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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06346561
Other study ID # Soh-Med-24-02-10MS
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 30, 2024
Est. completion date August 30, 2024

Study information

Verified date March 2024
Source Sohag University
Contact Mohammad A Mahmoud, Resident
Phone 01090684862
Email mohamedaboelsoad@med.sohag.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date August 30, 2024
Est. primary completion date August 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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.

Study Design


Intervention

Drug:
Dexmedetomidine
the reduction of controlled hypotension and the control of hemodynamic responses of the body
Labetalol
the reduction of controlled hypotension and the control of hemodynamic responses of the body

Locations

Country Name City State
Egypt Sohag University hospitals Sohag

Sponsors (1)

Lead Sponsor Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 a2 adrenergic agonist. Labetalol is a beta-adrenergic blocker agent with alpha1 and beta-adrenergic receptors blocking action
5 months
Secondary Effectiveness of dexamedetomidine for prolongation of postoperative analgesia. Dexmedetomidine is a potent a2 adrenergic agonist. One of the highest densities of a2 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. 5 months
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