Hypotensive AnesthesiaPhase 4NCT06752863
Labetalol Infusion and Dexmedetomidine Infusion in Hypotensive Anesthesia
A Phase 4 study testing Hypotensive anesthesia in ear, nose and throat surgeries using labetalol and dexmedetomidine infusions in people with Hypotensive Anesthesia and Ear, Nose and Throat Procedure, run by Ain Shams University at 1 site in Egypt.
Trial summary
this study aims to compare between the role of Labetalol infusion versus Dexmedetomidine infusion in hypotensive anesthesia in Ear, Nose and Throat surgeries. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Hypotensive Anesthesia, Ear, Nose and Throat Procedure
- What is being tested?
- Hypotensive anesthesia in ear, nose and throat surgeries using labetalol and dexmedetomidine infusions
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 27 Nov 2024to Dec 2025
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists I, II (ASA I, II) patients who were candidate for Ear, Nose and Throat surgeries.
- Age: between 20 and 50 years
Who cannot join
- Patients with uncontrolled hypertension, variable degrees of heart block, congestive cardiac failure, coagulopathy, cerebral insufficiency, hepatic or renal abnormality
- Patients on beta blocker or clonidine
- Pregnant or lactating females
- Patients who were allergic to any of the anesthetic or hypotensive drugs used in the study
- Patient refusal to be included in the trial
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams university
Cairo, Cairo Governorate, 11517
Nourhan Osama, Master degree
About this study
Official title: Comparative Study of Labetalol Infusion Versus Dexmedetomidine Infusion in Hypotensive Anesthesia in Ear, Nose and Throat Surgeries
this study aims to compare between the role of Labetalol infusion versus Dexmedetomidine infusion in hypotensive anesthesia in Ear, Nose and Throat surgeries.
Read the detailed description
Hypotensive anaesthesia is the deliberate lowering of a patient's blood pressure during surgery. It is necessary during ear, nose and throat surgery for drying surgical field, ease in operation procedure and shortening of the duration of surgery. Labetalol is a unique parenteral anti-hypertensive drug that has selective α1 and non- selective β adrenergic antagonist effects. In humans, the β to α blocking potency ratio is 7: 1 for IV labetalol. Dexmedetomidine is highly selective alpha2 adrenergic agonist having several beneficial actions during the perioperative period. Activation of alpha2 adrenergic receptors in the brain and spinal cord inhibits neuronal firing causing hypotension and bradycardia. This study was designed to compare between the role of Labetalol infusion versus Dexmedetomidine infusion in hypotensive anesthesia in Ear, Nose and Throat surgeries.
- Being tested
- Hypotensive anesthesia in ear, nose and throat surgeries using labetalol and dexmedetomidine infusions
- Keywords
- Hypotensive anesthesia, Labetalol, Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypotensive anesthesia in ear, nose and throat surgeries using labetalol and dexmedetomidine infusionsDrug
The study compares the role of Labetalol infusion versus Dexmedetomidine infusion in hypotensive anesthesia in patients having ear, nose and throat surgeries
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing ear, nose and throat surgeries who will receive dexmedetomidine infusion | Active comparator | Dexmedetomidine group: the patients will receive deliberate hypotensive anesthesia with dexmedetomidine infusion (precedex ® 200 μg/2 ml; Hospira, Inc., Rocky Mount, USA) via syringe pump by adding 200 mcg (2ml) of dexmedetomidine to 48 ml of normal saline (final concentration of 4 mcg/ml) The patients will receive a loading dose of 1mcg/kg intravenously followed by an infusion of 0.7 mcg/kg/hour as maintenance dose. Receives: Drug: Hypotensive anesthesia in ear, nose and throat surgeries using labetalol and dexmedetomidine infusions |
| Patients undergoing ear, nose and throat surgeries who will receive Labetalol infusion | Active comparator | Labetalol groups: the patients will receive deliberate hypotensive anesthesia with labetalol infusion (Labipress 100mg/20ml; Al Debeiky pharma(DBK) pharmaceutical co., Cairo, Egypt) via syringe pump by adding 100 mg (20ml) of Labetalol to 30ml of normal saline (final concentration of 2 mg/ml) The patients will receive a loading dose of 0.4mg/kg intravenously followed by an infusion of 0.04mg/kg/hour as maintenance dose. Receives: Drug: Hypotensive anesthesia in ear, nose and throat surgeries using labetalol and dexmedetomidine infusions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean arterial blood pressure changes before induction of anesthesia & every 15 min throughout deliberate hypotension
Measured: 12 months
Secondary outcomes (4)
Heart rate changes before induction of anesthesia and every 15 min
Measured: 12 months
Surgical site oligaemia will be evaluated by the surgeons by rating the amount of bleeding according to Modena bleeding score that provides five different levels (from "Grade 1 - no bleeding" to "Grade 5")
Measured: 12 months
Surgeon satisfaction At the end of the surgery will be evaluated by one surgeon and recorded according to a 5-point Likert scale (5: excellent, 4: Good, 3: Satisfactory, 2: Poor, 1: Very poor)
Measured: 12 months
Total anesthetic consumption including both inhalational anesthetic consumption and narcotics consumption.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start27 Nov 2024
- Primary completionOct 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypotensive AnesthesiaStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06752863
- Sponsor's protocol ID
- FMASU MD105/2024
- Status last verified
- Jun 2024
- First submitted
- 21 Dec 2024
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Labetalol Infusion Versus Dexmedetomidine Infusion in Hypotensive Anesthesia in Ear, Nose and Throat Surgeries
- ClinicalTrials.gov ID
- NCT06752863
- Acronym / sponsor ID
- FMASU MD105/2024
- Keywords
- Hypotensive anesthesia, Labetalol, Dexmedetomidine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 27 Nov 2024 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 31 Dec 2024 (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.
this study aims to compare between the role of Labetalol infusion versus Dexmedetomidine infusion in hypotensive anesthesia in Ear, Nose and Throat surgeries.
