Nasal Desmopressin Versus Topical Epinephrine in Endonasal Dacryocystorhinostomy

Anesthesia Clinical Trial

Official title:

Effects of Nasal Desmopressin Spray Versus Topical Epinephrine on Surgical Field Clarity and Hemodynamics in Endonasal Dacryocystorhinostomy: A Randomized Clinical Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05507476
• Other study ID #: Nasal Desmopressin in DCR
• Status: Completed
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: June 1, 2023

Study information

• Verified date: June 2023
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Egypt	Zagazig university hospital	Zagazig	Al-Sharkia

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	The Surgical field clarity	The quality of surgical field based on BOEZAART grading system(0 no bleeding; 1 slight bleeding: no suctioning is needed; 2 slight bleeding: occasional suctioning needed;, 3 sight bleeding: frequent suctioning required, bleeding threatens surgical field a few seconds after suction is removed; 4 moderate bleeding: frequent suctioning required and bleeding threatens surgical field directly after suction is removed; 5 severe bleeding: constant suctioning required)	at the end of surgery
Secondary	Change in heart rate (HR) in beat per minute	Change in heart rate (HR) from baseline.	will be recorded at 2 minutes, 5 minutes, 10 minutes, 30 minutes and 60 minutes after topical epinephrine packs insertion.
Secondary	Change mean arterial blood pressure (MAP) in mmHg	Change mean arterial blood pressure (MAP) from baseline.	will be recorded at 2 minutes, 5 minutes, 10 minutes, 30 minutes and 60 minutes after topical epinephrine packs insertion.
Secondary	Change oxygen saturation (SPO2)	Change oxygen saturation (SPO2) from baseline.	will be recorded at 2 minutes, 5 minutes, 10 minutes, 30 minutes and 60 minutes after topical epinephrine packs insertion.
Secondary	Change in serum sodium level	Serum sodium level will be measured pre & postoperative to detect and manage any sodium disturbances.	preoperative and after 12 hours postoperative
Secondary	The surgeon's satisfaction	The surgeon was asked to rate satisfaction at the end of surgery (4 =excellent, 3 = good, 2 = fair, 1 = poor, 0 = extremely poor).	At the end of surgery