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CTRI Number  CTRI/2025/03/082570 [Registered on: 18/03/2025] Trial Registered Prospectively
Last Modified On: 18/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparative study of two different doses of dexmedetomidine for producing programmed hypotension during Functional endoscopic sinus surgery 
Scientific Title of Study   A comparative evaluation of two different doses of Dexmedetomidine in producing controlled hypotension 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.Mehjebin Ahmed 
Designation  Post graduate trainee 
Affiliation  Silchar Medical College and Hospital 
Address  Department of anaesthesiology and critically care, Silchar medical college and hospital, ghungoor, Silchar

Cachar
ASSAM
788014
India 
Phone  7099426547  
Fax    
Email  mehjebin92@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR Suneeta Dutta 
Designation  Head of department 
Affiliation  Silchar medical college and Hospital 
Address  Department of anaesthesiology and critically care, Silchar medical college and hospital, ghungoor, Silchar, Assam

Cachar
ASSAM
788014
India 
Phone  9435074110  
Fax    
Email  drsuneetadutta@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR SUNEETA DUTTA 
Designation  HEAD OF DEPARTMENT 
Affiliation  SILCHAR MEDICAL COLLEGE AND HOSPITAL 
Address  Department of anaesthesiology and critical care Silchar medical college and hospital Silchar assam

Cachar
ASSAM
788014
India 
Phone  9435074110  
Fax    
Email  drsuneetadutta@gmail.com  
 
Source of Monetary or Material Support  
Silchar medical college and hospital, Silchar 788014, cachar, Assam india 
 
Primary Sponsor  
Name  DR Mehjebin Ahmed 
Address  Department of anaesthesiology and critically care, Silchar medical college and hospital, ghungoor, Silchar assam india pin 788014 
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 Suneeta Dutta  Silchar medical college and hospital  Department of anaesthesiology and critically care, Silchar medical college and hospital, ghungoor, Silchar
Cachar
ASSAM 		 9435074110

drsuneetadutta@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE OF SILCHAR MEDICAL COLLEGE & HOSPITAL  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J014||Acute pansinusitis, (2) ICD-10 Condition: J010||Acute maxillary sinusitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  comparison between two different doses of dexmedetomidine in fess for controlled hypotension  AIM -The aim of the study is to find the optimum dose of dexmeditomedine required in bringing controlled hypotension for FESS .  
Intervention  Two different doses of dexmedetomidine for controlled hypotension in FESS  Patient will induced by propofol( 2-3 mg/kg ) followed by succinyl choline (1.2 to 1.5 mg /kg body weight). Laryngoscopy will be done followed by ETT insertion. Position of the tube will fixed and confirmed by bilateral air entry positive. Patient will be maintain with 4:2 ratio of N2O :O2 and inj vecuronium (.06-0.1mg/kg body weight). Group A- 15 patients received bolus dose of dexmedetomidine 1micro gm/kg iv followed by continuous iv infusion of 0.2 microgm/kg/hr. Group B- 15 patients received bolus dose of 1 micro gm/kg iv and continuous iv infusion of 0.4 micro gm/kg/hr dexmedetomidine Group C- 15 Patients received bolus dose of dexmedetomidine and saline infusion.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patients of all sex
Elective FESS surgeries
aged from 18 years to 50 years.
Patients with ASA Grade I and II physical status
 
 
ExclusionCriteria 
Details  • Patient refusal
• Pregnancy
• Any known allergic condition or contraindication to GA,
• Hypertensive patient undergoing antihypertensive medication
• Any cardio vascular, renal disease
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
to evaluate and compare the following factor in two different dose group for dexmedetomidine-
1.mean arterial pressure
2. heart rate variability
3. bleeding
4. time taken to induce hypotension 		 Time taken to induce hypotension 
 
Secondary Outcome  
Outcome  TimePoints 
amount of bleeding  intraoperative 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
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 
Date of First Enrollment (India)   29/03/2025 
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 surgery of sinus included bleeding in surgical field. by using dexmedetomidine to induce  hypotension causes less  surgical field bleeding. to find out the appropriate dose  of dexmedetomidine during intraoperative period among two different dose. 
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