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

February 16, 2021 updated by: Adel F. Alkholy, Benha University

Protocol for Anesthesia for Emergency Surgery

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

209

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Qalubia
      • Banhā, Qalubia, Egypt, 0013
        • Faculty of medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Assured diagnosis of COVID-19 by RT-PCR

Exclusion Criteria:

  • No

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Successful outcome
It will include the anesthetic and operative data and the incidence of intraoperative or postoperative complication
Procedure: Emergency surgical procedures
COVID-19 patients who had presented to the Emergency Department were evaluated for their emergency surgical conditions and were managed appropriately
Other Names:
  • Spinal anesthesia
  • Total intravenous anesthesia
  • Epidural anesthesia
Active Comparator: Complicated outcome
It will include the anesthetic and operative data and the incidence of intraoperative or postoperative complication
Procedure: Emergency surgical procedures
COVID-19 patients who had presented to the Emergency Department were evaluated for their emergency surgical conditions and were managed appropriately
Other Names:
  • Spinal anesthesia
  • Total intravenous anesthesia
  • Epidural anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Questionnaire
Time Frame: Up to two days
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
Up to two days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physiologic assessment
Time Frame: Up to one day
estimation of systolic and diastolic blood pressures of patients during and after surgery
Up to one day
Surgical follow-up
Time Frame: Up to 10 days
Postoperative assessment of wounds and drainage tube, if any, and to determine the success of the procedure or the development of complications
Up to 10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benha University

Collaborators

Tanta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2020

Primary Completion (Actual)

February 1, 2021

Study Completion (Actual)

February 11, 2021

Study Registration Dates

First Submitted

February 11, 2021

First Submitted That Met QC Criteria

February 16, 2021

First Posted (Actual)

February 17, 2021

Study Record Updates

Last Update Posted (Actual)

February 17, 2021

Last Update Submitted That Met QC Criteria

February 16, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC2-2-2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The study protocol may be shared

IPD Sharing Time Frame

after publishing

IPD Sharing Access Criteria

email

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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