| CTRI Number |
CTRI/2025/07/090988 [Registered on: 16/07/2025] Trial Registered Prospectively |
| Last Modified On: |
15/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
A study comparing dexmedetomidine and remifentanil on blood pressure and recovery in patients undergoing endoscopic sinus surgery (FESS).
|
|
Scientific Title of Study
|
A comparative study of the effects of dexmedetomidine and remifentanil on perioperative hemodynamics and recovery profile in patients undergoing 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 |
Medampudi Bhargavii |
| Designation |
Post graduate student |
| Affiliation |
IMS and SUM Hospital |
| Address |
Department of Anaesthesiology and Critical care, first floor, IMS and
SUM Hospital, Siksha O Anusandhan, K8, Kalinga Nagar,
Bhubaneshwar
Khordha
ORISSA
751003
India
Khordha
ORISSA
751003
India |
| Phone |
8985228181 |
| Fax |
|
| Email |
bhargavi.medampudi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prerna Biswal |
| Designation |
Professor |
| Affiliation |
IMS and SUM Hospital |
| Address |
Department of Anaesthesiology and Critical care, first floor, IMS and
SUM Hospital, Siksha O Anusandhan, K8, Kalinga Nagar,
Bhubaneshwar
Khordha
ORISSA
751003
India
Khordha
ORISSA
751003
India |
| Phone |
9078671478 |
| Fax |
|
| Email |
prerna.biswal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prerna Biswal |
| Designation |
Professor |
| Affiliation |
IMS and SUM Hospital |
| Address |
Department of Anaesthesiology and Critical care, first floor, IMS and
SUM Hospital, Siksha O Anusandhan, K8, Kalinga Nagar,
Bhubaneshwar
Khordha
ORISSA
751003
India
Khordha
ORISSA
751003
India |
| Phone |
9078671478 |
| Fax |
|
| Email |
prerna.biswal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of medical Sciences and SUM Hospital, Siksha O Anusandhan, Bhubaneswar, Khordha,
Odisha, India, Pin 751003 |
|
|
Primary Sponsor
|
| Name |
Institute of medical sciences and SUM hospital |
| Address |
Department of Anaesthesiology and Critical care, first floor, IMS and
SUM Hospital, Siksha O Anusandhan, K8, Kalinga Nagar,
Bhubaneshwar
Khordha
ORISSA
751003
India |
| Type of Sponsor |
Private medical college |
|
|
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 Medampudi Bhargavi |
Institute of Medical Sciences and SUM Hospital, Siksha O Anusandhan |
Department of
Anaesthesiology,
Orthopedics OT in
Modular 3 complex, first
floor, Institute of
medical Sciences and
SUM Hospital, Siksha
O Anusandhan,
Bhubaneswar,
Khordha, Odisha, India,
Pin 751003
Khordha
ORISSA
Khordha
ORISSA |
8985228181
Bhargavi.medampudi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comittee Institute of Medical Sciences and Sum hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A: Dexmedetomidine (DEM)
|
Dose: 1 µg/kg IV loading over 10 minutes before induction, followed by 0.5 µg/kg/hr infusion
Route: Intravenous
Frequency: Single loading dose followed by continuous infusion
Duration: Approx. 60–90 minutes (until end of surgery) |
| Comparator Agent |
Group B: Remifentanil (REM) |
Dose: 1 µg/kg IV loading over 10 minutes before induction, followed by 0.5 µg/kg/min infusion
Route: Intravenous
Frequency: Single loading dose followed by continuous infusion
Duration: Approx. 60–90 minutes (until end of surgery) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients scheduled for elective Functional Endoscopic Sinus Surgery (FESS).
Gender: Male and female participants.
Age Range: 18 to 60 years.
Body Mass Index (BMI): Less than 30 kilograms per square meter (kg/m²).
ASA Physical Status Classification: Grade I and II according to the American Society of Anesthesiologists (ASA) guidelines.
|
|
| ExclusionCriteria |
| Details |
Patients who are not willing to participate
Patients under ASA 3 and ASA 4
Hemodynamic instability defined as intraoperative uncontrolled blood pressure more than 180 by 100 mmHg or less than 90 by 50 mmHg despite appropriate management
BMI greater than or equal to 30 kg per m2
Pregnant or lactating patients
Patients with conditions impairing effective communication and assessment |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare perioperative hemodynamic alterations, including pressure,
-heart rate,
- oxygen saturation(spo2)
2)To evaluate postoperative recovery using the Modified Aldrete Score. |
To compare perioperative hemodynamic alterations, including pressure,
-heart rate,
- oxygen saturation(spo2)
2)To evaluate postoperative recovery using the Modified Aldrete Score. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Postoperative Pain – Measured using the Visual Analog Scale (VAS)
Sedation Levels – Measured using the Richmond Agitation Sedation Scale (RASS)
Intraoperative Bleeding – Measured by estimating the amount of blood loss or by surgeon assessment
Surgeon Satisfaction – Measured using the Likert Scale |
Postoperative Pain (VAS)
Immediately postoperatively in PACU
30 minutes postoperatively
1 hour postoperatively
2 hours postoperatively
4 hours postoperatively
6 hours postoperatively
Sedation Levels (RASS)
Preoperative baseline
Every 15 minutes intraoperatively
15, 30, 45, and 60 minutes postoperatively
Intraoperative Bleeding
During the surgery (measured continuously or at defined intervals during the procedure)
Surgeon Satisfaction (Likert Scale)
Immediately after surgery (at the end of the procedure) |
|
|
Target Sample Size
|
Total Sample Size="85"
Sample Size from India="85"
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)
|
01/06/2026 |
| 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
|
A prospective randomized comparative clinical trial was conducted over 12 months at IMS and SUM Hospital Bhubaneswar by the Department of Anesthesiology in collaboration with the Department of ENT for patients undergoing Functional Endoscopic Sinus Surgery FESS. A total of 88 patients aged 18 to 60 years classified as ASA I and II were randomly assigned into two groups of 44 each using a computer-generated randomization table. Group DEM received Dexmedetomidine 1 mcg per kg as a loading dose over 10 minutes followed by a saline bolus of 5 mL before induction and a maintenance infusion of 0.5 mcg per kg per min. Group REM received a saline placebo over 10 minutes Remifentanil 1 mcg per kg as a loading dose before induction and a maintenance infusion of 0.5 mcg per kg per min. Preoperative assessment included history physical examination airway assessment ASA grading and baseline vital signs. Patients were preoxygenated with 100 percent oxygen at 10 L per min for 3 minutes and IV access was secured using an 18G cannula with fluid preload of Ringers Lactate 10 mL per kg. Premedication included IV Glycopyrrolate 0.2 mg Midazolam 1 mg Pantoprazole 40 mg and Ondansetron 4 mg. Induction was achieved with Propofol 1.5 to 2 mg per kg and Vecuronium 0.1 mg per kg followed by endotracheal intubation. Anesthesia was maintained with Isoflurane oxygen air and additional Vecuronium as required. End tidal CO2 was maintained between 35 and 45 mmHg. Hemodynamic parameters including BP HR SpO2 and ECG were recorded at baseline every 5 minutes for the first 15 minutes and then every 15 minutes thereafter. At the end of surgery study drugs were stopped and reversal was achieved using Sugammadex 2 mg per kg followed by extubation upon adequate recovery. Postoperative recovery was assessed every 10 minutes for 60 minutes focusing on RASS VNRS and adverse events. In the PACU RASS was monitored every 15 minutes during the first hour then every 30 minutes until discharge. A Modified Aldrete Score of 9 or higher was required for PACU discharge. |