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

NCT06346561 | Recruiting

• 1 other identifier: Soh-Med-24-02-10MS
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nasolacrimal Duct Obstruction

Outcome Measures

Primary Outcomes (1)

• 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

  5 months

Secondary Outcomes (1)

• Effectiveness of dexamedetomidine for prolongation of postoperative analgesia.

  5 months

Study Arms (2)

Dexmedetomidine group

ACTIVE COMPARATOR

Drug: Dexmedetomidine; Drug: Labetalol

Labetalol group

ACTIVE COMPARATOR

Drug: Dexmedetomidine; Drug: Labetalol

Interventions

Dexmedetomidine DRUG

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

Dexmedetomidine group; Labetalol group

Labetalol DRUG

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

Dexmedetomidine group; Labetalol group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University hospitals

Sohag, Egypt

RECRUITING

Related Publications (5)

• 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.

  PMID: 32703027 BACKGROUND

• 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.

  PMID: 20958177 BACKGROUND

• 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.

  PMID: 7875138 BACKGROUND

• 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.

  PMID: 33279423 BACKGROUND

• 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.

  PMID: 24904785 BACKGROUND

MeSH Terms

Conditions

Lacrimal Duct Obstruction

Interventions

Dexmedetomidine; Labetalol

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Salicylamides; Amides; Amines

Central Study Contacts

Mohammad A Mahmoud, Resident

CONTACT

01090684862; mohamedaboelsoad@med.sohag.edu.eg

Elhadad A Mousa, Professor

CONTACT

01019816967

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Anesthesia, Intensive Care and Pain management Sohag university hospital.

Study Record Dates

• First Submitted: March 10, 2024
• First Posted: April 4, 2024
• Study Start: March 30, 2024
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2024
• Last Updated: April 4, 2024

Record last verified: 2024-03

Locations

EG (1)