| CTRI Number |
CTRI/2018/11/016429 [Registered on: 27/11/2018] Trial Registered Prospectively |
| Last Modified On: |
26/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Study to compare two drugs: fentanyl and dexmedetomidine used to numb the wind pipe to do endoscopy. |
|
Scientific Title of Study
|
Comparison between fentanyl and dexmedetomidine nebulization as adjuvant to lignocaine during awake flexible fiberoptic bronchoscopy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Poonam Kumari |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS,Patna |
| Address |
Department of Anaesthesia, Faculty Room, 3rd Floor, Ayush PMR Building, AIIMS,Patna
Patna
BIHAR
801507
India |
| Phone |
|
| Fax |
|
| Email |
drpoonam1981@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Poonam Kumari |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS,Patna |
| Address |
Department of Anaesthesia, Faculty Room, 3rd Floor, Ayush PMR Building, AIIMS,Patna
Patna
BIHAR
801507
India |
| Phone |
|
| Fax |
|
| Email |
drpoonam1981@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Poonam Kumari |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS,Patna |
| Address |
Department of Anaesthesia, Faculty Room, 3rd Floor, Ayush PMR Building, AIIMS,Patna
Patna
BIHAR
801507
India |
| Phone |
|
| Fax |
|
| Email |
drpoonam1981@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMSPatna |
| Address |
Phulwarisharif, Patna, Bihar |
| Type of Sponsor |
Government 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 Poonam Kumari |
All India Institute of Medical Sciences, Patna |
OT complex, Recovery area, PACU, HDU, ICU of All India Institute of Medical Sciences, Patna
Patna BIHAR
Patna
BIHAR |
916122451070
drpoonam1981@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, AIIMS,Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J00-J99||Diseases of the respiratory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine 1µg/kg to lignocaine 4 ml 4% |
dose: Dexmedetomidine 1µg/kg to 4 ml of 4% lignocaine
route: nebulisation
frequency: once
duration: 20 minutes |
| Comparator Agent |
Fentanyl 2µg/kg added to 4 ml of 4% lignocaine |
dose:Fentanyl 2µg/kg added to 4 ml of 4% lignocaine
route: nebulisation
frequency: once
duration: 20 minutes
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA I/II patients Scheduled for elective bronchoscopy diagnostic procedure
|
|
| ExclusionCriteria |
| Details |
1. Unconscious and uncooperative patients
2. Intubated patient on ventilator, patient need general anaesthesia,
3. Patient on oxygen
4. Allergic to LA, fentanyl, dexmedetomidine
5. Asthmatics
6. Epileptics
7. Coagulation abnormalities
8. Haemodynamic instability, bradyarrhythmias
|
|
|
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 |
1.no. of cough reflex
2. no of additional lignocaine sprays required |
1. 60 minutes
2. 60 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. patient satisfaction score
2. additional sedative doses
3. heart rate and mean arterial pressure |
1. after 2 hours
2. 60 minutes
3. 60 minutes |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
29/11/2018 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
2. Bartfield JM, Flint RD, McErlean M, Broderick J. Nebulized fentanyl for relief of abdominal pain. AcadEmerg Med. 2003; 10:215–8.
3. Worsley MH, MacLeod AD, Brodie MJ, Asbury AJ, Clark C. Inhaled fentanyl as a method of analgesia. Anaesthesia. 1990; 45:449–51.
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Awake fiberoptic aided diagnostic procedures requires an anaesthetised airway to facilitate smooth introduction of the scope and prevent cough or gag reflex. Various techniques include nebulisation of the airway using local anaesthetic. Lately fentanyl and dexmedetomidine have also been used through nebulisation. Hence we aimed to compare both of these drugs as an adjuvant to lignocaine and see whether they facilitate the process of bronchoscopy. |