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

Nasolacrimal Duct Obstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06346561
• Other study ID #: Soh-Med-24-02-10MS
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Hypotension
• Lacrimal Duct Obstruction
• Nasolacrimal Duct Obstruction

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