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Completed

NCT Number: NCT05507476

Nasal Desmopressin Versus Topical Epinephrine in Endonasal Dacryocystorhinostomy

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.

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Key information

Conditions

Anesthesia

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zagazig university hospital

Zagazig, Al-Sharkia, 44519, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Minirin 10 μg/0.1 ml per spray

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.

Other names: Adrenaline 1 mg / 1ml

Primary outcomes

  1. Intraoperative blood loss

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

    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.

  2. Intraoperative blood loss

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

    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.

Secondary outcomes

  1. The Surgical field clarity

    Time frame: at the end of surgery

    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)

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

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

    Change in heart rate (HR) from baseline.

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

    Time frame: 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) from baseline.

  4. Change oxygen saturation (SPO2)

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

    Change oxygen saturation (SPO2) from baseline.

  5. Change in serum sodium level

    Time frame: preoperative and after 12 hours postoperative

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

  6. The surgeon's satisfaction

    Time frame: At the end of surgery

    The surgeon was asked to rate satisfaction at the end of surgery (4 =excellent, 3 = good, 2 = fair, 1 = poor, 0 = extremely poor).

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 19, 2022
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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