| 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
|
|
|
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
|
|
|
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. |