Hypotension Drug-InducedPhase 4NCT05368376
Is Labetalol More Effective Than Metoprolol for Controlled Hypotensive Anesthesia During Endoscopic Nasal Surgeries?
A Phase 4 study testing Labetalol Hydrochloride Oral Tablet and Metoprolol Tartrate Oral Tablet in people with Hypotension Drug-Induced, run by Damanhour Teaching Hospital at 1 site in Egypt.
Trial summary
Background: Mucosal bleeding is the most frequent complication with endoscopic nasal surgeries, as it interferes with the optimal visualization of the intranasal anatomy, leading to increased complications, operation duration, and blood loss. 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?
- Labetalol Hydrochloride Oral Tablet and Metoprolol Tartrate 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 Apr 2021to 15 Oct 2022
- Phase
- Phase 4
- 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 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
- Body Mass Index (BMI) ≤ 35 kg/m2
Who cannot join
- ASA physical status > II
- Age < 21 years or > 50 years
- Pregnant women
- Breastfeeding
- Bronchial asthma
- Chronic obstructive pulmonary disease
Show all 24Show fewer
- 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
- Bleeding diathesis
- Diabetes Mellitus
- Allergic fungal sinusitis
- Patients on beta-blockers, tricyclic antidepressants, alcohol or drug abuse, anticoagulation therapy, agents influencing the autonomic nervous system
- Patients using pacemakers
- Allergy to the study drugs
- Any contraindication of oral intake
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Labetalol More Effective Than Metoprolol for Controlled Hypotensive Anesthesia During Endoscopic Nasal Surgeries? A Randomized Clinical Trial.
Background: Mucosal bleeding is the most frequent complication with endoscopic nasal surgeries, as it interferes with the optimal visualization of the intranasal anatomy, leading to increased complications, operation duration, and blood loss. There are several pharmacological techniques for the appropriate control of intraoperative bleeding.
Objectives: To compare the safety and efficacy of oral labetalol versus oral metoprolol as a premedication for controlled hypotensive anesthesia during endoscopic nasal surgeries.
Patients and Methods: This is a randomized, double-blind, phase four, comparative clinical trial; carried out on 60 patients, who were candidates for endoscopic nasal surgeries under general anesthesia at our hospital. Patients were randomly allocated into two equal groups; group L, received oral labetalol, and group M, received oral metoprolol.
- Conditions
- Hypotension Drug-Induced
- Being tested
- Labetalol Hydrochloride Oral Tablet, Metoprolol Tartrate Oral Tablet
- Keywords
- controlled hypotension, endoscopic nasal surgery, labetalol, metoprolol
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Labetalol Hydrochloride Oral TabletDrug
Also called Labipress tablets
Labetalol 200 mg
Metoprolol Tartrate Oral TabletDrug
Also called Betaloc tablets
Metoprolol 100 mg
| Study group | Role | What they receive |
|---|---|---|
| Group L (n=30) | Active comparator | Labetalol group Receives: Drug: Labetalol Hydrochloride Oral Tablet |
| Group M (n=30) | Active comparator | Metoprolol group Receives: Drug: Metoprolol Tartrate 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: 30 minutes after the end of surgery
Secondary outcomes (4)
Mean and Standard deviation of Sevoflurane concentration (%)(mean±SD)
Concentration of sevoflurane used during surgery
Measured: 30 minutes after the end of surgery
Mean and Standard deviation of Heart rate (beat/min.)(mean±SD)
Before premedication (T_B), 2 hours after premedication (T0), 1 minute after induction of anesthesia (T1), at 15 (T15), 30 (T30), 45 (T45), 60 (T60), 75 (T75) minutes after induction of anesthesia, at post anesthesia care unit (T_PACU)
Measured: 30 minutes after the end of surgery
Mean and Standard deviation of Mean Blood Pressure (mmHg)(mean±SD)
Before premedication (T_B), 2 hours after premedication (T0), 1 minute after induction of anesthesia (T1), at 15 (T15), 30 (T30), 45 (T45), 60 (T60), 75 (T75) minutes after induction of anesthesia, at post anesthesia care unit (T_PACU)
Measured: 30 minutes after the end of surgery
Number of participants and Percentage of Drug-related side effects
Number of participants and Rate of: Bradycardia, Hypotension, Dysrhythmia, Bronchospasm, and Postoperative nausea and vomiting (PONV)
Measured: 30 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 posted10 May 2022
- Study start1 Apr 2021
- Primary completion1 Oct 2022
- Study completion15 Oct 2022
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 (actual)
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
- NCT05368376
- Sponsor's protocol ID
- DTH: 22001
- Status last verified
- Sep 2021
- First submitted
- 5 May 2022
- Last updated
- 28 Sep 2023
- 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 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Labetalol More Effective Than Metoprolol for Controlled Hypotensive Anesthesia During Endoscopic Nasal Surgeries? A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT05368376
- Acronym / sponsor ID
- DTH: 22001
- Conditions
- Hypotension Drug-Induced
- Keywords
- controlled hypotension, endoscopic nasal surgery, labetalol, metoprolol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Damanhour Teaching HospitalOther government
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 15 Oct 2022 (actual)
- First posted
- 10 May 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.
