| CTRI Number |
CTRI/2025/11/097176 [Registered on: 11/11/2025] Trial Registered Prospectively |
| Last Modified On: |
09/11/2025 |
| 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
|
To compare the effectiveness between two drugs- dexmedetomidine and remifentanil- for keeping around fifty patients with a seemingly difficult airway calm and comfortable during the awake placement of a breathing tube with the help of a visualizing scope into their windpipe in the first attempt |
|
Scientific Title of Study
|
A Prospective Comparative Study Between
Dexmedetomidine And Remifentanil For Sedation In Awake Fibreoptic
Nasotracheal Intubation |
| 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 N Hemapriya |
| Designation |
PG Resident |
| Affiliation |
M S Ramaiah Medical College |
| Address |
Department of Anaesthesiology, MS Ramaiah Medical College,
MSRIT Post, Bangalore- 560054
Bangalore
KARNATAKA
560054
Bangalore
KARNATAKA
560054
India |
| Phone |
9108270047 |
| Fax |
|
| Email |
hemapriyanandakumar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Geetha C R |
| Designation |
Professor |
| Affiliation |
M S Ramaiah Medical College |
| Address |
Department of Anaesthesiology, MS Ramaiah Medical College,
MSRIT Post, Bangalore- 560054
Bangalore
KARNATAKA
560054
India |
| Phone |
9900482828 |
| Fax |
|
| Email |
jageedha@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Geetha C R |
| Designation |
Professor |
| Affiliation |
M S Ramaiah Medical College |
| Address |
Department of Anaesthesiology, MS Ramaiah Medical College,
MSRIT Post, Bangalore- 560054
Bangalore
KARNATAKA
560054
India |
| Phone |
9900482828 |
| Fax |
|
| Email |
jageedha@yahoo.com |
|
|
Source of Monetary or Material Support
|
| M S Ramaiah Medical College,
New BEL Road, M S Ramaiah Nagar, MSRIT Post, Bengaluru-560054,Karnataka, India. |
|
|
Primary Sponsor
|
| Name |
MS Ramaiah Medical College |
| Address |
MS Ramaiah Medical College
New BEL Road, MSRIT post, Bangalore- 560054 |
| 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 N Hemapriya |
M S Ramaiah Medical College And Hospital |
Department of
Anaesthesiology,
Second floor, MS
Ramaiah Medical
College, New BEL
Road, Bangalore -
560054
Bangalore
KARNATAKA
Bangalore
KARNATAKA |
9108270047
hemapriyanandakumar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| M S Ramaiah Medical College Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M489||Spondylopathy, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine for sedation in awake fibreoptic nasotracheal intubation |
Dexmedetomidine loading dose of 0.4mcg/kg at a concentration of 2mcg/cc over 10minutes followed by a continuous infusion dose of 0.7mcgs/kg/hour at a concentration of 2mcgs/cc for sedation during awake fibreoptic nasotracheal intubation |
| Comparator Agent |
Remifentanil for sedation in awake fibreoptic nasotracheal intubation |
Remifentanil loading dose of 0.75mcg/kg at a concentration of 20mcg/cc followed by continuous infusion dose of 0.075mcg/kg/hour at a concentration of 20mcg/cc for sedation during awake fibreoptic nasotracheal intubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. 18-75 year olds
2. ASA I-III
3. Maxillofacial trauma patients
4. Patients with oral carcinoma
5. Trismus |
|
| ExclusionCriteria |
| Details |
1. Nasal trauma
2. Pregnant and lactating women
3. Heart Rate less than 50 bpm
4. AV block on ECG
5. History of angina
6. Liver cirrhosis
7. History of long time opioid use or use within last 14days
8. Allergy to drugs |
|
|
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 |
| first attempt success rate and quality of intubation |
Time interval between sedation and confirmation of ventilation with end tidal carbon dioxide being displayed on the monitor, in the first attempt, approximately 10minutes after the loading dose is completed |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| time required to achieve RSS of 2 |
interval between start of sedation to when patient is cooperative, oriented & tranquil, approximately 5minutes after the loading dose is completed |
| Total duration for successful tracheal intubation |
sum of all attempts taken to successfully intubate the patient endotracheally, approximately 15minutes after the loading dose is completed |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
01/12/2025 |
| 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="8"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - None of the above
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [hemapriyanandakumar@gmail.com].
