| CTRI Number |
CTRI/2023/11/059704 [Registered on: 09/11/2023] Trial Registered Prospectively |
| Last Modified On: |
07/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between intravenous Midazolam and intravenous Fentany in flexible bronchosopy. |
|
Scientific Title of Study
|
Comparison between intravenous Midazolam (0.035mg/kg) and intravenous Fentanyl (50mcg) in flexible bronchosopy- A prospective, randomized, double blinded study |
| 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 Manish R Shetty |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College and Hospital, MAHE, Manipal |
| Address |
Department of Respiratory Medicine, Kasturba Hospital, KMC Manipal, MAHE, India
Udupi
KARNATAKA
576104
India |
| Phone |
9483870029 |
| Fax |
|
| Email |
manishr213@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rahul magazine |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College and Hospital, MAHE, Manipal |
| Address |
Department of Respiratory Medicine, Kasturba Hospital, KMC Manipal, MAHE, India
Udupi
KARNATAKA
576104
India |
| Phone |
9901727204 |
| Fax |
|
| Email |
rahul.magazine@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manish R Shetty |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College and Hospital, MAHE, Manipal |
| Address |
Department of Respiratory Medicine, Kasturba Hospital, KMC Manipal, MAHE, India
Udupi
KARNATAKA
576104
India |
| Phone |
9483870029 |
| Fax |
|
| Email |
manishr213@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Respiratory Medicine, Kasturba Hospital, KMC Manipal, MAHE, Karnataka, India PINCODE: 576104 |
|
|
Primary Sponsor
|
| Name |
Department of Respiratory Medicine, KMC Manipal |
| Address |
Department Of Respiratory Medicine, KMC Manipal, Udupi- 576104 |
| Type of Sponsor |
Other [Deemed Medical College And Hospital] |
|
|
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 Manish R Shetty |
KMC MANIPAL |
Department Of Respiratory Medicine, KMC Manipal, Udupi- 576104
Udupi
KARNATAKA |
9483870029
manishr213@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 |
| Comparator Agent |
Either Intravenous Midazolam (0.035mg/kg) or Intravenous fentanyl (50mcg) on Patient response to flexible bronchoscopy. |
After the inclusion criteria for the patients undergoing bronchoscopy are met, patients are alloted to either of the two groups,Group M will recieve inj Midazolam 0.035mg/kg intravenously stat and Group F will recieve inj Fentanyl (50mcg) intravenously stat as per the randomization chart generated via Microsoft Excel.Composite scoring is compared between the two groups undergoing bronchoscopy procedure. |
| Intervention |
Either Intravenous Midazolam (0.035mg/kg) or Intravenous fentanyl (50mcg) on Patient response to flexible bronchoscopy |
After the inclusion criteria for the patients undergoing bronchoscopy are met, patients are alloted to either of the two groups,Group M will recieve inj. Midazolam (0.035mg/kg) intravenously stat and Group F will recieve inj. Fentanyl (50mcg) intravenously stat as per the randomization chart generated via Microsoft Excel.Composite scoring is compared between the two groups undergoing bronchoscopy procedure. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All patients in the age group 18 to 70 years, weighing 50-85kg and undergoing flexible bronchoscopy in the Department of Respiratory Medicine |
|
| ExclusionCriteria |
| Details |
Patients with known or suspected allergy to Midazolam and Fentanyl, patients with Renal impairment, Hepatic impairment, seizure disorder, Psychiatric illness, hemodynamic instability including cardiac failure, second or third degree heart block, heart rate less than 50/ minute, COPD patients with Forced Expiratory Volume less than 50%, Pregnancy and Lactation, Oxygen saturation less than 90%, Platelet count less than 50, 000/ cubic milli meters |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Composite score during the bronchoscopy procedure |
at the level of nasopharynx for 1 minute and at the time of passage through trachea for 1 minute |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Ease of Performing bronchoscopy
2. pain and distress measured by Numerical Rating Scale
3. Visual Analogue Scale for Cough
4. Modified ramsay Sedation Score
5. Post procedure patient response after 24 hours |
1. Ease of Performing bronchoscopy
2. pain and distress measured by Numerical Rating Scale
3. Visual Analogue Scale for Cough
4. Modified ramsay Sedation Score
5. Post procedure patient response after 24 hours |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
24/11/2023 |
| 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="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
|
To study the effects of intravenous Midazolam (0.035mg/kg) and intravenous Fentanyl (50mcg) on patient response to flexible bronchoscopy. To assess and compare the patient response and comfort in flexible bronchoscopy done under intravenous Midazolam and intravenous Fentanyl. To assess and compare the attenuation of pressor response in flexible bronchoscopy done under intravenous Midazolam and intravenous Fentanyl. |