| CTRI Number |
CTRI/2026/01/101509 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
17/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study to evaluate the effect of Desmopressin nasal application on bleeding control in sinus surgery. |
|
Scientific Title of Study
|
Effect of topical Desmopressin on bleeding and quality of surgical field during Functional Endoscopic Sinus Surgery. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. V .Srinivasa |
| Designation |
Professor and Head of the Department |
| Affiliation |
Vinayaka Missions University : Vinayaka Missions Research Foundation (Deemed To Be University) |
| Address |
Department of ENT,
Vinayaka Mission Medical College and Hospital,
Keezhakasakudy Medu,Kottucherry P.O
Karaikal.
Karaikal PONDICHERRY 609609 India |
| Phone |
09842774997 |
| Fax |
|
| Email |
vemsrigeenan2@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr ATHULYA S |
| Designation |
POSTGRADUATE |
| Affiliation |
Vinayaka Missions University : Vinayaka Missions Research Foundation (Deemed To Be University) |
| Address |
ENT DEPARTMENT
VINAYAKA MISSIONS MEDICAL COLLEGE AND HOSPITAL
KEEZHAKASAKUDIMEDU
Karaikal PONDICHERRY 609609 India |
| Phone |
9895681355 |
| Fax |
|
| Email |
athummc@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr. Athulya. S |
| Designation |
Postgraduate |
| Affiliation |
Vinayaka Missions University : Vinayaka Missions Research Foundation (Deemed To Be University) |
| Address |
Department of ENT,
Vinayaka Missions Medical College and Hospital,
Keezhakasakudy Medu,Kottucherry P.O
Karaikal.
Karaikal PONDICHERRY 609609 India |
| Phone |
9895681355 |
| Fax |
|
| Email |
athummc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka Mission Research Foundation student research grant , Vinayaka Missions Medical College and Hospital ,Keezhakasakudy Medu ,Kottucherry P.O ,Karaikal ,609609, Puducherry,India
|
|
|
Primary Sponsor
|
| Name |
Vinayaka missions research foundation |
| Address |
Vinayaka missions medical college and hospital,keezhakasakudimedu, karaiakl , 609609 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr AthulyaS |
Vinayaka Missions Medical College and Hospital, Karaikal |
ICU block ,Room Number 10,
Department Of ENT Karaikal PONDICHERRY |
9895681355
athummc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vinayaka Missions Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J329||Chronic sinusitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Functional Endoscopic Sinus Surgery. |
Conventional FESS without the use of Desmopressin nasal spray. |
| Intervention |
Use of Desmopressin nasal spray prior to surgery (Functional endoscopic sinus surgery) in Chronic Rhinosinusitis patients. |
2 puffs of Desmopressin nasal spray in both nostrils 90 minutes prior to surgery to reduce bleeding intraoperatively. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Candidates of FESS due to chronic rhinosinusitis(with & without polyposis)
Candidates with chronic rhinosinusitis with no response to medical therapy
Candidates with normal preoperative serum and urine sodium levels
Candidates with normal coagulation profile
|
|
| ExclusionCriteria |
| Details |
Revision FESS
Coagulopathies, bleeding disorders
Candidates on anticoagulants, vitamin E, diuretics , herbal medicines
Known allergy to desmopressin
Uncontrolled hypertension,cerebrovascular disease, significant coronary artery diseases or arrythmias
Compromised renal and hepatic function
Hyponatremia
Diabetes , seizure disorders
Sinonasal tumors
Pregnancy
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effects of topical Desmopressin as a premedication, on intraoperative bleeding and quality of surgical field during FESS. |
Every 15 minutes intraoperatively till the end of surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of topical Desmopressin on hemodynamic parameters. |
Every 15 minutes intraoperatively till the end of surgery. |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Chronic rhinosinusitis is a long term inflammatory condition that affects the mucosa of the nose and paranasal sinuses chronic rhinosinusitis can be associated with nasal polyposis or without nasal polyposis If patient does not respond well to the maximum drug treatment and having nasal polys functional endoscopic sinus surgery FESS will be the treatment of choice FUNCTIONAL ENDOSCOPIC SINUS SURGERY is a non invasive or minimally invasive surgical procedure which restores the paranasal sinus function it re establishes physiological pattern of ventilation and mucociliary clearance Multiple techniques are already in use to improve surgical field by reducing blood loss like hypotensive anesthesia GA bipolar diathermy topical vasoconstrictors local injection of epinephrine reverse Trendelenburg position None of them permanently provide an ideal surgical field Bleeding in FESS remains a challenge for surgeons and anesthesiologists Desmopressin is 1-deamino-8-D-arginine vasopressin is a synthetic peptide and selective V2 agonist synthetic analogue of the antidiuretic hormone L-arginine vasopressin it affects hemostasis through increasing plasma concentrations of tissue plasminogen activator and endothelial factor VIII von willebrands factor thus improving platelet adhesiveness exerting a probable effect on vascular stability Recently hemostatic effects of desmopressin have been considered by surgeon Unique feature of desmopressin its abilitity to create a localized effect focusing its action specifically at the site of bleeding without affecting the systemic hemostasis is utilized in this study So this study is conducted to evaluate the effect of intranasal desmopressin spray as a premedication before functional endoscopic sinus surgery as a noninvasive technique and with minimal adverse effects to improve quality of surgical field |