FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/05/042615 [Registered on: 18/05/2022] Trial Registered Prospectively
Last Modified On: 13/05/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   comparison of intravenous dexmedetomidine versus magnesium sulphate for controlled hypotension in functional endoscopic sinus surgery 
Scientific Title of Study   Efficacy of intravenous dexmedetomidine versus magnesium sulphate for controlled hypotension in functional endoscopic sinus surgery: A randomized double blind study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr kaviyarasan 
Designation  pg student 
Affiliation  PT. JNM Medical college 
Address  Dept.of Anaesthesiology ans pain medicine pt.JNM Medical college Raipur CHHATTISGARH 492001
Dept.of Anaesthesiology ans pain medicine pt.JNM Medical college Raipur CHHATTISGARH 492001
Raipur
CHHATTISGARH
492001
India 
Phone  6381805624  
Fax    
Email  kaviyarasanarumugam1927@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rashmi Thakur 
Designation  Associate Proffessor 
Affiliation  PT. JNM Medical college 
Address  Dept.of Anaesthesiology ans pain medicine pt.JNM Medical college Raipur CHHATTISGARH 492001
Dept.of Anaesthesiology ans pain medicine pt.JNM Medical college Raipur CHHATTISGARH 492001
Raipur
CHHATTISGARH
492001
India 
Phone  9827485021  
Fax    
Email  rash15nov@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rashmi Thakur 
Designation  Associate Proffessor 
Affiliation  PT. JNM Medical college 
Address  Dept.of Anaesthesiology ans pain medicine pt.JNM Medical college Raipur CHHATTISGARH 492001
Dept.of Anaesthesiology ans pain medicine pt.JNM Medical college Raipur CHHATTISGARH 492001
Raipur
CHHATTISGARH
492001
India 
Phone  9827485021  
Fax    
Email  rash15nov@gmail.com  
 
Source of Monetary or Material Support  
Dr Bhimrao Ambedkar Memorial Hospital Raipur 
 
Primary Sponsor  
Name  Dr Rashmi Thakur 
Address  Dept.of Anaesthesiology ans pain medicine pt.JNM Medical college Raipur CHHATTISGARH 492001  
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 Kaviyarasan  Dr Bhimrao Ambedkar Memorial Hospital Raipur  Pt.JNM Medical college Raipur
Raipur
CHHATTISGARH 		 6381805624

kaviyarasanarumugam1927@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee PT JNM Medical college Raipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: J310||Chronic rhinitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dexmeditomidine  dexmedetomidine 1 µg/kg over 10 min followed by infusion at 0.2 to 0.7 µg/kg/hr  
Comparator Agent  Magnesium sulphate   Magnesium sulphate 40mg/kg over 10 mins followed by infusion at 10 to 15 mg/kg/hr 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. ASA Physical status – l and ll
2.Patients undergoing functional endoscopic sinus surgery
3. Weight 55-85 kg
 
 
ExclusionCriteria 
Details  1. Patient’s refusal
2. Hypersensitivity to study drugs
3. Patients with recurrent sinus surgery
4. Anemia (hemoglobin concentration < 8gm/dl)
5. patients with coagulopathies
6. systemic hypertension
7. Sinus bradycardia
8.Cardiovascular diseases, Renal diseases, Central nervous system diseases, and Hepatic diseases
9. Novel corona virus positive
10. Known history of substance abuse or alcohol abuse
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Quality of surgical field as accessed by average category scale in terms of bleeding and dryness  intra operative period 
 
Secondary Outcome  
Outcome  TimePoints 
Amount of blood loss
Surgeons satisfaction score regarding bloodless field
Side effects and complications
 
 		 intra operative period to post operative recovery time 
 
Target Sample Size   Total Sample Size="92"
Sample Size from India="92" 
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)   20/05/2022 
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="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

This is a interventional prospective  randomized double-blind study of comparison between magnesium sulphate versus dexmedetomidine for controlled hypotension in FESS between age group 18 to 60yrs with ASA Physical status I&II with patients undergoing Functional Endoscopic Sinus Surgery. It will be conducted at single center in India. Primary outcome measures will be Quality of surgical field as accessed by average category scale in terms of bleeding and dryness and secondary outcome measures will be amount of blood loss and surgeon’s satisfaction score regarding bloodless field and side effects and complications.

 
Close