Nasolacrimal Duct ObstructionNCT06346561
The Efficacy of Dexmedetomidine Versus Labetalol In Providing Controlled Hypotension In Dacryocystorhinostomy SurgeryA Comparative Randomized Prospective Study
A study testing Dexmedetomidine and Labetalol in people with Nasolacrimal Duct Obstruction, run by Sohag University at 1 site in Egypt.
Trial summary
The most important symptoms of nasolacrimal duct obstruction are excessive tearing and mucoid discharge. The proposed treatment in this regard is dacryocystorhinostomy (DCR) surgery. Therefore, hemostasis is of great significance in performing DCR surgery. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Nasolacrimal Duct Obstruction
- What is being tested?
- Dexmedetomidine and Labetalol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Mar 2024to 30 Aug 2024
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- physical status I or II according to ASA classification, age between ( 18 - 60 years )
Who cannot join
- Patients with physical status other than 1 and 2 according to ASA classification as :Hypertension, Diabetes mellitus, Ischemic heart diseases, Severe anemia, COPD, History of stroke, Impaired liver or renal function, Increase intercranial tension.
- Allergy to any of the drug included in this study.
Trial locations and contacts
1 site in 1 country.
Elhadad A Mousa, Professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag University hospitals
Sohag
Magdy M Amin, Professor
About this study
The most important symptoms of nasolacrimal duct obstruction are excessive tearing and mucoid discharge.
The proposed treatment in this regard is dacryocystorhinostomy (DCR) surgery. Therefore, hemostasis is of great significance in performing DCR surgery. In this regard, the reduction of controlled hypotension and the control of hemodynamic responses of the body to stress effectively reduce the bleeding volume during surgery.
Hence, there is no enough studies about controlled hypotension in DCR we decided to perform such a comparison between the effect of dexmedetomidine and labetalol in providing controlled hypotension during DCR surgery.
- Conditions
- Nasolacrimal Duct Obstruction
- Being tested
- Dexmedetomidine, Labetalol
- Medical subject headings
- Lacrimal Duct Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
the reduction of controlled hypotension and the control of hemodynamic responses of the body
LabetalolDrug
the reduction of controlled hypotension and the control of hemodynamic responses of the body
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine group | Active comparator | Not described Receives: Drug: Dexmedetomidine; Drug: Labetalol |
| Labetalol group | Active comparator | Not described Receives: Drug: Dexmedetomidine; Drug: Labetalol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess non invasive blood pressure during DCR surgery To compare between the effect of dexmedetomidine and labetalol in providing controlled hypotension.
Controlled Hypotension In Dacryocystorhinostomy Surgery By:
Dexmedetomidine is a potent α2 adrenergic agonist. Labetalol is a beta-adrenergic blocker agent with alpha1 and beta-adrenergic receptors blocking action
Measured: 5 months
Secondary outcomes (1)
Effectiveness of dexamedetomidine for prolongation of postoperative analgesia.
Dexmedetomidine is a potent α2 adrenergic agonist. One of the highest densities of α2 receptors is located in the pontine locus cereleus, an important nucleus mediating sympathetic nervous system function. It has sedative, anxiolytic, hypnotic, analgesic, and sympatholytic properties.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start30 Mar 2024 (estimated)
- Primary completion30 Aug 2024 (estimated)
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Nasolacrimal Duct ObstructionStudies of the same condition, open and under way.
- More trials run by Sohag 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Aboesoud Mahmoud, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06346561
- Sponsor's protocol ID
- Soh-Med-24-02-10MS
- Status last verified
- Mar 2024
- First submitted
- 10 Mar 2024
- Last updated
- 4 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Vinciguerra A, Nonis A, Resti AG, Bussi M, Trimarchi M. Impact of Post-Surgical Therapies on Endoscopic and External Dacryocystorhinostomy: Systematic Review and Meta-Analysis. Am J Rhinol Allergy. 2020 Nov;34(6):846-856. doi: 10.1177/1945892420945218. Epub 2020 Jul 23.
PubMed 32703027Heindl LM, Junemann AG, Kruse FE, Holbach LM. Tumors of the lacrimal drainage system. Orbit. 2010 Oct;29(5):298-306. doi: 10.3109/01676830.2010.492887.
PubMed 20958177Degoute CS, Dubreuil C, Ray MJ, Guitton J, Manchon M, Banssillon V, Saumet JL. Effects of posture, hypotension and locally applied vasoconstriction on the middle ear microcirculation in anaesthetized humans. Eur J Appl Physiol Occup Physiol. 1994;69(5):414-20. doi: 10.1007/BF00865405.
PubMed 7875138Alicandri-Ciufelli M, Pingani L, Maccarrone F, Anschuetz L, Mariano D, Galeazzi GM, Presutti L, Molinari G. Validation of the Modena bleeding score in endoscopic sinus surgery. Braz J Otorhinolaryngol. 2022 Jul-Aug;88(4):602-606. doi: 10.1016/j.bjorl.2020.08.006. Epub 2020 Sep 30.