- For how long will this data be available start date provided 04-01-2027 and end date provided 04-01-2033?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The Difficult Airway Society (DAS) recommends considering awake fiberoptic nasotracheal intubation (AFONTI) for patients with a predicted difficult airway as they are at risk of complications during airway management under general anaesthesia. The core principles of AFONTI include maintaining oxygenation, ensuring adequate topical anaesthesia of the airway, performing the procedure efficiently, and, when necessary, using sedation as majority of the patients are uncooperative. AFONTI performed in the absence of a sedative is extremely uncomfortable, calling for the need of controlled sedation. Sedation used cautiously can help reduce anxiety and discomfort, provide amnesia, and enhance procedural tolerance. The ideal sedative should be short-acting, easy to titrate, and provide adequate sedation with amnesia while ensuring spontaneous ventilation by reducing the patient’s airway reflex response like coughing and laryngospasm. Controlled sedation maintains physiological hemodynamic parameters thereby guaranteeing patient cooperation and comfort. However, sedation also carries risks such as airway obstruction, oxygen desaturation, and cardiovascular instability. Therefore, careful selection of drug regimens is crucial to ensure safe and effective AFONTI. The most commonly used sedatives for this setting include benzodiazepines, ketamine, propofol, sevoflurane, dexmedetomidine, and remifentanil. Dexmedetomidine (D), a selective alpha 2 adrenergic G protein coupled receptor agonist, acting on the postsynaptic alpha 2 receptors in the locus coeruleus attributing its sedative, anxiolytic, amnestic and sympatholytic properties. D also influences the release of substance P from dorsal horn of spinal cord attributing its analgesic properties. D has a short distribution half-life of 6 minutes and a terminal elimination half life of 2 hours.
Remifentanil (R) is an ultra-short-acting opioid with selective mu receptor agonist properties, offering sedative, strong analgesic effects and antitussive properties. R has rapid onset and redistribution half-life of 3 minutes as it is metabolized by non-specific plasma esterases and elimination half-life of 6 minutes ensuring quick recovery and attenuation of stress responses allowing easier patient communication. Pharmacokinetics of R vary with age and lean body mass while pharmacodynamics varies only with age.
In this study, which is a randomized control trial with a sample size of 50 that will be conducted in MS Ramaiah Medical College, Bangalore, we aim to compare the effectiveness of Dexmedetomidine and Remifentanil as sole sedative agents for AFONTI with the hypothesis that Remifentanil with its higher analgesic efficacy and anti-tussive property, may provide more favourable intubation conditions yielding higher first attempt success rates.
The primary outcome will be the first attempt success rate and quality of intubation assessed by a 5 point intubation score depicted by 1for No movement, 2 for Grimacing, 3 for Mild cough , 4 for Major limb movement and 5 for Prolonged coughing.
The secondary outcome will be based on, • Time required to achieve a Ramsay Sedation Score (RSS) of 2 with RSS ranging from 1 to 6 depicted by 1 for Patient is anxious, agitated, or restless, 2 for Patient is cooperative, oriented, and tranquil, 3 for Patient responds to commands only, 4 for Patient exhibits a brisk response to a light glabellar (between the eyebrows) tap or a loud auditory stimulus, 5 for Patient exhibits a sluggish response to a light glabellar tap or a loud auditory stimulus and 6 for Patient exhibits no response to stimulus. • Patient tolerance to endotracheal tube. • Total duration for successful tracheal intubation. • Hemodynamic parameters |