| CTRI Number |
CTRI/2025/05/087160 [Registered on: 20/05/2025] Trial Registered Prospectively |
| Last Modified On: |
17/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Dexmedetomidine and Remifentanil medications used to keep patients calm and comfortable while they are awake during a placement of breathing tube in difficult patients |
|
Scientific Title of Study
|
Comparasion of dexmedetomidine and remifentanil for sedation during awake fibre-optic intubation in patients with difficult airway- a randomized clinical control trial |
| 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 Prasanth Sai Vangapulusu |
| Designation |
Post Graduate student |
| Affiliation |
IMS AND SUM HOSPITAL |
| Address |
Dept of Anesthesia, IMS AND SUM HOSPITAL, Siksha O Anusandhan University, Kalinganagar, Bhubaneswar
Khordha ORISSA 751003 India |
| Phone |
7032393230 |
| Fax |
|
| Email |
prasanthsai000@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ranjita Acharya |
| Designation |
Professor |
| Affiliation |
IMS AND SUM HOSPITAL |
| Address |
Dept of Anesthesia, IMS AND SUM HOSPITAL, Siksha O Anusandhan University, Kalinganagar, Bhubaneswar
Khordha ORISSA 751003 India |
| Phone |
8763421899 |
| Fax |
|
| Email |
drranjitaacharya@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Prasanth Sai Vangapulusu |
| Designation |
Post Graduate student |
| Affiliation |
IMS AND SUM HOSPITAL |
| Address |
Dept of Anesthesia, IMS AND SUM HOSPITAL, Siksha O Anusandhan University, Kalinganagar, Bhubaneswar
Khordha ORISSA 751003 India |
| Phone |
7032393230 |
| Fax |
|
| Email |
prasanthsai000@gmail.com |
|
|
Source of Monetary or Material Support
|
| IMS AND SUM HOSPITAL, Siksha O Anusandhan University, Bhubaneswar, Odisha, India, 751003 |
|
|
Primary Sponsor
|
| Name |
IMS and SUM Hospital |
| Address |
K8, Kalinganagar, Bhubaneswar, Odisha, 751003 |
| 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 Prasanth Sai Vangapulusu |
IMS AND SUM HOSPITAL |
Onco surgery OT, Dental OT, IMS AND SUM HOSPITAL, K8, Kalinganagar, Bhubaneswar, Odisha, 751003 Khordha ORISSA |
7032393230
prasanthsai000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, IMS 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 |
Dexmedetomidine |
Dexmedetomidine loading dose of 0.5µg/kg over 10 minutes Intravenously and continuous infusion at 0.3 µg/kg/hr Intravenously given till appropriate sedation level reached |
| Comparator Agent |
Remifentanil |
Remifentanil loading dose of 0.75µg/kg for 5 minutes Intravenously and continuous infusion at 0.15 µg/kg/min Intravenously given till appropriate sedation reached |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anesthesiologists grades 1 and 2,Undergoing oral cancer or dental surgeries,Patients with limited mouth opening of less than 2 fingers
|
|
| ExclusionCriteria |
| Details |
Patient not giving consent,known allergy to the anesthetics,Coagulation disorders,Pregnancy or breast feeding,Cardiovascular and neurological abnormalities,Non cooperative patients
Patients belonging to ASA more than 2,Patients with alcohol or drug use
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the ease of intubation between both the groups |
1 minute, 5 minute, 10 minute, 15 minute intervals |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess intubation comfort score,To study complications, cardio respiratory status intra operatively,Ramsay Sedation scale,Airway obstruction score,Time for Intubation |
1 minute, 5 minute, 10 minute, 15 minute intervals |
|
|
Target Sample Size
|
Total Sample Size="88" Sample Size from India="88"
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)
|
30/05/2025 |
| 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
|
Awake fiberoptic intubation AFOI is a well established technique for managing patients with difficult airways However the biggest challenge with AFOI is ensuring that patients are comfortable cooperative and not overly anxious while still maintaining their airway reflexes and spontaneous breathing
Dexmedetomidine a sedative that works on alpha2 adrenergic receptors is known for providing calmness pain relief and anxiety reduction without significantly affecting breathing On the other hand remifentanil a short acting opioid is commonly used for its strong pain relief and ability to suppress airway reflexes though it comes with a risk of respiratory depression if not carefully controlled
While both drugs are used in clinical practice for AFOI there is still no clear consensus on which one is better particularly in patients with difficult airways Since these patients are already at a higher risk of complications choosing the right sedation strategy could make a significant difference in their safety and comfort
Although previous studies have explored dexmedetomidine and remifentanil for AFOI most research has focused on patients with normal or mildly challenging airways There is limited evidence comparing these two sedatives specifically in cases where airway management is particularly difficult due to anatomical abnormalities trauma or other complications Additionally while both drugs are effective still dont have a clear understanding of which one provides a better balance between patient comfort intubation success and minimal side effects especially in high risk cases
Dexmedetomidine will offer a more stable sedation experience with fewer airway reflex disturbances better patient tolerance and more consistent hemodynamic stability compared to remifentanil |