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AzTrials

AnesthesiaNCT05507476

Nasal Desmopressin Versus Topical Epinephrine in Endonasal Dacryocystorhinostomy

A study testing Desmopressin Acetate Nasal, 10 μg/0.1 ml per spray and Epinephrine topical 1:100,000 Nasal Packs in people with Anesthesia, run by Zagazig University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 45 years
Conditions the study is for
Anesthesia
What is being tested?
Desmopressin Acetate Nasal, 10 μg/0.1 ml per spray and Epinephrine topical 1:100,000 Nasal Packs
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteEgypt
Study dates
1 Sep 2022to 1 Jun 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Zagazig university hospital

    Zagazig, Al-Sharkia, 44519

Other trials in Egypt

About this study

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

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.

Read the 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.

Conditions
Anesthesia
Being tested
Desmopressin Acetate Nasal, 10 μg/0.1 ml per spray, Epinephrine topical 1:100,000 Nasal Packs
Keywords
Desmopressin, Dacryocystorhinostomy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Desmopressin Acetate Nasal, 10 μg/0.1 ml per sprayDrug

    Also called Minirin 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 PacksDrug

    Also called Adrenaline 1 mg / 1ml

    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.

Study groups in NCT05507476
Study groupRoleWhat they receive
Desmopressin groupActive comparatorThe 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.
Receives: Drug: Desmopressin Acetate Nasal, 10 μg/0.1 ml per spray
Epinephrine groupActive comparatorThe 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.
Receives: Drug: Epinephrine topical 1:100,000 Nasal Packs

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

Secondary outcomes (6)

  1. 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)

    Measured: at the end of surgery

  2. Change in heart rate (HR) in beat per minute

    Change in heart rate (HR) from baseline.

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

  3. Change mean arterial blood pressure (MAP) in mmHg

    Change mean arterial blood pressure (MAP) from baseline.

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

  4. Change oxygen saturation (SPO2)

    Change oxygen saturation (SPO2) from baseline.

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

  5. Change in serum sodium level

    Serum sodium level will be measured pre \& postoperative to detect and manage any sodium disturbances.

    Measured: preoperative and after 12 hours postoperative

  6. 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).

    Measured: At the end of surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2022
  2. Study start1 Sep 2022
  3. Primary completion1 Jun 2023
  4. Study completion1 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05507476
Sponsor's protocol ID
Nasal Desmopressin in DCR
Status last verified
Jun 2023
First submitted
14 Aug 2022
Last updated
1 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 34318721

  • 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.

    PubMed 25895497

  • 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.

    PubMed 31161361

  • 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.

    PubMed 25919247

  • 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.

    PubMed 26152362

  • 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.

    PubMed 7614641

Questions about this trial

What is this clinical trial studying?

A study testing Desmopressin Acetate Nasal, 10 μg/0.1 ml per spray and Epinephrine topical 1:100,000 Nasal Packs in people with Anesthesia, run by Zagazig University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intraoperative blood loss (time frame: Measurement will be done at the 30th minutes of the start of surgery.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05507476, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.

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