The Efficacy of Dexmedetomidine Versus Labetalol In Providing Controlled Hypotension In Dacryocystorhinostomy SurgeryA Comparative Randomized Prospective Study

NCT ID: NCT06346561

Last Updated: 2024-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-30

Study Completion Date

2024-08-30

Brief Summary

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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.

Detailed Description

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Conditions

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Nasolacrimal Duct Obstruction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dexmedetomidine group

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

the reduction of controlled hypotension and the control of hemodynamic responses of the body

Labetalol

Intervention Type DRUG

the reduction of controlled hypotension and the control of hemodynamic responses of the body

Labetalol group

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

the reduction of controlled hypotension and the control of hemodynamic responses of the body

Labetalol

Intervention Type DRUG

the reduction of controlled hypotension and the control of hemodynamic responses of the body

Interventions

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Dexmedetomidine

the reduction of controlled hypotension and the control of hemodynamic responses of the body

Intervention Type DRUG

Labetalol

the reduction of controlled hypotension and the control of hemodynamic responses of the body

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* physical status I or II according to ASA classification, age between ( 18 - 60 years )

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Aboesoud Mahmoud

Resident of Anesthesia, Intensive Care and Pain management Sohag university hospital.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sohag University hospitals

Sohag, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mohammad A Mahmoud, Resident

Role: CONTACT

01090684862

Elhadad A Mousa, Professor

Role: CONTACT

01019816967

Facility Contacts

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Magdy M Amin, Professor

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 32703027 (View on PubMed)

Heindl 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.

Reference Type BACKGROUND
PMID: 20958177 (View on PubMed)

Degoute 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.

Reference Type BACKGROUND
PMID: 7875138 (View on PubMed)

Alicandri-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.

Reference Type BACKGROUND
PMID: 33279423 (View on PubMed)

Rahimzadeh 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.

Reference Type BACKGROUND
PMID: 24904785 (View on PubMed)

Other Identifiers

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Soh-Med-24-02-10MS

Identifier Type: -

Identifier Source: org_study_id

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