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CTRI Number  CTRI/2024/05/067369 [Registered on: 15/05/2024] Trial Registered Prospectively
Last Modified On: 26/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effectivenessof intranasal vs intravenous dexmedetomidine infusion providing induced hypotension in functional endoscopic sinus surgery(FESS)-A clinical trial 
Scientific Title of Study   comparison of intranasal and intravenous dexmedetomidine infusion in providing induced hypotension in functional endoscopic sinus surgery(FESS)-A Randomised double blind trial 
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 RAM PANDIAN G 
Designation  Post graduate student  
Affiliation  Sri Balaji vidyapeeth university 
Address  211, department of anaesthesiology,Mahatma Gandhi medical college and research institute,Pillayarkuppam,pondicherry-607402
211, department of anaesthesiology,Mahatma Gandhi medical college and research institute,Pillayarkuppam,pondicherry-607402
Pondicherry
PONDICHERRY
607402
India 
Phone  7397638717  
Fax    
Email  Rampandian30@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR GAYATRI MISHRA 
Designation  PROFESSOR  
Affiliation  Sri Balaji vidyapeeth university 
Address  211, department of anaesthesiology,Mahatma Gandhi medical college and research institute,Pillayarkuppam,pondicherry-607402
211, department of anaesthesiology,Mahatma Gandhi medical college and research institute,Pillayarkuppam,pondicherry-607402
Pondicherry
PONDICHERRY
607402
India 
Phone  9894354068  
Fax    
Email  drgayatrimishra@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR RAM PANDIAN G 
Designation  POST GRADUATE STUDENT  
Affiliation  Sri Balaji vidyapeeth university 
Address  211, department of anaesthesiology,Mahatma Gandhi medical college and research institute,Pillayarkuppam,pondicherry-607402
211, department of anaesthesiology,Mahatma Gandhi medical college and research institute,Pillayarkuppam,pondicherry-607402
Pondicherry
PONDICHERRY
607402
India 
Phone  7397638717  
Fax    
Email  Rampandian30@gmail.com  
 
Source of Monetary or Material Support  
Mahatma Gandhi medical college hospital and research institute, Pillaiarkuppam, INDIA 607402 
 
Primary Sponsor  
Name  DR RAM PANDIAN G 
Address  Mahatma Gandhi Medical College and Research Institute, pillaiyarkuppam Pondicherry - 607402 India. 
Type of Sponsor  Other [Self] 
 
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 Ram pandian G  Mahatma Gandhi medical college and research institute   211, department of anaesthesiology,Mahatma Gandhi medical college and research institute,Pillayarkuppam,pondicherry-607402
Pondicherry
PONDICHERRY 
7397638717

Rampandian30@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Mahatma Gandhi medical college and research institute   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H60-H95||Diseases of the ear and mastoid process,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Intranasal Dexmedetomidine  0.9% 100ml NS will be administered bolus iv followed by iv infusion of 50ml Intranasal Dexmedetomidine drop will be instilled into each Nostril at 1mcq/kg in equally divided doses via Atomizer 
Intervention  Intravenous Dexmedetomidine  Inj. Dexmedetomidine at dose of 1 mcg/kg bolus,before 30min of induction over a period of 10min in 0.9% 100ml saline,followed by infusion 0.4mcg/kg/hr 100 mcg dexmed in 50ml NS after noting the baseline hemodynamic 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients belonging to ASA 1 and ASA 2 physical status, surgery duration of less than 3hours 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
To compare the Target MAP to achieve bloodless field in the two group of
patients(IV &IN Dexmedotimine group) 
At baseline,5mins,10mins,15mins,30mins,
1hours,1:30hours,2hours,2:30hours,3hours and postoperatively 30min,1hour,1:30hour,2hours 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   16/06/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  
Functional endoscopic sinus surgery is a minimally invasive procedure and considered
to be the primary approach used today for the surgical treatment of chronic sinusitis and
sinonasal polyps that is commonly performed under controlled hypotensive anesthesia. In
FESS surgeries,due to excessive bleeding which leads to impaired visibility of the operative
field and various complications. So a dry operative field is necessary for a more definitive
removal of the polyp (lesion) ,so the vital structures less damaged and thereby tissue
infection is also minimized. Controlled hypotension is a technique used to limit
intraoperative blood loss and provide the best possible field for surgery.
Induced or Controlled hypotension is a technique in which the arterial blood pressure is
decreased in a predictable and deliberate manner. The intent of deliberate hypotension is to
reduce bleeding that facilitate surgery and to decrease the need for blood transfusion
The target of induced hypotension is (60-70mmhg), Hypotension is defined as MAP
<55mmHg.Several drugs have been used successfully to produce controlled hypotension IN
FESS during general anesthesia for example inhalational anesthetics, direct vasodilators
(sodium nitroprusside and nitroglycerin), beta adrenergic antagonists (propranolol 2 and
esmolol), alpha adrenergic agonists (clonidine and dexmedetomidine), calcium channel
blockers, prostaglandin E1 (alprostadil), adenosine[1] and l-receptors agonists
(remifentanil).
IV Dexmeditomedine infusion has been studied in various surgery in producing
controlled hypotension The newer α2-adrenergic agonist Dexmedetomidine was introduced
in the market in 1999 for sedating patients on mechanical ventilation those who are
admitted in intensive care units, Later it was approved by FDA for ICU
sedation.Dexmedetomidine is an α2-2 adrenergic receptor agonist with sedative, anxiolytic,
sympatholytic, and devoid of respiratory depression and analgesic effects best described as
opiod sparing,Dexmeditomedine is rapid in onset and short acting,though intravenous
dexmeditomedine infusion has been studied extensively in doses ranging from 0.4-
0.6mcg/kg in FESS surgery Previous studies have reported that intranasal DEX 1–
1.5mcg/kg produced significant sedation within 45–60 min and its elimination half-life was
114 min in healthy volunteers.
Though Intranasal DEXMED Dose range to 1 to 3mcg/kg in paediatrics has been
studied for premedicaton in paediatrics as,well as in adults including elderly in reducing
agitation,pain and haemodynamic stability,,its use in FESS surgery not being studied.hence
we would like to compare efficacy of intranasal dexmed versus intravenous dexmed
infusion in providing induced hypotension analgesic and bloodless surgical field in FESS
surgery 
 
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