Clinical trial NCT05507476: Nasal Desmopressin Versus Topical Epinephrine in Endonasal Dacryocystorhinostomy
Official title: Effects of Nasal Desmopressin Spray Versus Topical Epinephrine on Surgical Field Clarity and Hemodynamics in Endonasal Dacryocystorhinostomy: a Randomized Clinical Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Keywords: Desmopressin
Dacryocystorhinostomy
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2022-08-19
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Intraoperative blood loss
timeFrame: Measurement will be done at the 30th minutes of the start of surgery.
measure: Intraoperative blood loss
timeFrame: Measurement will be done at 60th minutes of the start of surgery.
Secondary outcomes:
measure: The Surgical field clarity
timeFrame: at the end of surgery
measure: Change in heart rate (HR) in beat per minute
timeFrame: will be recorded at 2 minutes, 5 minutes, 10 minutes, 30 minutes and 60 minutes after topical epinephrine packs insertion.
measure: Change mean arterial blood pressure (MAP) in mmHg
timeFrame: will be recorded at 2 minutes, 5 minutes, 10 minutes, 30 minutes and 60 minutes after topical epinephrine packs insertion.
measure: Change oxygen saturation (SPO2)
timeFrame: will be recorded at 2 minutes, 5 minutes, 10 minutes, 30 minutes and 60 minutes after topical epinephrine packs insertion.
measure: Change in serum sodium level
timeFrame: preoperative and after 12 hours postoperative
measure: The surgeon's satisfaction
timeFrame: At the end of surgery
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig university hospital
state: Al-Sharkia
Study officials:
affiliation: Assistant professor of Anesthesia, Intensive Care & Pain management,Zagazig University
name: Alshaimaa Abdel Fattah Kamel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lecturer of Ophthalmology, Zagazig University
name: Marwa Ahmed Mohamed Khedr, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
citation: 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.