Hypotension Drug-InducedPhase 4NCT04914234
Premedication With Atenolol Versus Metoprolol for Controlled Hypotensive Anesthesia During Nasal Surgeries
A Phase 4 study testing Atenolol Succinate Oral Tablet and Metoprolol Succinate Oral Tablet in people with Hypotension Drug-Induced, run by Damanhour Teaching Hospital at 1 site in Egypt.
Trial summary
Objectives: To compare the safety and efficacy of oral atenolol versus oral metoprolol as a premedication for controlled hypotensive anesthesia during nasal surgeries. Background: Mucosal bleeding is the most frequent complication with nasal surgeries, as it interferes with the optimal visualization of the intranasal… Read more about this study
- Who is it for?
- Ages 21 to 50 years
- Conditions the study is for
- Hypotension Drug-Induced
- What is being tested?
- Atenolol Succinate Oral Tablet and Metoprolol Succinate Oral Tablet
- 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
- 1 Dec 2025to 30 Jan 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 21 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status ≤ II
- Age from 21 to 50 years
Who cannot join
- ASA physical status > II
- Age < 21 years or > 50 years
- Pregnant women
- Breastfeeding
- Bronchial asthma
- Chronic obstructive pulmonary disease
Show all 26Show fewer
- Diabetes Mellitus
- Hypertension
- Ischemic heart disease
- Rheumatic heart disease
- Heart failure
- Heart block
- Sick sinus syndrome
- Sinus bradycardia
- Chronic hypotension
- Anemia (Hb < 10 g/dl)
- Renal or hepatic dysfunction
- Central nervous system disease
- Allergic fungal sinusitis
- Patients on beta-blockers
- Alcohol or drug abuse
- Anticoagulation therapy,
- Bleeding diathesis
- Agents influencing autonomic nervous system
- Allergy to the study drugs
- Any contraindication of oral intake
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Damanhour Teaching Hospital
Damanhūr, El-Beheira
Ahmed M Shaat, MD, 00201223482709, ahmedshaat99@gmail.com
About this study
Official title: Premedication With Atenolol Versus Metoprolol for Controlled Hypotensive Anesthesia During Nasal Surgeries. A Randomized Clinical Trial
Objectives: To compare the safety and efficacy of oral atenolol versus oral metoprolol as a premedication for controlled hypotensive anesthesia during nasal surgeries.
Background: Mucosal bleeding is the most frequent complication with nasal surgeries, as it interferes with the optimal visualization of the intranasal anatomy, increases operation time, and consequently increases blood loss. There are several pharmacological and non-pharmacological techniques for the appropriate control of intraoperative bleeding.
Patients and Methods: This was a prospective, randomized, double-blind, phase four, comparative clinical trial; carried out on 60 patients, who were candidates for nasal surgeries under general anesthesia at our hospital. Patients were randomly allocated into two equal groups; group A, received oral atenolol, and group M, received oral metoprolol.
- Conditions
- Hypotension Drug-Induced
- Being tested
- Atenolol Succinate Oral Tablet, Metoprolol Succinate Oral Tablet
- Keywords
- atenolol, controlled hypotension, metoprolol, nasal surgery
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atenolol Succinate Oral TabletDrug
Also called Tenormin tablets
Atenolol 50 mg
Metoprolol Succinate Oral TabletDrug
Also called Seloken ZOC tablets
Metoprolol 100 mg
| Study group | Role | What they receive |
|---|---|---|
| Group A (n=30) | Active comparator | Atenolol group Receives: Drug: Atenolol Succinate Oral Tablet |
| Group M (n=30) | Active comparator | Metoprolol group Receives: Drug: Metoprolol Succinate Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean and Standard deviation of Blood loss (ml)(mean±SD)
Amount of blood loss at the end of surgery
Measured: 5 minutes after the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study start1 Dec 2025
- Primary completion15 Jan 2027 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypotension Drug-InducedStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Damanhour Teaching Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ahmed M Shaat, MD, Principal investigator, Damanhour Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04914234
- Sponsor's protocol ID
- DTH: 21002
- Status last verified
- May 2026
- First submitted
- 31 May 2021
- Last updated
- 21 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Premedication With Atenolol Versus Metoprolol for Controlled Hypotensive Anesthesia During Nasal Surgeries. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04914234
- Acronym / sponsor ID
- DTH: 21002
- Conditions
- Hypotension Drug-Induced
- Keywords
- atenolol, controlled hypotension, metoprolol, nasal surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Damanhour Teaching HospitalOther government
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 4 Jun 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.
Objectives: To compare the safety and efficacy of oral atenolol versus oral metoprolol as a premedication for controlled hypotensive anesthesia during nasal surgeries.
Background: Mucosal bleeding is the most frequent complication with nasal surgeries, as it interferes with the optimal visualization of the intranasal anatomy, increases operation time, and consequently increases blood loss. There are several pharmacological and non-pharmacological techniques for the appropriate control of intraoperative bleeding.
Patients and Methods: This was a prospective, randomized, double-blind, phase four, comparative clinical trial; carried out on 60 patients, who were candidates for nasal surgeries under general anesthesia at our hospital. Patients were randomly allocated into two equal groups; group A, received oral atenolol, and group M, received oral metoprolol.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (n=30) | Active comparator | Drug: Atenolol Succinate Oral TabletAtenolol group |
| Group M (n=30) | Active comparator | Drug: Metoprolol Succinate Oral TabletMetoprolol group |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) physical status ≤ II
- Age from 21 to 50 years
Key exclusion criteria (26 listed)
- ASA physical status > II
- Age < 21 years or > 50 years
- Pregnant women
- Breastfeeding
- Bronchial asthma
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 |
|---|---|---|
| Atenolol Succinate Oral TabletAlso: Tenormin tabletsAtenolol 50 mg | Drug | Group A (n=30) |
| Metoprolol Succinate Oral TabletAlso: Seloken ZOC tabletsMetoprolol 100 mg | Drug | Group M (n=30) |
Primary outcome
Mean and Standard deviation of Blood loss (ml)(mean±SD)
Time frame: 5 minutes after the end of surgery
Amount of blood loss at the end of surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
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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.
Ahmed M Shaat, MD principal investigator
Damanhour Teaching Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atenolol Succinate Oral Tablet and Metoprolol Succinate Oral Tablet in people with Hypotension Drug-Induced, run by Damanhour Teaching Hospital 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 2 inclusion and 26 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: looking for participants now, as of the sponsor's last update on 21 Sep 2026. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed M Shaat, MD (00201223482709, ahmedshaat99@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean and Standard deviation of Blood loss (ml)(mean±SD) (time frame: 5 minutes after the end of 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 21 Sep 2026.