Nasal Desmopressin Versus Topical Epinephrine in Endonasal Dacryocystorhinostomy

NCT05507476 | Completed

• 1 other identifier: Nasal Desmopressin in DCR
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anesthesia

Keywords

Desmopressin; Dacryocystorhinostomy

Outcome Measures

Primary Outcomes (2)

• Intraoperative blood loss

  Estimation of intraoperative blood loss will be done at 30th minutes of surgery. by calculating the loss of blood and irrigation saline in 50 mL-graded suction canisters.

  Measurement will be done at the 30th minutes of the start of surgery.

• Intraoperative blood loss

  Estimation of intraoperative blood loss will be done at 60th minutes of surgery. by calculating the loss of blood and irrigation saline in 50 mL-graded suction canisters.

  Measurement will be done at 60th minutes of the start of surgery.

Secondary Outcomes (6)

• The Surgical field clarity

  at the end of surgery

• Change in heart rate (HR) in beat per minute

  will be recorded at 2 minutes, 5 minutes, 10 minutes, 30 minutes and 60 minutes after topical epinephrine packs insertion.

• Change mean arterial blood pressure (MAP) in mmHg

  will be recorded at 2 minutes, 5 minutes, 10 minutes, 30 minutes and 60 minutes after topical epinephrine packs insertion.

• Change oxygen saturation (SPO2)

  will be recorded at 2 minutes, 5 minutes, 10 minutes, 30 minutes and 60 minutes after topical epinephrine packs insertion.

• Change in serum sodium level

  preoperative and after 12 hours postoperative

Study Arms (2)

Desmopressin group

ACTIVE COMPARATOR

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.

Drug: Desmopressin Acetate Nasal, 10 μg/0.1 ml per spray

Epinephrine group

ACTIVE COMPARATOR

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.

Drug: Epinephrine topical 1:100,000 Nasal Packs

Interventions

Desmopressin Acetate Nasal, 10 μg/0.1 ml per spray 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.

Also known as: Minirin 10 μg/0.1 ml per spray

Desmopressin group

Epinephrine topical 1:100,000 Nasal Packs 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.

Also known as: Adrenaline 1 mg / 1ml

Epinephrine group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig university hospital

Zagazig, Al-Sharkia, 44519, Egypt

Location

Related Publications (6)

• 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.

  PMID: 34318721 BACKGROUND

• 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.

  PMID: 25895497 BACKGROUND

• 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.

  PMID: 31161361 BACKGROUND

• 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.

  PMID: 25919247 BACKGROUND

• 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.

  PMID: 26152362 BACKGROUND

• 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.

  PMID: 7614641 BACKGROUND

MeSH Terms

Interventions

Deamino Arginine Vasopressin; Epinephrine

Intervention Hierarchy (Ancestors)

Arginine Vasopressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Alshaimaa Abdel Fattah Kamel, MD

  Assistant professor of Anesthesia, Intensive Care & Pain management,Zagazig University

  PRINCIPAL INVESTIGATOR

• Marwa Ahmed Mohamed Khedr, MD

  Lecturer of Ophthalmology, Zagazig University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2022
• First Posted: August 19, 2022
• Study Start: September 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: October 1, 2024

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)