| CTRI Number |
CTRI/2025/08/093079 [Registered on: 14/08/2025] Trial Registered Prospectively |
| Last Modified On: |
14/08/2025 |
| 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
|
comparing 3 drugs delivered via mucosal atomiser device for painless bronchoscopy in patients with lung infection |
|
Scientific Title of Study
|
Randomised comparative study between atomised intranasal dexmedetomidine ,
lignocaine and ketamine as premedication for flexible fibreoptic bronchoscopy |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prerna Bhola |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
ESIC MEDICAL COLLEGE |
| Address |
ROOM-3021, OT COMPLEX, ESIC MEDICAL COLLEGE, SANATHNAGAR, HYDERABAD
SANATHNAGAR, HYDERABAD, TELANGANA- 500038
Hyderabad
TELANGANA
500038
India |
| Phone |
09440152961 |
| Fax |
|
| Email |
dr.prernabhola@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ananya Nanda |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
ESIC MEDICAL COLLEGE |
| Address |
ROOM-3021, OT COMPLEX, ESIC MEDICAL COLLEGE,
SANATHNAGAR, HYDERABAD
TELANGANA
500038
India |
| Phone |
08179654082 |
| Fax |
|
| Email |
niraananya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prerna Bhola |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
ESIC MEDICAL COLLEGE |
| Address |
ROOM-3021, OT COMPLEX, ESIC MEDICAL COLLEGE, SANATHNAGAR, HYDERABAD
SANATHNAGAR, HYDERABAD, TELANGANA- 500038
Hyderabad
TELANGANA
500038
India |
| Phone |
9440152961 |
| Fax |
|
| Email |
dr.prernabhola@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ESIC MEDICAL COLLEGE AND HOSPITAL |
| Address |
ESIC Medical College and Hospital, Sanathnagar, Hyderabad, TELANGANA - 500038 |
| 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 Ananya nanda |
ESIC Medical College and Hospital |
3rd floor, OT complex, ESIC Medical College Hospital, sanathnagar, hyderabad
Hyderabad
TELANGANA |
08179654082
niraananya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| instituitional ethics committee, ESIC Medical College and Hospital and superspeciality hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J22||Unspecified acute lower respiratory infection, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomedine |
2 mcg/kg intranasal dexmedetomedine will be given through atomizer on deep inhalation, 30 minutes prior to procedure |
| Intervention |
Ketamine |
2mg/kg intranasal ketamine will be given through atomizer on deep inhalation, 30 minutes prior to procedure |
| Intervention |
Lignocaine |
1.5 mg/kg intranasal lignocaine will be given through atomizer on deep inhalation, 30 minutes prior to procedure |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
ASA I & II patients, age older than 18 years, BMI less than 30 kg/cm2 |
|
| ExclusionCriteria |
| Details |
ASA III & IV patients, history of bronchial asthma, history of allergy to the study drugs |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| patient cough score |
baseline,immediately after passage of bronchoscope through vocal cords, at 5 and 10 minutes during the bronchoscopy procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| patient satisfaction score |
10 minutes after end of procedure |
| ramsay sedation score |
prior to procedure, 10 minutes after end of proceure |
| endoscopists satisfaction score |
after end of procedure |
| rescue lignocaine required |
during procedure |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/09/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
the study aims to compare the effectiveness of atomised intranasal demedetomedine, lignocaine and ketamine as premedication for flexible fibreoptic bronchoscopy. Primary objective is to evaluate the incidence of moderate to severe cough during the procedure. Secondary objective is to compare the patient satisfaction score, endoscopist satisfaction score, ramsay sedation score and if any rescue lignocaine required. ASA I & II patients of more than 18 years age with BMI less than 30 kg/m2 will be included and patients with history of bronchial asthma or allergy to the study drugs will be excluded. 60 patients will be randomly divided into 3 groups of 20 each. atomised ketamine (2mg/kg), atomised dexmedetomidine (2 mcg/kg) and atomised lignocaine (1.5 mg/kg) will be given as premedication 30 inutes prior to the procedure and the above mentioned objectives will be assessed. P values less than 0.05 will be considered significant. |