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CTRI Number  CTRI/2025/09/094201 [Registered on: 03/09/2025] Trial Registered Prospectively
Last Modified On: 03/09/2025
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   Study comparing two doses of a commonly used anaesthesia drug (Dexmedetomidine) to control bleeding during sinus surgery. 
Scientific Title of Study   A Comparative Study of Two Different Doses of Dexmedetomidine for Hypotensive Anaesthesia in Patients Undergoing Functional Endoscopic Sinus Surgery 
Trial Acronym  NILL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kaushik M 
Designation  PG Student 
Affiliation  Naruvi Hospitals 
Address  Naruvi Hospitals Collectors Office Road Bangalore Chennai National Highway NH 48 Vellore

Vellore
TAMIL NADU
632004
India 
Phone  7358941366  
Fax    
Email  mkaushik9@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Ramya Deepika D 
Designation  Senior Consultant 
Affiliation  Naruvi Hospitals 
Address  Naruvi Hospitals Collectors Office Road Bangalore Chennai National Highway NH 48 Vellore

Vellore
TAMIL NADU
632004
India 
Phone  7898971326  
Fax    
Email  drramyadeepika@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Kaushik M 
Designation  PG Student 
Affiliation  Naruvi Hospitals 
Address  Naruvi Hospitals Collectors Office Road Bangalore Chennai National Highway NH 48 Vellore

Vellore
TAMIL NADU
632004
India 
Phone  7358941366  
Fax    
Email  mkaushik9@gmail.com  
 
Source of Monetary or Material Support  
Naruvi Hospitals Collectors Office Road Bangalore Chennai National Highway NH 48 Vellore 632004 
 
Primary Sponsor  
Name  Naruvi Hospitals 
Address  Collectors Office Road Bangalore Chennai National Highway NH 48 Vellore 632004 
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 Kaushik M  Naruvi Hospitals  Department of Anaesthesia 4th Floor OT Complex Collectors Office Road Bangalore Chennai National Highway NH 48 Vellore 632004
Vellore
TAMIL NADU 
7358941366

mkaushik9@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board (IRB) of Naruvi Hospitals, Vellore, India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J32||Chronic sinusitis, (2) ICD-10 Condition: J33||Nasal polyp, (3) ICD-10 Condition: J34||Other and unspecified disorders ofnose and nasal sinuses,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dexmedetomidine  Group A - Intravenous dexmedetomidine 0.25 microgram per kilogram body weight, administered as a bolus infusion over 30 minutes after induction of general anaesthesia. 
Comparator Agent  Dexmedetomidine  Group B - Intravenous dexmedetomidine 0.5 microgram per kilogram body weight, administered as a bolus infusion over 30 minutes after induction of general anaesthesia. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients aged 18 to 65 years undergoing elective FESS under general anaesthesia. American Society of Anesthesiologists (ASA) Class I and II (patients with no comorbidities or well-controlled comorbidities).
 
 
ExclusionCriteria 
Details  ASA Class III and above. Patients aged less than 18 years or more than 65 years. Patients with severe cardiac dysfunction or conduction blocks. Patients allergic to study drugs. Patients with coagulopathies or uncontrolled hypertension. Patients unwilling to participate in the study. Patients with cognitive or psychiatric disturbances. Patients requiring postoperative ventilation. Duration of Surgery longer than 2.5 hours
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the proportion of 5-minute non-invasive blood pressure (NIBP) readings achieving the target mean arterial pressure (MAP) during surgery (from induction to extubation) between the two dexmedetomidine groups (0.25 mcg/kg vs. 0.5 mcg/kg).  Assessed intraoperatively, from induction of anaesthesia until extubation, with MAP recorded every 5 minutes. 
 
Secondary Outcome  
Outcome  TimePoints 
Postoperative sedation measured using the Ramsay Sedation Score every 15 minutes for the first hour post-extubation. The mean score per patient is compared between groups.  Assessed at 15, 30, 45, & 60 minutes after extubation in the recovery room. 
To evaluate the incidence of intraoperative adverse effects (hypotension, defined as a single 5-minute NIBP reading with MAP less than 55 mmHg, or bradycardia, HR less than 60 per min) as a safety measure.  Assessed intraoperatively, from induction of anaesthesia until extubation. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 4 
Date of First Enrollment (India)   15/09/2025 
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="6"
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 (FESS) is a commonly performed procedure where a bloodless surgical field is critical for success. Controlled hypotensive anaesthesia is often used to minimize intraoperative bleeding and improve visualization. Dexmedetomidine, a selective alpha 2 adrenergic agonist, is widely employed for this purpose due to its sedative, analgesic, and sympatholytic properties. However, the optimal bolus dose for achieving effective hypotension with minimal adverse effects remains unclear.

This prospective, randomized, double blind, active controlled study aims to compare the efficacy and safety of two different bolus doses of intravenous dexmedetomidine, 0.25 microgram per kilogram and 0.5 microgram per kilogram, administered over 30 minutes after induction of general anaesthesia in patients undergoing elective FESS. Sixty patients aged 18 to 65 years, ASA physical status I or II, will be randomly allocated into two groups of 30 each using computer generated randomization with allocation concealment.

The primary outcome will be the proportion of intraoperative mean arterial pressure readings within the target range, defined as 55 to 65 mmHg for non hypertensive patients, or 15 to 20 percent below baseline mean arterial pressure for controlled hypertensives. Secondary outcomes will include postoperative sedation assessed by Ramsay Sedation Score, and incidence of adverse events such as hypotension and bradycardia.

The study seeks to determine whether either of the two lower bolus doses of dexmedetomidine, 0.25 or 0.5 microgram per kilogram, is sufficient to achieve controlled hypotension during FESS with fewer adverse effects when compared to higher doses reported in previous studies.

 
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