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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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
 
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