		11451	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Till submission

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided