| CTRI Number |
CTRI/2020/02/023254 [Registered on: 11/02/2020] Trial Registered Prospectively |
| Last Modified On: |
30/05/2023 |
| 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
|
Comparison between two sedatives used for anaesthesia during bronchoscopy procedure |
|
Scientific Title of Study
|
Comparison between intravenous Midazolam(0.035mg/Kg)-Fentanyl
(25mcg)combination and intravenous Dexmedetomidine(0.75mcg/kg) in flexible bronchoscopy-
A prospective, randomized, double blinded study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vrinda Mariya Elenjickal |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Dept of Respiratory Medicine, Kasturba Medical College, Manipal 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9986822148 |
| Fax |
|
| Email |
vrinda46@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vrinda Mariya Elenjickal |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Dept of Respiratory Medicine, Kasturba Medical College, Manipal 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9986822148 |
| Fax |
|
| Email |
vrinda46@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vrinda Mariya Elenjickal |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Dept of Respiratory Medicine, Kasturba Medical College, Manipal 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9986822148 |
| Fax |
|
| Email |
vrinda46@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Manipal |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College Manipal |
| Address |
Dept of Respiratory Medicine, Kasturba Medical College, Manipal 576104 |
| 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 Rahul Magazine |
Kasturba Hospital |
Bronchoscopy room, Department of Respiratory Medicine, Kasturba Medical College, Manipal
Udupi
KARNATAKA |
7019679045
rahulmagazine@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical college and Kasturba Hospital Institutional Ethics Committee |
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 |
Intravenous Dexmedetomidine(0.75mcg/kg).
|
Intravenous Dexmedetomidine (0.75mcg/kg)in flexible bronchoscopy. duration of therapy will be only so long as to give the adequate sedation during the procedure of bronchoscopy which will be around 10 minutes. |
| Comparator Agent |
Intravenous Midazolam(0.035mg/Kg)-Fentanyl (25mcg)combination |
Intravenous Midazolam(0.035mg/Kg)-Fentanyl (25mcg)combination in flexible bronchoscopy. duration of therapy will be only so long as to give the adequate sedation during the procedure of bronchoscopy which will be around 10 minutes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All patients in the age group 18 to 65 years undergoing flexible bronchoscopy in the Department of Respiratory Medicine. |
|
| ExclusionCriteria |
| Details |
1. Patients with known or suspected allergy to Midazolam or Dexmedetomidine.
2. Patients with renal impairment
3. Patients with hepatic impairment
4. Patients with seizure disorder.
5. COPD patients with Forced Expiratory Volume (FEV1 )< 50%.
6. Patients with psychiatric illness.
7. Haemodynamic instability including cardiac failure.
8. Second or third degree heart block/ Heart rate <50/min
9. Patients weighing more than 70kg.
10. Pregnancy and lactation.
11. Hypovolemia.
12. Oxygen Saturation < 90%
|
|
|
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 |
| To study the effects of intravenous Midazolam(0.035mg/kg)-Fentanyl(25mcg) combination and intravenous Dexmedetomidine (0.75mcg/kg) on patient response to flexible bronchoscopy. |
before the administration of study drugs, at the start of flexible bronchoscopy, 5 minutes after the start of bronchoscopy, 10 minutes after the start of bronchoscopy and 10 minutes after the completion of bronchoscopy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Duration of bronchoscopy procedure.
2. Number of doses of rescue medication given.
3. Haemodynamic parameters
4. Total dose of Lignocaine used
5. Oxygen saturation
6. Diagnostic procedures done during bronchoscopy |
At 0 minutes, 2 minutes into the procedure, at the end of precedure, 5 minutes after the procedure |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
Final Enrollment numbers achieved (Total)= "62"
Final Enrollment numbers achieved (India)="62" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/02/2020 |
| Date of Study Completion (India) |
14/04/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Patient comfort during an invasive procedure like flexible bronchoscopy is of great importance. use of appropriate sedative in correct dosage will provide ease of bronchoscopy. there are only limited studies comparing the effects of of midazolam-fentanyl combination and dexmedetomidine in flexible bronchoscopy. ultimate goal of this study is to find a suitable drug at a dose that does not produce any serious adverse effects so that pulmonologists can safely perform bronchoscopy with ease. |