Nasal Desmopressin Versus Topical Epinephrine in Endonasal Dacryocystorhinostomy

September 26, 2024 updated by: Zagazig University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Al-Sharkia
      • Zagazig, Al-Sharkia, Egypt, 44519
        • Zagazig university hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Desmopressin group
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 "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.
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.
Other Names:
  • Minirin 10 μg/0.1 ml per spray
Active Comparator: Epinephrine group
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.
Drug: 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.
Other Names:
  • Adrenaline 1 mg / 1ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
at the end of surgery
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.
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) 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.
will be recorded at 2 minutes, 5 minutes, 10 minutes, 30 minutes and 60 minutes after topical epinephrine packs insertion.
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.
will be recorded at 2 minutes, 5 minutes, 10 minutes, 30 minutes and 60 minutes after topical epinephrine packs insertion.
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.
preoperative and after 12 hours postoperative
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).
At the end of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zagazig University

Investigators

  • Principal Investigator: Alshaimaa Abdel Fattah Kamel, MD, Assistant professor of Anesthesia, Intensive Care & Pain management,Zagazig University
  • Principal Investigator: Marwa Ahmed Mohamed Khedr, MD, Lecturer of Ophthalmology, Zagazig University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Actual)

June 1, 2023

Study Completion (Actual)

June 1, 2023

Study Registration Dates

First Submitted

August 14, 2022

First Submitted That Met QC Criteria

August 16, 2022

First Posted (Actual)

August 19, 2022

Study Record Updates

Last Update Posted (Actual)

October 1, 2024

Last Update Submitted That Met QC Criteria

September 26, 2024

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Nasal Desmopressin in DCR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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