| CTRI Number |
CTRI/2023/05/052514 [Registered on: 11/05/2023] Trial Registered Prospectively |
| Last Modified On: |
10/05/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparative study between Midazolam and dexmedetomidine nebulisation in a patient posted for fiberoptic bronchoscopy |
|
Scientific Title of Study
|
Midazolam vs dexmedetomidine nebulization as adjuvant to lignocaine a comparative study 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 |
Poonam Kumari |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences,Patna |
| Address |
Room no 506, IPD Building , Department of anaesthesiology, AIIMS, Patna
Patna
BIHAR
801505
India |
| Phone |
9473199126 |
| Fax |
|
| Email |
drpoonam1981@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Poonam Kumari |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences,Patna |
| Address |
Room no 506, IPD Building , Department of anaesthesiology, AIIMS, Patna
Patna
BIHAR
801505
India |
| Phone |
9473199126 |
| Fax |
|
| Email |
drpoonam1981@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Poonam Kumari |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences,Patna |
| Address |
Room no 506, IPD Building , Department of anaesthesiology, AIIMS, Patna
Patna
BIHAR
801505
India |
| Phone |
9473199126 |
| Fax |
|
| Email |
drpoonam1981@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS Patna |
| Address |
Department of anaesthesiology ,AIIMS Patna |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| AIIMS Patna |
Department of anaesthesiology ,AIIMS Patna |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Poonam Kumari |
AIIMS Patna |
3rd floor IPD Building , Department of Pulmonary Medicine ,AIIMS Patna
Patna
BIHAR |
9473199126
drpoonam1981@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC AIIMS Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J709||Respiratory conditions due to unspecified external agent, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nebulized with mixture of 4% lignocaine 4 ml and midazolam 0.2mg/kg by using ultrasonic nebulizer followed by FFB |
Group I : patient will be nebulized with mixture of 4% lignocaine 4 ml and midazolam 0.2mg/kg by using ultrasonic nebulizer followed by FFB
assessment over 30 min |
| Comparator Agent |
Nebulized with mixture of 4% lignocaine 4ml and dexmedetomidine 1µg/kg by using ultrasonic nebulizer followed by FFB |
Group II:Patient will be nebulized with mixture of 4% lignocaine 4ml and dexmedetomidine 1µg/kg by using ultrasonic nebulizer followed by FFB.
assessment over 30 min |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age 18 to 60 years
ASA I/II
Scheduled for elective bronchoscopy procedure(Diagnostic & therapeutic)
|
|
| ExclusionCriteria |
| Details |
Unconscious and uncooperative patients
Intubated patient on ventilator,
patient need general anaesthesia
Patient on oxygen
Asthmatics
Epileptics
Coagulation abnormalities
|
|
|
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 determine mean cough score |
30 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Gag reflex
patient comfort
post procedure patient satisfaction
Ramsay sedation score (RSS)
signs of lignocaine toxicity
|
1 hour |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/06/2023 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Flexible fiberoptic bronchoscopy (FFB) technology is challenging one. Most FFBs are assisted by sedation and local anesthesia.AIM:To compare the effect of midazolam and dexmedetomidine nebulization as an adjuvant to lignocaine before awake fiber optic bronchoscopy: in terms of cough/gag reflex and patient comfort/satisfaction.Primary objective mean cough score |