Background: Mucosal bleeding is the most frequent complication with endoscopic nasal surgeries, as it interferes with the optimal visualization of the intranasal anatomy, leading to increased complications, operation duration, and blood loss. There are several pharmacological techniques for the appropriate control of intraoperative bleeding.
Objectives: To compare the safety and efficacy of oral labetalol versus oral metoprolol as a premedication for controlled hypotensive anesthesia during endoscopic nasal surgeries.
Patients and Methods: This is a randomized, double-blind, phase four, comparative clinical trial; carried out on 60 patients, who were candidates for endoscopic nasal surgeries under general anesthesia at our hospital. Patients were randomly allocated into two equal groups; group L, received oral labetalol, 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 L (n=30) | Active comparator | Drug: Labetalol Hydrochloride Oral TabletLabetalol group |
| Group M (n=30) | Active comparator | Drug: Metoprolol Tartrate Oral TabletMetoprolol group |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists (ASA) physical status ≤ II
- Age from 21 to 50 years
- Body Mass Index (BMI) ≤ 35 kg/m2
Key exclusion criteria (24 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 |
|---|---|---|
| Labetalol Hydrochloride Oral TabletAlso: Labipress tabletsLabetalol 200 mg | Drug | Group L (n=30) |
| Metoprolol Tartrate Oral TabletAlso: Betaloc tabletsMetoprolol 100 mg | Drug | Group M (n=30) |
Primary outcome
Mean and Standard deviation of Blood loss (ml)(mean±SD)
Time frame: 30 minutes after the end of surgery
Amount of blood loss at the end of surgery
4 secondary outcomes
Mean and Standard deviation of Sevoflurane concentration (%)(mean±SD)
Time frame: 30 minutes after the end of surgery
Mean and Standard deviation of Heart rate (beat/min.)(mean±SD)
Time frame: 30 minutes after the end of surgery
Mean and Standard deviation of Mean Blood Pressure (mmHg)(mean±SD)
Time frame: 30 minutes after the end of surgery
Number of participants and Percentage of Drug-related side effects
Time frame: 30 minutes after the end of surgery
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 28 Sep 2023.
Related trials for Hypotension Drug-Induced
RecruitingPhase 4
Premedication With Atenolol Versus Metoprolol for Controlled Hypotensive Anesthesia During Nasal Surgeries
Hypotension Drug-Induced
Not yet recruiting
Alveolar Recruitment Maneuver-Induced Hypotension: A Dynamic Consequence and Intraoperative Indicator of Fluid Responsiveness
Hypotension Drug-Induced, General Anesthesia Using Endotracheal Intubation
Not yet recruiting
Effect of Lateral Decubitus Position After Spinal Anesthesia on Hemodynamic Stability in High-Risk Geriatric Patients
Hypotension Drug-Induced, Spinal Aneshtesia
Recruiting
Hemodynamic Effects of Intravenous Paracetamol in Patients Undergoing Emergency Laparotomy
Paracetamol, Hypotension Drug-Induced
RecruitingPhase 2/3
Comparison of Supra vs Infra Inguinal Fascia Iliaca Blocks for Spinal Positioning and Analgesia in Lower Limb Surgery
Post Operative Analgesia, Bradycardia
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 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 Labetalol Hydrochloride Oral Tablet and Metoprolol Tartrate 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 3 inclusion and 24 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 28 Sep 2023. 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?
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?
Mean and Standard deviation of Blood loss (ml)(mean±SD) (time frame: 30 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 28 Sep 2023.