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Anesthetic & Surgical Protocol for Emergency Surgeries During the Era of COVID-19

Primary Purpose

COVID-19

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Emergency surgical procedures

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring COVID-19, Anesthesia, Surgery, Outcomes

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Assured diagnosis of COVID-19 by RT-PCR

Exclusion Criteria:

Sites / Locations

Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Successful outcome

Complicated outcome

Arm Description

It will include the anesthetic and operative data and the incidence of intraoperative or postoperative complication

Outcomes

Primary Outcome Measures

Questionnaire

This questionnaire was designed to assess the satisfaction of the anesthetist in-charge and the surgeon by the applied protocol to manage COVID-19 patients

Secondary Outcome Measures

Physiologic assessment

estimation of systolic and diastolic blood pressures of patients during and after surgery

Surgical follow-up

Postoperative assessment of wounds and drainage tube, if any, and to determine the success of the procedure or the development of complications

Full Information

NCT ID

NCT04758286

First Posted

February 11, 2021

Last Updated

February 16, 2021

Sponsor

Benha University

Collaborators

Tanta University

1. Study Identification

Unique Protocol Identification Number

NCT04758286

Brief Title

Anesthetic & Surgical Protocol for Emergency Surgeries During the Era of COVID-19

Official Title

Protocol for Anesthesia for Emergency Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

July 1, 2020 (Actual)

Primary Completion Date

February 1, 2021 (Actual)

Study Completion Date

February 11, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Benha University

Collaborators

Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

A protocol applied during anesthesia and surgical interventions for patients with emergency surgical conditions during the era of COVID-19 disease

Detailed Description

All COVID-19 patients who were admitted to emergency departments presenting with emergency surgical conditions were evaluated for assurance of having COVID-19 disease. Then, the appropriate anesthetic procedure was applied and the appropriate surgical intervention was performed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19

Keywords

COVID-19, Anesthesia, Surgery, Outcomes

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

All patients presenting with surgical emergency

Masking

Outcomes Assessor

Masking Description

An anesthetist who was not in charge for application of the protocol is responsible for assessing the intraoperative findings and another anesthetist was responsible for assessing the postoperative findings

Allocation

Non-Randomized

Enrollment

209 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Successful outcome

Arm Type

Active Comparator

Arm Description

It will include the anesthetic and operative data and the incidence of intraoperative or postoperative complication

Arm Title

Complicated outcome

Arm Type

Active Comparator

Arm Description

It will include the anesthetic and operative data and the incidence of intraoperative or postoperative complication

Intervention Type

Procedure

Intervention Name(s)

Emergency surgical procedures

Other Intervention Name(s)

Spinal anesthesia, Epidural anesthesia, Total intravenous anesthesia

Intervention Description

COVID-19 patients who had presented to the Emergency Department were evaluated for their emergency surgical conditions and were managed appropriately

Primary Outcome Measure Information:

Title

Questionnaire

Description

This questionnaire was designed to assess the satisfaction of the anesthetist in-charge and the surgeon by the applied protocol to manage COVID-19 patients

Time Frame

Up to two days

Secondary Outcome Measure Information:

Title

Physiologic assessment

Description

estimation of systolic and diastolic blood pressures of patients during and after surgery

Time Frame

Up to one day

Title

Surgical follow-up

Description

Postoperative assessment of wounds and drainage tube, if any, and to determine the success of the procedure or the development of complications

Time Frame

Up to 10 days

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Assured diagnosis of COVID-19 by RT-PCR Exclusion Criteria: No

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Adel Alkholy, Prof

Organizational Affiliation

Faculty of Medicine, Banha University, Egypt

Official's Role

Principal Investigator

Facility Information:

Facility Name

Faculty of Medicine

City

Banhā

State/Province

Qalubia

ZIP/Postal Code

0013

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

The study protocol may be shared

IPD Sharing Time Frame

after publishing

IPD Sharing Access Criteria

Learn more about this trial

Anesthetic & Surgical Protocol for Emergency Surgeries During the Era of COVID-19

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