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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04758286
Recruitment Status : Completed
First Posted : February 17, 2021
Last Update Posted : February 17, 2021
Sponsor:
Collaborator:
Tanta University
Information provided by (Responsible Party):
Adel F. Alkholy, Benha University

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

Condition or disease Intervention/treatment Phase
COVID-19 Procedure: Emergency surgical procedures Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 209 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: All patients presenting with surgical emergency
Masking: Single (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
Primary Purpose: Treatment
Official Title: Protocol for Anesthesia for Emergency Surgery
Actual Study Start Date : July 1, 2020
Actual Primary Completion Date : February 1, 2021
Actual Study Completion Date : February 11, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
  • Epidural anesthesia
  • Total intravenous 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
  • Epidural anesthesia
  • Total intravenous anesthesia


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Physiologic assessment [ Time Frame: Up to one day ]
    estimation of systolic and diastolic blood pressures of patients during and after surgery

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Assured diagnosis of COVID-19 by RT-PCR

Exclusion Criteria:

  • No
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04758286


Locations
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Egypt
Faculty of Medicine
Banhā, Qalubia, Egypt, 0013
Sponsors and Collaborators
Benha University
Tanta University
Investigators
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Principal Investigator: Adel Alkholy, Prof Faculty of Medicine, Banha University, Egypt
More Information
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Responsible Party: Adel F. Alkholy, Professor of Medical Biochemistry, Benha University
ClinicalTrials.gov Identifier: NCT04758286    
Other Study ID Numbers: RC2-2-2021
First Posted: February 17, 2021    Key Record Dates
Last Update Posted: February 17, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The study protocol may be shared
Supporting Materials: Study Protocol
Time Frame: after publishing
Access Criteria: email

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Adel F. Alkholy, Benha University:
COVID-19
Anesthesia
Surgery
Outcomes
Additional relevant MeSH terms:
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COVID-19
Emergencies
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
 Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs