Nasal Desmopressin Versus Topical Epinephrine in Endonasal Dacryocystorhinostomy
NCT ID: NCT05507476
Last Updated: 2024-10-01
Study Results
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Basic Information
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COMPLETED
NA
52 participants
INTERVENTIONAL
2022-09-01
2023-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Desmopressin group
The patient will receive two puffs of desmopressin acetate 10 µg/puff in the side of the nasal cavity ipsilateral to the obstructed lacrimal duct (20 μg totally) 60 minutes before surgery "Minirin 10 μg/0.1 ml per spray, Ferring Pharmaceutical Company". Three normal saline-soaked packs will be placed in the middle meatus for 5 minutes immediately before the start of surgery.
Desmopressin Acetate Nasal, 10 μg/0.1 ml per spray
The patient will receive two puffs of desmopressin acetate 10 µg/puff in the side of the nasal cavity ipsilateral to the obstructed lacrimal duct (20 μg totally) 60 minutes before surgery.
Epinephrine group
The patient will receive topical 1:100,000 epinephrine in the side of the nasal cavity ipsilateral to the obstructed lacrimal duct via 3 soaked packs placed in the middle meatus for 5 minutes immediately before the start of surgery. The patient will also receive two puffs of normal saline "prepared in emptied Minirin bottle" in the same nasal cavity 60 minutes before surgery.
Epinephrine topical 1:100,000 Nasal Packs
The patient will receive topical 1:100,000 epinephrine in the side of the nasal cavity ipsilateral to the obstructed lacrimal gland via 3 soaked packs placed in the middle meatus for 5 minutes immediately before the start of surgery.
Interventions
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Desmopressin Acetate Nasal, 10 μg/0.1 ml per spray
The patient will receive two puffs of desmopressin acetate 10 µg/puff in the side of the nasal cavity ipsilateral to the obstructed lacrimal duct (20 μg totally) 60 minutes before surgery.
Epinephrine topical 1:100,000 Nasal Packs
The patient will receive topical 1:100,000 epinephrine in the side of the nasal cavity ipsilateral to the obstructed lacrimal gland via 3 soaked packs placed in the middle meatus for 5 minutes immediately before the start of surgery.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Physical status: ASA I \& II.
* Type of operations: elective endonasal dacryocystorhinostomy under general anesthesia.
* Written informed consent from the patient.
Exclusion Criteria
* Known hypersensitivity to study drugs.
* Nasal pathology as active infection or an anatomical abnormality.
* Hyponatremia "serum Na+ less than 135".
* Coagulation disorders.
* Renal or cardiovascular disorders.
18 Years
45 Years
ALL
No
Sponsors
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Zagazig University
OTHER_GOV
Responsible Party
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Principal Investigators
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Alshaimaa Abdel Fattah Kamel, MD
Role: PRINCIPAL_INVESTIGATOR
Assistant professor of Anesthesia, Intensive Care & Pain management,Zagazig University
Marwa Ahmed Mohamed Khedr, MD
Role: PRINCIPAL_INVESTIGATOR
Lecturer of Ophthalmology, Zagazig University
Locations
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Zagazig university hospital
Zagazig, Al-Sharkia, Egypt
Countries
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References
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Vinciguerra A, Nonis A, Giordano Resti A, Ali MJ, Bussi M, Trimarchi M. Role of anaesthesia in endoscopic and external dacryocystorhinostomy: A meta-analysis of 3282 cases. Eur J Ophthalmol. 2022 Jan;32(1):66-74. doi: 10.1177/11206721211035616. Epub 2021 Jul 28.
Shao H, Kuang LT, Hou WJ, Zhang T. Effect of desmopressin administration on intraoperative blood loss and quality of the surgical field during functional endoscopic sinus surgery: a randomized, clinical trial. BMC Anesthesiol. 2015 Apr 17;15:53. doi: 10.1186/s12871-015-0034-8.
Jahanshahi J, Tayebi E, Hashemian F, Bakhshaei MH, Ahmadi MS, Seif Rabiei MA. Effect of local desmopressin administration on intraoperative blood loss and quality of the surgical field during functional endoscopic sinus surgery in patients with chronic rhinosinusitis: a triple-blinded clinical trial. Eur Arch Otorhinolaryngol. 2019 Jul;276(7):1995-1999. doi: 10.1007/s00405-019-05435-3. Epub 2019 Jun 3.
Gruber RP, Zeidler KR, Berkowitz RL. Desmopressin as a hemostatic agent to provide a dry intraoperative field in rhinoplasty. Plast Reconstr Surg. 2015 May;135(5):1337-1340. doi: 10.1097/PRS.0000000000001158.
Korkmaz H, Yao WC, Korkmaz M, Bleier BS. Safety and efficacy of concentrated topical epinephrine use in endoscopic endonasal surgery. Int Forum Allergy Rhinol. 2015 Dec;5(12):1118-23. doi: 10.1002/alr.21590. Epub 2015 Jul 8.
Boezaart AP, van der Merwe J, Coetzee A. Comparison of sodium nitroprusside- and esmolol-induced controlled hypotension for functional endoscopic sinus surgery. Can J Anaesth. 1995 May;42(5 Pt 1):373-6. doi: 10.1007/BF03015479.
Other Identifiers
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Nasal Desmopressin in DCR
Identifier Type: -
Identifier Source: org_study_id
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