Nasal Desmopressin Versus Topical Epinephrine in Endonasal Dacryocystorhinostomy

What Was Tested

The trial (not phased) is built around Desmopressin.

Dacryocystorhinostomy aims to create a channel between the lacrimal sac and nasal mucosa to relieve nasolacrimal duct occlusion.

It had two arms (groups): Desmopressin group (active comparator) and 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.

The registry classes the interventions as drug.

Who Took Part

The registry lists 52 actual participants took part.

It was open to people of any sex aged from 18 years up to 45 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could 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.

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: patient refusal; known hypersensitivity to study drugs; nasal pathology as active infection or an anatomical abnormality.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

Random assignment meant chance, not the researchers, decided who got Desmopressin and who got the comparison, which limits bias.

The Desmopressin group and the comparison group ran side by side rather than switching.

As a double-blind Desmopressin study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and outcomes assessor.

It started in 2022-09-01 with completion listed for 2023-06-01.

It ran at 1 site in Egypt.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: Intraoperative blood loss (time frame: Measurement will be done at the 30th minutes of the start of surgery). Intraoperative blood loss (time frame: Measurement will be done at 60th minutes of the start of surgery).

It also tracked 6 secondary outcomes, for example The Surgical field clarity, Change in heart rate (HR) in beat per minute, Change mean arterial blood pressure (MAP) in mmHg, Change oxygen saturation (SPO2), Change in serum sodium level and The surgeon's satisfaction.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Desmopressin in 52 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Desmopressin compound page, all human trials.