| CTRI Number |
CTRI/2024/07/071652 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
30/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between two routes of drug administration in awake intubation |
|
Scientific Title of Study
|
A prospective randomised controlled study:comparing intravenous and nebulised Dexmedetomidine 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 Subhash Dahiya |
| Designation |
Professor |
| Affiliation |
Lala lajpat rai memorial medical College, Meerut |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY LLRM MEDICAL COLLEGE, MEERUT
Meerut
UTTAR PRADESH
250004
India |
| Phone |
9837056949 |
| Fax |
|
| Email |
drsubhashllrm@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Subhash Dahiya |
| Designation |
Professor |
| Affiliation |
Lala lajpat rai memorial medical College, Meerut |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, LLRM MEDICAL COLLEGE, MEERUT
Meerut
UTTAR PRADESH
250004
India |
| Phone |
9837056949 |
| Fax |
|
| Email |
drsubhashllrm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Namrata kaka |
| Designation |
Junior resident 2nd year |
| Affiliation |
Lala lajpat rai memorial medical College |
| Address |
Ground floor, Department of Anaesthesiology, LLRM Medical college, Meerut
Meerut
UTTAR PRADESH
250004
India |
| Phone |
8317085892 |
| Fax |
|
| Email |
namrata19412@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, LLRM Medical college, SVBP hospital, Meerut, India
Pin code-250004 |
|
|
Primary Sponsor
|
| Name |
Dr Namrata kaka |
| Address |
Ground floor, Department of Anaesthesiology, LLRM Medical college, Meerut, India
Pin code-250004 |
| Type of Sponsor |
Other [Self] |
|
|
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 Namrata kaka |
Sardar Vallabhbhai Patel Hospital |
Room no.14, ground floor, beside IT parking
Department of Anaesthesiology,
LLRM Medical college, Meerut, Uttar Pradesh
Meerut
UTTAR PRADESH |
8317085892
namrata19412@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
INTRAVENOUS DEXMEDETOMIDINE |
Pre-operative patient tolerance, hemodynamic responses, dose of lignocaine and propofol required and total intubation time is assessed after Dexmedetomidine 1mcg/kg administration by intravenous route for 10 minutes |
| Comparator Agent |
NEBULISED DEXMEDETOMIDINE |
Pre-operative patient tolerance, hemodynamic responses,dose of lignocaine and propofol required and total intubation time is assessed after Dexmedetomidine 1mcg/kg administration by nebulization route for 15 minutes |
| Intervention |
Using Dexmedetomidine as sedative agent to blunt responses for awake fibreoptic nasotracheal intubation |
Dexmedetomidine administration was done by two different routes-intravenous and nebulization and hemodynamic responses, ease of intubation, total time required for intubation, recall of procedure on post operative day 1 were compared |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA grade 1 and 2
2.Patients undergoing elective surgeries under general anaesthesia
3.Posted for surgery requiring supine position only |
|
| ExclusionCriteria |
| Details |
1.Patient refusal
2.Pregnancy
3.Emergency surgeries
4.Hemodynamically unstable patients
5.Patient with liver and kidney diseases, liver cirrhosis, thrombocytopenia, coagulopathies |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the sedation score after drug infusion and vocal cord movements for attempting awake fibreoptic intubation |
To assess hemodynamic responses at baseline, 2 minutes,4 minute,6 minutes, 8 minutes and 10 minutes after infusion and sedation score 10 minutes after drug infusion and vocal cord movements for attempting awake fibreoptic intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic responses to intubation |
Outcome assessed at
2 minutes after infusion
4 minutes after infusion
6 minutes after infusion
8 minutes after infusion
10 minutes after infusion
Fibrescope through nostril
ETT through nasopharynx
ETT through glottis
5 minutes post-intubation
10 minutes post-intubation
|
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
16/08/2024 |
| 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 fibreoptic intubation is considered the gold standard for the management of difficult airway It is best performed with the patient awake to maintain spontaneous ventilation Dexmedetomidine has been successful in AFOI due to its diverse actions such as it’s sedative, hypnotic, anxiolytic, analgesic, anti-sialagogue and sympatholytic properties and ability to provide anterograde amnesia and promote cardiac, respiratory and neurological stability This study can be helpful as a technique of attempting fibreoptic intubation in patients having difficult airway, less mouth opening, cervical fractures, inability to extend neck
|