Chronic SinusitisNCT07855315
FESS With or Without Intranasal Desmopressin in Chronic Rhinosinusitis With Nasal Polyps
A study testing Desmopressin Acetate Nasal, 10 μg/0.1 ml per spray and Functional Endoscopic Sinus Surgery in people with Chronic Sinusitis and Nasal Polyposis, run by Services Institute of Medical Sciences, Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Sinusitis, Nasal Polyposis
- What is being tested?
- Desmopressin Acetate Nasal, 10 μg/0.1 ml per spray and Functional Endoscopic Sinus Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2026to 14 Oct 2027
- Phase
- Interventional
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of Outcomes in Functional Endoscopic Sinus Surgery(FESS) With or Without Preoperative Intranasal Desmopressin in Patients of Chronic Rhinusinusitis With Bilateral Nasal Polyposis
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.
Read more
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.
Read the detailed description
Chronic rhinosinusitis with nasal polyposis (CRSwNP) is a chronic inflammatory condition affecting the nose and paranasal sinuses. Patients may experience persistent nasal obstruction, nasal discharge, facial pressure, and reduced or lost sense of smell. Functional Endoscopic Sinus Surgery (FESS) is performed in patients whose symptoms persist despite appropriate medical treatment.
Intraoperative bleeding is an important consideration during FESS because blood can interfere with visualization of the surgical field and make identification of anatomical structures and surgical dissection more difficult. The study is designed to investigate whether preoperative intranasal desmopressin may influence operative conditions during FESS.
This is a randomized controlled trial to be conducted in the Department of Otorhinolaryngology at Services Hospital, Lahore. Eligible patients with chronic rhinosinusitis with bilateral nasal polyps who are scheduled for elective FESS will be considered for participation. Patients will be randomly allocated into two groups using a computer-generated randomization sequence, with allocation concealment through sequentially numbered opaque sealed envelopes.
Participants assigned to the intervention group will receive 20 μg of intranasal desmopressin, administered as 10 μg in each nostril approximately 30-60 minutes before induction of anesthesia. Participants in the control group will undergo FESS without preoperative intranasal desmopressin. General anesthesia and standardized endoscopic surgical techniques will be used for the procedures.
The study will evaluate intraoperative blood loss and the quality of the surgical field. Blood loss will be estimated using the suction canister volume after accounting for irrigation fluid, together with estimation of blood absorbed by surgical patties and nasal packs. Surgical-field quality will be assessed using the Boezaart Surgical Field Grading Scale. Additional outcomes include operative duration, surgeon satisfaction, nasal packing requirement, postoperative bleeding, and perioperative complications.
The study population will consist of adults aged 18-60 years with chronic rhinosinusitis with bilateral nasal polyps who are planned for elective FESS and meet the specified eligibility criteria. Patients with conditions such as known bleeding disorders, use of anticoagulant or antiplatelet medication, hyponatremia or previous hyponatremia, uncontrolled hypertension, significant cardiovascular disease, fungal rhinosinusitis with polyps, or previous revision FESS will be excluded according to the study protocol.
The collected data will be analyzed using SPSS version 26.0. Continuous and categorical outcomes will be analyzed using statistical tests appropriate to their distribution and measurement characteristics. The study will use a two-sided significance level of p ≤ 0.05.
The study is intended to determine whether the addition of preoperative intranasal desmopressin is associated with differences in operative conditions during FESS for CRSwNP. The findings will provide evidence regarding intraoperative blood loss, surgical-field quality, operative duration, and other perioperative outcomes in the study population.
- Conditions
- Chronic Sinusitis, Nasal Polyposis
- Being tested
- Desmopressin Acetate Nasal, 10 μg/0.1 ml per spray, Functional Endoscopic Sinus Surgery
- Keywords
- Chronic Sinusitis, Functional Endoscopic Sinus surgery(FESS), Boezart Bleeding Score, Nasal Polyposis, Intranasal desmopressin
- Medical subject headings
- Nasal Polyps
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
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).
Functional Endoscopic Sinus SurgeryProcedure or surgery
Participants will undergo Functional Endoscopic Sinus Surgery (FESS) without preoperative intranasal desmopressin.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Procedure: Functional Endoscopic Sinus Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During surgery (intraoperative period)
Secondary outcomes (1)
Quality of Surgical Field During FESS
Quality of the surgical field will be assessed using the Boezaart Surgical Field Grading Scale, ranging from Grade 0 (no bleeding) to Grade 5 (severe bleeding requiring constant suctioning and preventing surgical dissection).
Measured: During surgery (intraoperative period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start15 Oct 2026 (estimated)
- Primary completion14 Oct 2027 (estimated)
- Study completion14 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic SinusitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Services Institute of Medical Sciences, Pakistan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Daniyal Babar, Services Institute of Medical Sciences, Pakistan
- Investigators
- Daniyal Babar, Principal investigator, Services Institute of Medical Sciences, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07855315
- Sponsor's protocol ID
- IRB/2026/1813/SIMS
- Status last verified
- Oct 2026
- First submitted
- 27 Sep 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers. Study data will be used by the research team for the purposes of this study and will be maintained confidentially in accordance with applicable ethical and institutional requirements.
Publications
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