| CTRI Number |
CTRI/2025/03/081809 [Registered on: 06/03/2025] Trial Registered Prospectively |
| Last Modified On: |
20/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
In patients undergoing elective surgery under general anesthesia, a research comparing the effects of Intravenous dexmedetomidine, nebulized lidocaine, and a combination of the two on hemodynamic response for intubation |
|
Scientific Title of Study
|
A Randomized study to compare the effect of Intravenous Dexmedetomidine versus Nebulized Lidocaine versus combination of Intravenous Dexmedetomidine with Nebulized Lidocaine on hemodynamic response for intubation in patients undergoing elective surgery under general anaesthesia
|
| 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 Mamta Khandelwal |
| Designation |
Senior Professor |
| Affiliation |
Sawai Man Singh Medical College, Jaipur |
| Address |
Department of Anaesthesiology,
Second floor, Dhanvantri building, JLN Marg
Jaipur
RAJASTHAN
302001
India |
| Phone |
9929338174 |
| Fax |
|
| Email |
drmamtakhandelwal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mamta Khandelwal |
| Designation |
Senior Professor |
| Affiliation |
Sawai Man Singh Medical College, Jaipur |
| Address |
Department of Anaesthesiology,
Second floor, Dhanvantri building, JLN Marg
RAJASTHAN
302001
India |
| Phone |
9929338174 |
| Fax |
|
| Email |
drmamtakhandelwal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harshawarthan P |
| Designation |
Junior Resident |
| Affiliation |
Sawai Man Singh Medical College, Jaipur |
| Address |
Department of Anaesthesiology,
Second floor, Dhanvantri building, JLN Marg
Jaipur
RAJASTHAN
302001
India |
| Phone |
9095559772 |
| Fax |
|
| Email |
harshawarthanharsh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, SMS Medical College, Jaipur, Rajasthan, India - 302004. |
|
|
Primary Sponsor
|
| Name |
Sawai Man Singh Medical College and Hospital |
| Address |
Department of Anaesthesiology,
Second floor, Dhanvantri building, JLN Marg, Jaipur, Rajasthan, India - 302004 |
| Type of Sponsor |
Government 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 Harshawarthan P |
Sawai Man Singh Medical College and Hospital |
General Surgery OT Complex,
Second floor, Dhanvantri building
Jaipur
RAJASTHAN |
9095559772
harshawarthanharsh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of the Ethics Committee, SMS Medical College and Attached Hospitals, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R688||Other general symptoms and signs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
comparison of the effect of IV Dexmedetomidine vs Nebulized Lidocaine vs combination of IV Dexmedetomidine with Nebulized Lidocaine on hemodynamic response for intubation in patients undergoing elective surgery under general anaesthesia |
Determination of the change in Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure, Mean Arterial Pressure and Rate Pressure Product within three groups at 1, 3, 5, 7 and 10 min post intubation and also to determine the side effects like bradycardia, hypotension, bitter taste, dysphonia and oropharyngeal numbness within three groups.
|
| Intervention |
GROUP A: Patients will receive Intravenous Dexmedetomidine (1mcg/kg) and nebulized lidocaine 4%(2 mg/kg) |
Group A will receive IV Dexmedetomidine 1mcg/kg infusion diluted in NS (total volume 25ml) over 10mins before induction of anaesthesia along with nebulization via a face mask with lidocaine 4% (2mg/kg) diluted with NS (total volume 5ml) with oxygen flow rate of 8L/min in the OR. |
| Intervention |
GROUP B: Patients will receive Intravenous Dexmedetomidine (1 mcg/kg) |
Group B will receive IV Dexmedetomidine 1mcg/kg infusion diluted in NS (total volume 25ml) over 10mins before induction of anaesthesia along with (5ml) NS nebulization via a face mask with oxygen flow rate of 8L/min in the OR. |
| Intervention |
GROUP C: Patients will receive nebulized lidocaine 4% (2 mg/kg) |
Group C will receive nebulization via a face mask with lidocaine 4% (2mg/kg) diluted with NS (total volume 5ml) with oxygen flow rate of 8L/min in the OR and 25 ml NS infusion over 10 mins before induction of anaesthesia. |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient undergoing elective surgery under general anaesthesia requiring endotracheal intubation
2.Patients consenting to participate
3.Adult patients
4.Patients belonging to American Society of Anesthesiologists (ASA) grade I and II
|
|
| ExclusionCriteria |
| Details |
1.Patient should not be a part of other study
2.Non co-operative patient
3.Patients with difficult airway
4.Patients with cardiorespiratory comorbidity
5.Patients with smoking history
6.Patients on antihypertensive medication |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the change in Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure, Mean Arterial Pressure and Rate Pressure Product within three groups |
To determine the change in Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure, Mean Arterial Pressure and Rate Pressure Product within three groups at 1, 3, 5, 7 and 10 minutes post intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the side effects. |
After completion of surgery the side effects like bradycardia, hypotension, bitter taste, dysphonia and oropharyngeal numbness within three. |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
12/05/2025 |
| 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="0"
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
|
Study Universe - Patients
undergoing elective surgery under general anaesthesia requiring endotracheal
intubation
Study Population - Patients undergoing
elective surgery under general anaesthesia requiring endotracheal intubation coming
to SMS hospital
Screening, PAC written
informed consent
Sample
population (n=90)
Randomization
will be done using computer-generated random number table
.
Group A(n=30): Patient will receive IV Group B(n=30): Patient
will receive Group C(n=30):
Patient
Dexmedetomidine and lidocaine IV Dexmedetomidine will be nebulized with
nebulization
lidocaine
Haemodynamic variables Haemodynamic
variables Haemodynamic variables
(HR,SBP,DBP,MAP) (HR,SBP,DBP,MAP) (HR,SBP,DBP,MAP)
Side effects Side effects Side effects
Statistical Analysis
Inference |