| CTRI Number |
CTRI/2025/10/096207 [Registered on: 21/10/2025] Trial Registered Prospectively |
| Last Modified On: |
17/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing magnesium sulfate and lidocaine nebulization for reducing stress responses during laryngoscopy and intubation |
|
Scientific Title of Study
|
Comparison of magnesium sulfate and lidocaine nebulization on attenuation of hemodynamic responses to laryngoscopy and endotracheal intubation |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SAURAV KUMAR |
| Designation |
PG1 |
| Affiliation |
VMMC & Safdarjung hospital |
| Address |
Vmmc & Safdarjung hospital ,ansari nagar , south west delhi
South West
DELHI
110029
India |
| Phone |
9123435200 |
| Fax |
|
| Email |
sauravkryadhuvanshi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SAURAV KUMAR |
| Designation |
PG1 |
| Affiliation |
VMMC & Safdarjung hospital |
| Address |
Vmmc & Safdarjung hospital ,ansari nagar , south west delhi
South West
DELHI
110029
India |
| Phone |
9123435200 |
| Fax |
|
| Email |
sauravkryadhuvanshi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SAURAV KUMAR |
| Designation |
PG1 |
| Affiliation |
VMMC & Safdarjung hospital |
| Address |
Vmmc & Safdarjung hospital ,ansari nagar , south west delhi
South West
DELHI
110029
India |
| Phone |
9123435200 |
| Fax |
|
| Email |
sauravkryadhuvanshi@gmail.com |
|
|
Source of Monetary or Material Support
|
| VMMC & SAFDARJUNG HOSPITAL ,NEW DELHI |
|
|
Primary Sponsor
|
| Name |
Dr SAURAV KUMAR |
| Address |
Vmmc & Safdarjung hospital ,ansari nagar , south west delhi |
| 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 saurav kumar |
vmmc& safdarjung hospital |
Ansari nagar east , near AIIMS metro station , south west delhi , 110029
South West
DELHI |
9123435200
sauravkryadhuvanshi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee vmmc and safdarjung hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H65-H75||Diseases of middle ear and mastoid, (2) ICD-10 Condition: M80-M85||Disorders of bone density and structure, (3) ICD-10 Condition: K80-K87||Disorders of gallbladder, biliary tract and pancreas, (4) ICD-10 Condition: K40-K46||Hernia, (5) ICD-10 Condition: N25-N29||Other disorders of kidney and ureter, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Comparison of magnesium sulfate and lidocaine nebulization on attenuation of hemodynamic responses to laryngoscopy and endotracheal intubation |
After ethical approval and consent, 106 patients (53 per group: Group L for Lidocaine, Group M for MgSO4) undergo pre-anaesthetic checkups, baseline parameters (NIBP, HR, SpO2, RR) are monitored, and groups receive specific nebulizations (Lidocaine 2 mg/kg or MgSO4 40 mg/kg over 15 minutes). Adverse effects halt the procedure, and a blinded anaesthesiologist records hemodynamic data during laryngoscopy and endotracheal intubation at a specific duration post-procedure |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
65.00 Day(s) |
| Gender |
Both |
| Details |
Patients aged between 18 and 6 5 years, American Society o f Anesthesiologists
physical status I and II, scheduled for elective surgeries under general
anaesthesia requiring endotracheal intubation will be included in this study. |
|
| ExclusionCriteria |
| Details |
pregnancy and lactation, Hypersensitivity to two study drugs, and an anticipated difficult airway
, History of reactive airway diseases
hypertension, Patients with cardiovascular dysfunction & arrhythmias, Patients with raised ICP, IOP, any neuromuscular disorder, Patients who received epidural or spinal before general anaesthesia. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Nebulised MgSO4 tends to show superior or comparable attenuation of hemodynamic responses compared to nebulised lidocaine. |
Nebulised MgSO4 tends to show superior or comparable attenuation of hemodynamic responses compared to nebulised lidocaine. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="106"
Sample Size from India="106"
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)
|
17/11/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Data are available indefinitely at (Link to be included sauravkryadhuvanshi@gmail.com).
- For how long will this data be available start date provided 30-11-2026 and end date provided 30-11-2050?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This randomised controlled trial will compare the effect of nebulisation of MgSO4 and lidocaine on attenuating hemodynamic response during laryngoscopy and endotracheal intubation in ASA grade 1 and 2 patients undergoing elective surgery. A total of 106 patients will be selected based on inclusion and exclusion criteria. Vital parameters, such as HR, BP, and SPO2, will be measured at various time points, like baseline, post-nebulisation, post-induction, 1, 2, 5, and 10 minutes post-laryngoscopy and intubation. The efficacy of both drugs in attenuating the hemodynamic response will be compared. |