Post SARS-Cov-2 Disease Anesthesia Events | NCT05252234

Studies
Post SARS-Cov-2 Disease Anesthesia Events

NCT05252234

Sponsor

Ain Shams University

Status

Unknown status

Last Update Posted

Mar 15, 2022Actual

Enrollment

180Estimated

Phase

Not provided

Conditions

Intraoperative Hypertension
Pain Threshold
Postoperative Pain
Postoperative Hypoxemia

Interventions

Observation of hemodynamic status and post operative pain

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

Mar 2022

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

Apr 1, 2022Estimated

Primary Completion Date

Jun 30, 2022Estimated

Completion Date

Sep 30, 2022Estimated

First Submitted Date

Feb 19, 2022

First Submission Date that Met QC Criteria

Feb 19, 2022

First Posted Date

Feb 23, 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

Mar 12, 2022

Last Update Posted Date

Mar 15, 2022Actual

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Estimating and recording the rate of occurrence of pulmonary and cardiovascular complications during the perioperative period in patients with past covid infection

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

180Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1		Patients undergoing elective surgeries with past history of COVID-19 infection during the past six months	Other: Observation of hemodynamic status and post operative pain

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Observation of hemodynamic status and post operative pain	Other	No intervention	Group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of occurrence of pulmonary and cardiovascular complications	Measure all vital data and postoperative status	24 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all patients above 18 years with past history of covid-19 during past 6 months undergoing surgery

Exclusion Criteria:

hemodynamically unstable Patients requiring oxygen therapy

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Above 18 years undergoing surgery with past history of covid-19

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Amr M Hilal Abdou, MD	Contact	01001479037		Amr_hilal@med.asu.edu.eg

Overall Officials

Name	Affiliation	Role
Fathy Tash, MD	Ain Shams University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of medicine, Ain Shams University		Cairo			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)

Time Frame

6 months

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided