Intraoperative HypertensionNCT05252234
Post SARS-Cov-2 Disease Anesthesia Events
An observational study of Intraoperative Hypertension and Pain Threshold, run by Ain Shams University at 1 site in Egypt.
Trial summary
Estimating and recording the rate of occurrence of pulmonary and cardiovascular complications during the perioperative period in patients with past covid infection Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intraoperative Hypertension, Pain Threshold, Postoperative Pain
- What is being tested?
- Observation of hemodynamic status and post operative pain
- How many people
- 180 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2022to 30 Sep 2022
- Phase
- Observational
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Above 18 years undergoing surgery with past history of covid-19
Who may be able to join
- all patients above 18 years with past history of covid-19 during past 6 months undergoing surgery
Who cannot join
- hemodynamically unstable Patients requiring oxygen therapy
Trial locations and contacts
1 site in 1 country.
About this study
Estimating and recording the rate of occurrence of pulmonary and cardiovascular complications during the perioperative period in patients with past covid infection
- Being tested
- Observation of hemodynamic status and post operative pain
- Keywords
- SARS-Cov-2, Anesthesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation of hemodynamic status and post operative painOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients undergoing elective surgeries with past history of COVID-19 infection during the past six months Receives: Other: Observation of hemodynamic status and post operative pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of occurrence of pulmonary and cardiovascular complications
Measure all vital data and postoperative status
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start1 Apr 2022 (estimated)
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative HypertensionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr M Hilal Abdou, Ain Shams University
- Investigators
- Fathy Tash, MD, Study chair, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05252234
- Sponsor's protocol ID
- R 191/2021
- Status last verified
- Mar 2022
- First submitted
- 19 Feb 2022
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post SARS-Cov-2 Disease Anesthesia Events
- ClinicalTrials.gov ID
- NCT05252234
- Acronym / sponsor ID
- R 191/2021
- Keywords
- SARS-Cov-2, Anesthesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (estimated)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 23 Feb 2022 (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.
Estimating and recording the rate of occurrence of pulmonary and cardiovascular complications during the perioperative period in patients with past covid infection
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: Observation of hemodynamic status and post operative painPatients undergoing elective surgeries with past history of COVID-19 infection during the past six months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Above 18 years undergoing surgery with past history of covid-19
Key inclusion criteria (1 listed)
- all patients above 18 years with past history of covid-19 during past 6 months undergoing surgery
Key exclusion criteria (1 listed)
- hemodynamically unstable Patients requiring oxygen therapy
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 |
|---|---|---|
| Observation of hemodynamic status and post operative painNo intervention | Other | Group 1 |
Primary outcome
Rate of occurrence of pulmonary and cardiovascular complications
Time frame: 24 hours
Measure all vital data and postoperative status
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
- Individual participant dataSharing planned: Yes
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To Study Ocular Outflow Dynamics of the Eye Using Intraoperative Tonographic Biometry and Assess Its Predictive Value in Improving Postoperative Outcomes.
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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.
Fathy Tash, MD study chair
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intraoperative Hypertension and Pain Threshold, run by Ain Shams 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: status not confirmed, as of the sponsor's last update on 15 Mar 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amr M Hilal Abdou, MD (01001479037, Amr_hilal@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of occurrence of pulmonary and cardiovascular complications (time frame: 24 hours). 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 15 Mar 2022.