FESS With or Without Intranasal Desmopressin in Chronic Rhinosinusitis With Nasal Polyps

NCT07855315 | Not Yet Recruiting

• 1 other identifier: IRB/2026/1813/SIMS
• Study Type: interventional
• Target: 174
• Locations: 0 countries
• Sites: N/A

Brief Summary

Chronic rhinosinusitis with nasal polyps is a condition that causes long-lasting inflammation and swelling in the nose and sinuses and may lead to nasal blockage, nasal discharge, facial pressure, and reduced sense of smell. Functional Endoscopic Sinus Surgery (FESS) is a surgical treatment used when medical treatment has not adequately controlled the condition. Bleeding during FESS can make it difficult for the surgeon to see and operate safely. This randomized controlled trial will compare FESS performed with and without preoperative intranasal desmopressin in patients with chronic rhinosinusitis with nasal polyps. Patients will be randomly assigned to one of two groups. The intervention group will receive 20 micrograms of intranasal desmopressin 30-60 minutes before surgery, while the control group will undergo FESS without preoperative desmopressin. The study will assess intraoperative blood loss, quality of the surgical field, operative time, surgeon satisfaction, and perioperative complications. The study will include patients undergoing elective FESS at the Department of Otorhinolaryngology, Services Hospital, Lahore. The purpose of this study is to determine whether preoperative intranasal desmopressin can reduce bleeding and improve the surgical field during FESS. The findings may provide local evidence to help inform perioperative management of patients undergoing FESS for chronic rhinosinusitis with nasal polyps.

Conditions

Chronic Rhinosinusitis (CRS) With Nasal Polyposis

Keywords

Chronic Rhinosinusitis With Nasal Polyposis; Functional Endoscopic Sinus Surgery; FESS; Intranasal Desmopressin; Intraoperative Blood Loss; Surgical Field

Outcome Measures

Primary Outcomes (1)

• Intraoperative Blood Loss During Functional Endoscopic Sinus Surgery

  Total intraoperative blood loss during FESS, measured in milliliters (mL). Blood loss will be calculated from the volume collected in the suction canister after subtracting the volume of irrigation fluid used during surgery and adding the estimated blood volume absorbed by blood-soaked nasal patties and surgical packs.

  During surgery (intraoperative period)

Secondary Outcomes (1)

• Quality of Surgical Field During FESS

  During surgery (intraoperative period)

Study Arms (2)

Intervention

EXPERIMENTAL

Participants will receive intranasal desmopressin 20 μg (10 μg in each nostril) 30-60 minutes before induction of anesthesia, followed by Functional Endoscopic Sinus Surgery (FESS).

Drug: Desmopressin Acetate Nasal, 10 μg/0.1 ml per spray

Control

ACTIVE COMPARATOR

Participants will undergo Functional Endoscopic Sinus Surgery (FESS) without preoperative intranasal desmopressin.

Procedure: Functional Endoscopic Sinus Surgery

Interventions

Desmopressin Acetate Nasal, 10 μg/0.1 ml per spray DRUG

Intranasal desmopressin 20 μg (10 μg in each nostril) will be administered 30-60 minutes before induction of anesthesia in participants undergoing Functional Endoscopic Sinus Surgery (FESS).

Intervention

Functional Endoscopic Sinus Surgery PROCEDURE

Participants will undergo Functional Endoscopic Sinus Surgery (FESS) without preoperative intranasal desmopressin.

Control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aged 18-60 years.
• Diagnosed cases of chronic rhinosinusitis with bilateral nasal polyps.
• Patients planned for elective Functional Endoscopic Sinus Surgery (FESS).
• Patients with ASA physical status I or II.

You may not qualify if:

• Known bleeding disorders.
• Fungal rhinosinusitis with polyps.
• Use of anticoagulant or antiplatelet drugs.
• Hyponatremia or history of hyponatremia.
• Ischemic heart disease or uncontrolled hypertension.
• Revision FESS.

Sponsors & Collaborators

• Services Institute of Medical Sciences, Pakistan: lead

Related Publications (1)

• 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.

  PMID: 31161361 BACKGROUND

Study Officials

• Daniyal Babar

  Services Institute of Medical Sciences, Pakistan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniyal Babar, MS(ENT)

CONTACT

+923114214929; daniyallhr99@gmail.com

Noman Ali, MS(ENT)

CONTACT

+923053399793; nomi.mbbs@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No additional parties are masked in this study. The study is open-label.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Daniyal Babar

Model Details: Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups. The intervention group will receive preoperative intranasal desmopressin 20 μg (10 μg in each nostril) 30-60 minutes before induction of anesthesia, followed by Functional Endoscopic Sinus Surgery (FESS). The control group will undergo FESS without preoperative intranasal desmopressin. Both groups will receive standardized general anesthesia and endoscopic surgical management. Outcomes will be compared between the two groups.

Study Record Dates

• First Submitted: September 27, 2026
• First Posted: October 2, 2026
• Study Start (Estimated): October 15, 2026
• Primary Completion (Estimated): October 14, 2027
• Study Completion (Estimated): October 14, 2027
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share