COVID-19NCT04758286
Anesthetic & Surgical Protocol for Emergency Surgeries During the Era of COVID-19
A study testing Emergency surgical procedures in people with COVID-19, run by Benha University at 1 site in Egypt.
Trial summary
A protocol applied during anesthesia and surgical interventions for patients with emergency surgical conditions during the era of COVID-19 disease Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID-19
- What is being tested?
- Emergency surgical procedures
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 209 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2020to 11 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Assured diagnosis of COVID-19 by RT-PCR
Who cannot join
- No
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- COVID-19
- Being tested
- Emergency surgical procedures
- Keywords
- COVID-19, Anesthesia, Surgery, Outcomes
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emergency surgical proceduresProcedure or surgery
Also called Spinal anesthesia, Epidural anesthesia, Total intravenous anesthesia
COVID-19 patients who had presented to the Emergency Department were evaluated for their emergency surgical conditions and were managed appropriately
| Study group | Role | What they receive |
|---|---|---|
| Successful outcome | Active comparator | It will include the anesthetic and operative data and the incidence of intraoperative or postoperative complication Receives: Procedure: Emergency surgical procedures |
| Complicated outcome | Active comparator | It will include the anesthetic and operative data and the incidence of intraoperative or postoperative complication Receives: Procedure: Emergency surgical procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to two days
Secondary outcomes (2)
Physiologic assessment
estimation of systolic and diastolic blood pressures of patients during and after surgery
Measured: Up to one day
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
Measured: Up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start1 Jul 2020
- Primary completion1 Feb 2021
- Study completion11 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- All patients presenting with surgical emergency
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Collaborators
- Tanta University
- Responsible party
- Principal investigator, Adel F. Alkholy, Benha University
- Investigators
- Adel Alkholy, Prof, Principal investigator, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04758286
- Sponsor's protocol ID
- RC2-2-2021
- Status last verified
- Feb 2021
- First submitted
- 11 Feb 2021
- Last updated
- 17 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol may be shared
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for Anesthesia for Emergency Surgery
- ClinicalTrials.gov ID
- NCT04758286
- Acronym / sponsor ID
- RC2-2-2021
- Conditions
- COVID-19
- Keywords
- COVID-19, Anesthesia, Surgery, Outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Collaborators
- Tanta University
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 11 Feb 2021 (actual)
- First posted
- 17 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- All patients presenting with surgical emergency
| Arm | Type | Receives |
|---|---|---|
| Successful outcome | Active comparator | Procedure: Emergency surgical proceduresIt will include the anesthetic and operative data and the incidence of intraoperative or postoperative complication |
| Complicated outcome | Active comparator | Procedure: Emergency surgical proceduresIt will include the anesthetic and operative data and the incidence of intraoperative or postoperative complication |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Assured diagnosis of COVID-19 by RT-PCR
Key exclusion criteria (1 listed)
- No
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emergency surgical proceduresAlso: Spinal anesthesia, Epidural anesthesia, Total intravenous anesthesiaCOVID-19 patients who had presented to the Emergency Department were evaluated for their emergency surgical conditions and were managed appropriately | Procedure or surgery | Complicated outcome, Successful outcome |
Primary outcome
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
2 secondary outcomes
Physiologic assessment
Time frame: Up to one day
Surgical follow-up
Time frame: Up to 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2021.
- Individual participant dataSharing planned: Yes. The study protocol may be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adel Alkholy, Prof principal investigator
Benha University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emergency surgical procedures in people with COVID-19, run by Benha University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaire (time frame: Up to two days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2021.