| CTRI Number |
CTRI/2022/01/039224 [Registered on: 06/01/2022] Trial Registered Prospectively |
| Last Modified On: |
04/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Changes in blood pressure and cough reflex during tracheostomy tube change by using two different drugs. |
|
Scientific Title of Study
|
To compare the effect of Dexmedetomidine and Fentanyl on the attenuation of airway and pressure response during tracheostomy tube change in traumatic brain injury patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Erra Anuhya |
| Designation |
MD Anaesthesiology |
| Affiliation |
Institute of Medical Sciences ,Banaras Hindu University ,Varanasi |
| Address |
Department of Anaesthesiology, Institute of Medical Sciences , Banaras Hindu University , Varanasi , Uttar Pradesh , 221005 , India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7416863020 |
| Fax |
|
| Email |
anuhyaerra92@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yashpal Singh |
| Designation |
Professor |
| Affiliation |
IMS,BHU |
| Address |
Department of Anaesthesiology,IMS,BHU,Varansai
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9918424416 |
| Fax |
|
| Email |
dryashacin1999@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yashpal Singh |
| Designation |
Professor |
| Affiliation |
IMS,BHU |
| Address |
Department of Anaesthesiology,IMS,BHU,Varansai
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9918424416 |
| Fax |
|
| Email |
dryashacin1999@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Trauma Centre |
| Address |
Department of Anaesthesiology, Institute of Medical Sciences ,Banaras Hindu University , Varanasi ,Uttar Pradesh ,221005 ,India |
| Type of Sponsor |
Research institution 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 Erra Anuhya |
Institute of medical sciences(IMS) |
Trauma Centre ICU, Department of anaesthesiology
Varanasi
UTTAR PRADESH |
7416863020
anuhyaerra92@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee ,Faculty of Mdicine, , Institute of Medical Sciences, Banaras Hindu University, Varanasi ,India , 221005 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S069||Unspecified intracranial injury, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine |
0.5 mcg/kg diluted in 25ml normal saline , infused over 10min before procedure |
| Comparator Agent |
Fentanyl |
1 mcg/kg diluted in 25ml normal saline over 10min before procedure |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Head injury patients on tracheostomy tube.
2.Age group between 18 and 60 years. |
|
| ExclusionCriteria |
| Details |
1.Cervical spine injury.
2.Heart Rate below 60/min.
3.Arterial pressure less than 100/60 mm of Hg.
4.History of allergic reaction to the study mentioned drugs.
5.Refusal to take part in the study.
6.Patients with COPD/Asthma/Diabetes/Hypertension.
7.Patients on Neuromuscular blockers or any sedative drugs.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic parameters and cough reflex |
0,1,3,5,10,15 and 30 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| associated adverse events |
0,1,3,5,10,15 and 30 min |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
10/01/2022 |
| 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
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
After obtaining written and informed consent from the patients relative, the patients will be divided randomly using computer generated number and concealed using sequentially numbered, sealed opaque envelope technique into two equal groups(each 50 patients): Group D: Will receive Dexmedetomidine 0.5 mcg/kg diluted in 25 ml of normal saline IV over a period of 10 minutes, before the procedure. Group F:Will receive Fentanyl 1 mcg/kg diluted in 25 ml of normal saline IV over a period of 10 minutes, before the procedure. The nature and safety of the procedure will be explained, written and informed consent will be obtained. After confirming the fasting status, baseline Non Invasive Blood Pressure (NIBP), Heart Rate (HR) and Oxygen Saturation (SpO2) will be recorded. Hemodynamic variables will be measured-baseline before drug administration 5 and 10 minutes after respective drug administration. Under aseptic precautions tracheostomy tube will be changed after intravenous administration of the respective studied drugs. Hemodynamic variables will be recorded at 1,3,5,10,15 and 30 minutes after the procedure. Time taken for changing tracheostomy tube will be recorded. Grading of cough was noted as a measure of response to tracheal stimulation. Coughing after the change of tube was assessed using a 5 point scale: 1. No cough, easy breathing. 2. Slight cough (one or two), easy breathing. 3. Moderate coughing (three or four). 4. Heavy coughing, breathing hard. 5. Laryngospasm, severe coughing and hardly breathing. |