Nasal Desmopressin Versus Topical Epinephrine in Endonasal Dacryocystorhinostomy

NCT ID: NCT05507476

Last Updated: 2024-10-01

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

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2023-06-01

Brief Summary

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Dacryocystorhinostomy aims to create a channel between the lacrimal sac and nasal mucosa to relieve nasolacrimal duct occlusion. General anesthesia is still preferred by many surgeons to secure the airway and control blood pressure.

Detailed Description

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Bleeding even minor can obscure the surgical field. This can extend the operative time \& increase the failure rate. The hemostatic effect of desmopressin on the quality of the surgical field was investigated in patients undergoing endoscopic sinus surgery and revealed that desmopressin could reduce intraoperative bleeding.

Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Group Type ACTIVE_COMPARATOR

Desmopressin Acetate Nasal, 10 μg/0.1 ml per spray

Intervention Type DRUG

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.

Group Type ACTIVE_COMPARATOR

Epinephrine topical 1:100,000 Nasal Packs

Intervention Type DRUG

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.

Intervention Type DRUG

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.

Intervention Type DRUG

Other Intervention Names

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Minirin 10 μg/0.1 ml per spray Adrenaline 1 mg / 1ml

Eligibility Criteria

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Inclusion Criteria

* Age: 18-45 years old.
* Physical status: ASA I \& II.
* Type of operations: elective endonasal dacryocystorhinostomy under general anesthesia.
* Written informed consent from the patient.

Exclusion Criteria

* Patient refusal.
* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zagazig University

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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Egypt

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.

Reference Type BACKGROUND
PMID: 34318721 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25895497 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31161361 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25919247 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26152362 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7614641 (View on PubMed)

Other Identifiers

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Nasal Desmopressin in DCR

Identifier Type: -

Identifier Source: org_study_id

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