HypotensionPhase 2NCT04580342
Ivabradine Versus Propranolol for Induced Hypotension in Endoscopic Sinus Surgery
A Phase 2 study testing oral Ivabradine and oral Propranolol in people with Hypotension, run by Ahmed talaat ahmed aly at 1 site in Egypt.
Trial summary
the study is designed to compare the effect of addition of oral Ivabradine, propranolol to general anesthesia aimed reduction in blood loss during functional endoscopic sinus surgery. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hypotension
- What is being tested?
- oral Ivabradine and oral Propranolol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Oct 2020to 30 Jan 2021
- Phase
- Phase 2
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age of 18 - 60 years.
- Patients of both genders.
- ASA grade I - II .
Who cannot join
- Patient refusal.
- Any contraindication to medication included in the study .
- Patients with allergy to medication included in the study.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ahmed Talaat Ahmed
Asyut
Ahmed T Ahmed, A professor, 01062716629, talaat83@aun.edu.eg
Amal A Mohamed, 0102 175 9992, amalabdelnasser28@gmail.com
About this study
Official title: Comparative Study Between Oral Ivabradine Versus Oral Propranolol for Induced Hypotension in Functional Endoscopic Sinus Surgery
the study is designed to compare the effect of addition of oral Ivabradine, propranolol to general anesthesia aimed reduction in blood loss during functional endoscopic sinus surgery.
- Conditions
- Hypotension
- Being tested
- oral Ivabradine, oral Propranolol
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral IvabradineDrug
Ivabradine group will receive ivabradine 5mg PO in the evening and 1 hour before anesthetic induction
oral PropranololDrug
propranolol group will receive propranolol 10 mg PO in the evening and 1 hour before anesthetic induction.
| Study group | Role | What they receive |
|---|---|---|
| Ivabradine group | Experimental | Not described Receives: Drug: oral Ivabradine |
| propranolol group | Experimental | Not described Receives: Drug: oral Propranolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in blood loss
Estimated blood loss in millilitres per hour is calculated by subtracting the volume of total irrigation used during the case from the total amount of fluid in the suction canister at the end of surgery in addition, pre-weighing and post-weighing of sponges and oropharyngeal packs were also done and dividing by surgical time in hours.
assessment of blood loss by Boezaart and van der Merwe Grading System for bleeding during Endoscopic Sinus Surgery
Measured: immediately after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start15 Oct 2020 (estimated)
- Primary completion1 Jan 2021 (estimated)
- Study completion30 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypotensionStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahmed talaat ahmed aly
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmed talaat ahmed aly, Assiut University
- Investigators
- Ahmed T Ahmed, A professor, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04580342
- Sponsor's protocol ID
- ivabradine versus propranolol
- Status last verified
- Oct 2020
- First submitted
- 30 Sep 2020
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Oral Ivabradine Versus Oral Propranolol for Induced Hypotension in Functional Endoscopic Sinus Surgery
- ClinicalTrials.gov ID
- NCT04580342
- Acronym / sponsor ID
- ivabradine versus propranolol
- Conditions
- Hypotension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ahmed talaat ahmed alyUniversity, hospital or other
- Study start
- 15 Oct 2020 (estimated)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 30 Jan 2021 (estimated)
- First posted
- 8 Oct 2020 (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.
the study is designed to compare the effect of addition of oral Ivabradine, propranolol to general anesthesia aimed reduction in blood loss during functional endoscopic sinus surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ivabradine group | Experimental | Drug: oral Ivabradine |
| propranolol group | Experimental | Drug: oral Propranolol |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age of 18 - 60 years.
- Patients of both genders.
- ASA grade I - II .
Key exclusion criteria (3 listed)
- Patient refusal.
- Any contraindication to medication included in the study .
- Patients with allergy to medication included in the study.
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 |
|---|---|---|
| oral IvabradineIvabradine group will receive ivabradine 5mg PO in the evening and 1 hour before anesthetic induction | Drug | Ivabradine group |
| oral Propranololpropranolol group will receive propranolol 10 mg PO in the evening and 1 hour before anesthetic induction. | Drug | propranolol group |
Primary outcome
change in blood loss
Time frame: immediately after the surgery
Estimated blood loss in millilitres per hour is calculated by subtracting the volume of total irrigation used during the case from the total amount of fluid in the suction canister at the end of surgery in addition, pre-weighing and post-weighing of sponges and oropharyngeal packs were also done and dividing by surgical time in hours. assessment of blood loss by Boezaart and van der Merwe Grading System for bleeding during Endoscopic Sinus Surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Individual participant dataSharing planned: No
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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.
Ahmed T Ahmed, A professor principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing oral Ivabradine and oral Propranolol in people with Hypotension, run by Ahmed talaat ahmed aly 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 3 inclusion and 3 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 14 Oct 2020. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Ahmed T Ahmed, A professor (01062716629, talaat83@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in blood loss (time frame: immediately after the surgery). 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 14 Oct 2020.