PubMed 33279423Rahimzadeh P, Faiz SH, Alebouyeh MR. Effects of premedication with metoprolol on bleeding and induced hypotension in nasal surgery. Anesth Pain Med. 2012 Winter;1(3):157-61. doi: 10.5812/kowsar.22287523.3408. Epub 2012 Jan 1.
PubMed 24904785
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Dexmedetomidine Versus Labetalol In Providing Controlled Hypotension In Dacryocystorhinostomy SurgeryA Comparative Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT06346561
- Acronym / sponsor ID
- Soh-Med-24-02-10MS
- Conditions
- Nasolacrimal Duct Obstruction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 30 Mar 2024 (estimated)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 4 Apr 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.
The most important symptoms of nasolacrimal duct obstruction are excessive tearing and mucoid discharge.
The proposed treatment in this regard is dacryocystorhinostomy (DCR) surgery. Therefore, hemostasis is of great significance in performing DCR surgery. In this regard, the reduction of controlled hypotension and the control of hemodynamic responses of the body to stress effectively reduce the bleeding volume during surgery.
Hence, there is no enough studies about controlled hypotension in DCR we decided to perform such a comparison between the effect of dexmedetomidine and labetalol in providing controlled hypotension during DCR surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine group | Active comparator | Drug: Dexmedetomidine, Drug: Labetalol |
| Labetalol group | Active comparator | Drug: Dexmedetomidine, Drug: Labetalol |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- physical status I or II according to ASA classification, age between ( 18 - 60 years )
Key exclusion criteria (2 listed)
- Patients with physical status other than 1 and 2 according to ASA classification as :Hypertension, Diabetes mellitus, Ischemic heart diseases, Severe anemia, COPD, History of stroke, Impaired liver or renal function, Increase intercranial tension.
- Allergy to any of the drug included in this 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 |
|---|---|---|
| Dexmedetomidinethe reduction of controlled hypotension and the control of hemodynamic responses of the body | Drug | Dexmedetomidine group, Labetalol group |
| Labetalolthe reduction of controlled hypotension and the control of hemodynamic responses of the body | Drug | Dexmedetomidine group, Labetalol group |
Primary outcome
Assess non invasive blood pressure during DCR surgery To compare between the effect of dexmedetomidine and labetalol in providing controlled hypotension.
Time frame: 5 months
Controlled Hypotension In Dacryocystorhinostomy Surgery By: Dexmedetomidine is a potent α2 adrenergic agonist. Labetalol is a beta-adrenergic blocker agent with alpha1 and beta-adrenergic receptors blocking action
1 secondary outcome
Effectiveness of dexamedetomidine for prolongation of postoperative analgesia.
Time frame: 5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
- Background: PubMed 32703027Vinciguerra A, Nonis A, Resti AG, Bussi M, Trimarchi M. Impact of Post-Surgical Therapies on Endoscopic and External Dacryocystorhinostomy: Systematic Review and Meta-Analysis. Am J Rhinol Allergy. 2020 Nov;34(6):846-856. doi: 10.1177/1945892420945218. Epub 2020 Jul 23.
- Background: PubMed 20958177Heindl LM, Junemann AG, Kruse FE, Holbach LM. Tumors of the lacrimal drainage system. Orbit. 2010 Oct;29(5):298-306. doi: 10.3109/01676830.2010.492887.
- Background: PubMed 7875138Degoute CS, Dubreuil C, Ray MJ, Guitton J, Manchon M, Banssillon V, Saumet JL. Effects of posture, hypotension and locally applied vasoconstriction on the middle ear microcirculation in anaesthetized humans. Eur J Appl Physiol Occup Physiol. 1994;69(5):414-20. doi: 10.1007/BF00865405.
- Background: PubMed 33279423Alicandri-Ciufelli M, Pingani L, Maccarrone F, Anschuetz L, Mariano D, Galeazzi GM, Presutti L, Molinari G. Validation of the Modena bleeding score in endoscopic sinus surgery. Braz J Otorhinolaryngol. 2022 Jul-Aug;88(4):602-606. doi: 10.1016/j.bjorl.2020.08.006. Epub 2020 Sep 30.
- Background: PubMed 24904785Rahimzadeh P, Faiz SH, Alebouyeh MR. Effects of premedication with metoprolol on bleeding and induced hypotension in nasal surgery. Anesth Pain Med. 2012 Winter;1(3):157-61. doi: 10.5812/kowsar.22287523.3408. Epub 2012 Jan 1.
- Individual participant dataSharing planned: Undecided
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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.
Elhadad A Mousa, Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine and Labetalol in people with Nasolacrimal Duct Obstruction, run by Sohag 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 2 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 4 Apr 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.
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 Mohammad A Mahmoud, Resident (01090684862, mohamedaboelsoad@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess non invasive blood pressure during DCR surgery To compare between the effect of dexmedetomidine and labetalol in providing controlled hypotension. (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06346561, which also lists 5 linked publications.
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 4 Apr 2024.