Detailed description
Hypotensive anaesthesia is the deliberate lowering of a patient's blood pressure during surgery. It is necessary during ear, nose and throat surgery for drying surgical field, ease in operation procedure and shortening of the duration of surgery. Labetalol is a unique parenteral anti-hypertensive drug that has selective α1 and non- selective β adrenergic antagonist effects. In humans, the β to α blocking potency ratio is 7: 1 for IV labetalol. Dexmedetomidine is highly selective alpha2 adrenergic agonist having several beneficial actions during the perioperative period. Activation of alpha2 adrenergic receptors in the brain and spinal cord inhibits neuronal firing causing hypotension and bradycardia. This study was designed to compare between the role of Labetalol infusion versus Dexmedetomidine infusion in hypotensive anesthesia in Ear, Nose and Throat surgeries.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing ear, nose and throat surgeries who will receive dexmedetomidine infusion | Active comparator | Drug: Hypotensive anesthesia in ear, nose and throat surgeries using labetalol and dexmedetomidine infusionsDexmedetomidine group: the patients will receive deliberate hypotensive anesthesia with dexmedetomidine infusion (precedex ® 200 μg/2 ml; Hospira, Inc., Rocky Mount, USA) via syringe pump by adding 200 mcg (2ml) of dexmedetomidine to 48 ml of normal saline (final concentration of 4 mcg/ml) The patients will receive a loading dose of 1mcg/kg intravenously followed by an infusion of 0.7 mcg/kg/hour as maintenance dose. |
| Patients undergoing ear, nose and throat surgeries who will receive Labetalol infusion | Active comparator | Drug: Hypotensive anesthesia in ear, nose and throat surgeries using labetalol and dexmedetomidine infusionsLabetalol groups: the patients will receive deliberate hypotensive anesthesia with labetalol infusion (Labipress 100mg/20ml; Al Debeiky pharma(DBK) pharmaceutical co., Cairo, Egypt) via syringe pump by adding 100 mg (20ml) of Labetalol to 30ml of normal saline (final concentration of 2 mg/ml) The patients will receive a loading dose of 0.4mg/kg intravenously followed by an infusion of 0.04mg/kg/hour as maintenance dose. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists I, II (ASA I, II) patients who were candidate for Ear, Nose and Throat surgeries.
- Age: between 20 and 50 years
Key exclusion criteria (5 listed)
- Patients with uncontrolled hypertension, variable degrees of heart block, congestive cardiac failure, coagulopathy, cerebral insufficiency, hepatic or renal abnormality
- Patients on beta blocker or clonidine
- Pregnant or lactating females
- Patients who were allergic to any of the anesthetic or hypotensive drugs used in the study
- Patient refusal to be included in the trial
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 |
|---|---|---|
| Hypotensive anesthesia in ear, nose and throat surgeries using labetalol and dexmedetomidine infusionsThe study compares the role of Labetalol infusion versus Dexmedetomidine infusion in hypotensive anesthesia in patients having ear, nose and throat surgeries | Drug | Patients undergoing ear, nose and throat surgeries who will receive Labetalol infusion, Patients undergoing ear, nose and throat surgeries who will receive dexmedetomidine infusion |
Primary outcome
Mean arterial blood pressure changes before induction of anesthesia & every 15 min throughout deliberate hypotension
Time frame: 12 months
4 secondary outcomes
Heart rate changes before induction of anesthesia and every 15 min
Time frame: 12 months
Surgical site oligaemia will be evaluated by the surgeons by rating the amount of bleeding according to Modena bleeding score that provides five different levels (from "Grade 1 - no bleeding" to "Grade 5")
Time frame: 12 months
Surgeon satisfaction At the end of the surgery will be evaluated by one surgeon and recorded according to a 5-point Likert scale (5: excellent, 4: Good, 3: Satisfactory, 2: Poor, 1: Very poor)
Time frame: 12 months
Total anesthetic consumption including both inhalational anesthetic consumption and narcotics consumption.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
- Individual participant dataSharing planned: Undecided
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Effect of the Superficial Cervical Plexus Block in the Hypotensive Anesthesia of Ear Surgery.
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Dexmedetomidine Versus Dexmedetomidine and Ketamine (Ketodex) in Ear and Nose Surgeries
Ear and Nose Surgeries With Hypotensive Anaesthesia e.g FESS , MLS , TURBINECTOMY
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AKI Risk Factors Analysis After Intentional Hypotensive Anesthesia
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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.
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 Hypotensive anesthesia in ear, nose and throat surgeries using labetalol and dexmedetomidine infusions in people with Hypotensive Anesthesia and Ear, Nose and Throat Procedure, 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 2 inclusion and 5 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 31 Dec 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nourhan Osama, Master degree (002 01064764758, NourhanosamaMohamed@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean arterial blood pressure changes before induction of anesthesia & every 15 min throughout deliberate hypotension (time frame: 12 months). 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 31 Dec 2024.