| CTRI Number |
CTRI/2023/12/060744 [Registered on: 26/12/2023] Trial Registered Prospectively |
| Last Modified On: |
22/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
A study to evaluate the effectiveness of Dexmedetomidine vs Lignocaine 4% nebulization in decreasing the stress response of laryngoscopy |
|
Scientific Title of Study
|
Effectiveness of Dexmedetomidine vs Lignocaine 4% nebulization to attenuate haemodynamic response during laryngoscopy |
| 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 Farhan Moosani |
| Designation |
Resident Doctor |
| Affiliation |
Pandit Deendayal Upadhyay Medical College |
| Address |
Department of Anaesthesiology, 3rd floor, OPD Building, P.D.U Govt Medical College and Civil Hospital, Rajkot
Room No 602 New Pg Hostel, Jamnagar Road, Near Civil hospital, Rajkot
Rajkot
GUJARAT
360001
India |
| Phone |
7434002060 |
| Fax |
|
| Email |
drfarhanmoosani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vandana Parmar |
| Designation |
Professor and Head of the Department |
| Affiliation |
Pandit Deendayal Upadhyay Medical College and Civil Hospital, Rajkot |
| Address |
Department of Anaesthesiology, 3rd floor, OPD Building, P.D.U Govt Medical College and Civil Hospital, Rajkot
Rajkot
GUJARAT
360001
India |
| Phone |
9898090220 |
| Fax |
|
| Email |
drvandanapithadia@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Farhan Moosani |
| Designation |
Resident Doctor |
| Affiliation |
Pandit Deendayal Upadhyay Medical College |
| Address |
Department of Anaesthesiology, 3rd floor, OPD Building, P.D.U Govt Medical College and Civil Hospital, Rajkot
Room No 602 New Pg Hostel, Jamnagar Road, Near Civil hospital, Rajkot
Rajkot
GUJARAT
360001
India |
| Phone |
7434002060 |
| Fax |
|
| Email |
drfarhanmoosani@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pandit Deendayal Upadhyay Medical College (PDU) Civil Hospital Campus, Jamnagar Road, Rajkot – 360001 |
|
|
Primary Sponsor
|
| Name |
Dr Farhan Moosani |
| Address |
3rd Floor, OPD Building, Pandit Deendayal Upadhyay Medical College (PDU) and Civil Hospital Campus |
| 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 Farhan Moosani |
Pandit Deendayal Upadhyay Medical College (PDU) and Civil Hospital Campus |
3rd floor, OPD Building, Anesthesia Department Room
Rajkot
GUJARAT |
7434002060
drfarhanmoosani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of P.D.U Govt. Medical College, Rajkot |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H619||Disorder of external ear, unspecified, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine |
Dexmedetomidine is a potent, highly selective α-2 adrenoceptor agonist, with sedative, analgesic, anxiolytic, sympatholytic, and opioid-sparing properties.
The patients will be nebulized with 2 micro gm/kg Dexmedetomidine with normal saline (making total volume, 4 ml), 10 min. prior to induction. |
| Comparator Agent |
Lignocaine 4% topical solution |
It contains Lignocaine which belongs to the group of medicines called Local Anesthetics.
The patients will be nebulized with Inj. Lignocaine 4% 3 mg/kg (making total volume, 4 ml) for 10 min. prior to induction. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA Grade 1 and 2
|
|
| ExclusionCriteria |
| Details |
Emergency operations
Uncontrolled systemic disease
Obese individuals
Anticipated difficult intubation |
|
|
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 evaluate the Effectiveness of Dexmedetomidine and Lignocaine 4% nebulization in attenuating hemodynamic response during laryngoscopy. Laryngoscopy and Intubation responses result in increased circulatory catecholamines, heart rate (HR), blood pressure, myocardial oxygen demand, and dysrhythmias. The rise in HR and blood pressure is usually transient, variable, and unpredictable. |
To evaluate hemodynamic status (Pulse rate, blood pressure, MBP, Spo2), Ramsay sedation score in time points of 2 mins, 5 mins, 10 mins, 15 mins and 20 mins after intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare intra-operative hemodynamic parameters (HR, SBP, DBP, MAP) in both groups.
2. To determine the level of sedation
3. To evaluate any intra or post-operative adverse effects of the drug
|
To evaluate hemodynamic status, Ramsay sedation score in time points of 2 mins, 5 mins, 10 mins, 15 mins and 20 mins after intubation |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
02/01/2024 |
| 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="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
|
After obtaining the approval from Institutional Ethics Committee and written informed consent; a prospective, randomized, double blind, controlled study will be recruiting 120 adult patients posted for elective surgery under GA. The cases will be randomly allocated with sealed envelope with computer generated numbers in two groups, in which traditional protocol will be kept as control. They will be randomized into two groups: Group D and Group L. |