| CTRI Number |
CTRI/2024/07/071191 [Registered on: 24/07/2024] Trial Registered Prospectively |
| Last Modified On: |
22/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of inhaled Dexmedetomidine ( this is a drug used to manage pain and sedation in the icu and operating theatre) and Lignocaine (this is a drug used to prevent pain) on blood pressure, heart rate, oxygen saturation during intubation.
|
|
Scientific Title of Study
|
Comparative evaluation of nebulised Dexmedetomidine and Lignocaine on haemodynamic stress response to laryngoscope and intubation - A prospective, randomized clinical 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 Tridha Ghosh |
| Designation |
Post Graduation Student |
| Affiliation |
Gajra Raja Medical College, Gwalior, MadhyaPradesh |
| Address |
Jaya Arogya Hospital,Campus, Lashkar, Gwalior. Block C- 7th floor, Anaesthesia Department. Room no.701.
Gwalior
MADHYA PRADESH
474009
India |
| Phone |
9903377851 |
| Fax |
|
| Email |
tridhaghosh@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jitendra Agrawal |
| Designation |
Professor |
| Affiliation |
Gajra Raja Medical College, Gwalior,Madhya Pradesh |
| Address |
Jaya Arogya Hospital, Campus,Lashkar,Gwalior, Department- Anaesthesia, block C, 7th floor, Room no. 702
Gwalior
MADHYA PRADESH
474009
India |
| Phone |
9300009942 |
| Fax |
|
| Email |
drjagrawal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jitendra Agrawal |
| Designation |
Professor |
| Affiliation |
Gajra Raja Medical College, Gwalior,Madhya Pradesh |
| Address |
Jaya Arogya Hospital, Campus,Lashkar,Gwalior, department of Anaesthesia, 7th floor, Block C , Room no. 702
Gwalior
MADHYA PRADESH
474009
India |
| Phone |
9300009942 |
| Fax |
|
| Email |
drjagrawal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gajra Raja Medical College, Veer Savakar Marg, Gwalior, Madhya Pradesh. Pincode-474009 |
|
|
Primary Sponsor
|
| Name |
Dr Tridha Ghosh |
| Address |
Jaya Arogya Hospital Campus, Lashkar, Gwalior, Madhya Pradesh 474009 |
| Type of Sponsor |
Other [Self] |
|
|
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 Tridha Ghosh |
Jaya Arogya Hospital |
Anaesthesiology Department,Block C , 7th floor, OT complex, Room 7A, Lashkar,Gwalior, Madhya Pradesh 474009
Gwalior
MADHYA PRADESH |
9903377851
tridhaghosh@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) GAJRA RAJA MEDICAL COLLEGE, GWALIOR, M.P |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nebulized Dexmedetomidine |
Patient Will be receiving nebulized Dexmedetomidine 1 microgram per kg mixed with saline to a total volume of 5ml |
| Comparator Agent |
Nebulized Lignocaine
|
Patient Will be receiving nebulized Lignocaine 4mg/kg with a nebuliser face mask and a continuous flow of 100 percent oxygen at 6L/min for 10mins before induction of anaesthesia
|
| Comparator Agent |
Normal Saline |
Patient Will be receiving 5 ml normal saline with a nebu.izer face mask with a continuous flow of 100% oxygen at 6l/ min for 10 mins before intubation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patient giving consent to participate in study
2) Age between 18-60yrs
3) American Society of Anaesthesiologist Grade 1 & 2 |
|
| ExclusionCriteria |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Dexmedetomidine (1microgram/kg) serves as a very useful anaesthesia adjuvant to control haemodynamic stress response to laryngoscope and intubation without any significant adverse effects.
2) Efficacy of nebulized dexmedetomidine in attenuation of the haemodynamic stress response compared to nebulized Lignocaine will be significantly higer in ASA-1 and 2 Patients with respect to HR, SBP, DBP and MAP.
|
These outcomes are based on observations made after giving nebulized drugs 10 minutes before intubation to 90th minutes intraoperatively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nebulized Lignocaine also attenuated the haemodynamic stress response during intubation and laryngoscopy compared to normal saline. |
These outcomes are based on observations made after giving nebulized drugs 10 minutes before intubation to 90th minutes intraoperatively. |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
02/08/2024 |
| 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="8"
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
|
The Study ’ Comparative evaluation of nebulized Dexmedetomidine and Lignocaine on haemodynamic stress response to laryngoscopy and intubation-A prospective, randomized clinical study.’ Will be done in Gajra Raja Medical College, Gwalior MP on sample size of 60 Patients for the time period of 8 months after fulfilling the eligibility criteria will be chosen by simple randomization.Patients will be subsequently randomized into 3 groups by closed enveloped technique. Group D- Patient Will be receiving nebulized Dexmedetomidine 1mjcrogram/kg.
Group L- will be receiving nebulized Lignocaine 4mg/kg. Group C- will be receiving normal saline 5ml. The Patient Will be kept under observation after intubation for noting the vital parameters
like heart rate, blood pressure ( Systolic SBP and Diastolic DBP) , mean arterial pressure, pulse oximetry (spo2) at the following time points: baseline,after nebulization,post larygoscopy/intubation at 1,5,10,20,30,40,50,60 and 90mins. After the study end, results will be obtained. Primary aim of this study is to evaluate the role of nebulized dexmedetomidine as a premedication in attenuation the stress response to larygoscopy and intubation and to compare it with nebulized Lignocaine.
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