| CTRI Number |
CTRI/2025/09/095174 [Registered on: 22/09/2025] Trial Registered Prospectively |
| Last Modified On: |
22/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Pre surgery nebulisation for response to intubation between magnesium Sulphate and dexmedetomidine |
|
Scientific Title of Study
|
Comparison of Preoperative Nebulisation with Magnesium Sulphate And Dexmedetomidine for Hemodynamic Response 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 |
DrVenkatesh Soundarya |
| Designation |
Junior Resident |
| Affiliation |
Sapthagiri Institute Of Medical Sciences And Research Centre |
| Address |
Sapthagiri Institute Of Medical Sciences And Research Centre
DepartmentofAnaesthesiology
Division-Anaesthesiology
Room no: OT 1,2 and 3 Ground floor
15,Hesarghatta main road,Chikkabanavara, Bangalore 560090
Bangalore
KARNATAKA
560090
India |
| Phone |
8668024382 |
| Fax |
|
| Email |
ssoundaryav@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrPrashanth Prabhu J |
| Designation |
Professor |
| Affiliation |
Sapthagiri Institute Of Medical Sciences And Research Centre |
| Address |
Sapthagiri Institute Of Medical Sciences And Research Centre,
Department of Anaesthesiology
Division- Anaesthesiology
Room no:1,2 and 3 Ground floor
15,Hesarghatta main road,Chikkabanavara, Bangalore 560090
Bangalore
KARNATAKA
560090
India |
| Phone |
9035067161 |
| Fax |
|
| Email |
prashanthjnpl@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrPrashanth Prabhu J |
| Designation |
Professor |
| Affiliation |
Sapthagiri Institute Of Medical Sciences And Research Centre |
| Address |
Sapthagiri Institute Of Medical Sciences And Research Centre
Department of Anaesthesiology Division-Anaesthesiology
Room number -OT complex 1,2 and 3 .
15,Hesarghatta main road,Chikkabanavara, Bangalore 560090
Bangalore
KARNATAKA
560090
India |
| Phone |
9035067161 |
| Fax |
|
| Email |
prashanthjnpl@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sapthagiri Institute Of Medical Sciences And Research Centre
,Department of Anaesthesiology |
|
|
Primary Sponsor
|
| Name |
Sapthagiri Institute Of Medical Sciences And Research Centre |
| Address |
Hesarghatta main road, Chikkabanavara,Bangalore
560090 |
| Type of Sponsor |
Private 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 |
| DrVenkatesh Soundarya |
Sapthagiri Institute Of Medical Sciences And Research Centre |
Sapthagiri Institute Of Medical Sciences And Research Centre
Department of Anaesthesiology
Division - Anaesthesiology
Room number OT complex 1,2 and 3 Ground floor
15,Hesarghatta main road, Chikkabanavara,Bangalore
560090
Bangalore
KARNATAKA |
08668024382
ssoundaryav@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sapthagiri Institute Of Medical Sciences And Research Centre Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dexmedetomidine nebulisation |
Dexmedetomidine nebulisation 0.5mcg/kg 30min before surgery |
| Intervention |
Magnesium Sulphate nebulisation |
Magnesium Sulphate nebulisation 10mg/kg preoperatively 30min before surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA 1 and 2
2.General anaesthesia requiring Endotracheal intubation
3.Informed consent |
|
| ExclusionCriteria |
|
|
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 |
| Hemodynamic response to intubation by evaluation of heart rate, systolic BP, diastolic BP, mean BP. |
At baseline, After intubation,2 min ,5 min,10 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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)
|
07/10/2025 |
| 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="3"
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
|
Modern Anaesthesia is safe, balanced and of utmost importance to improve surgical outcome. So, it is essential to decrease the incidence and severity of anaesthesia related complications. Laryngoscopy and endotracheal intubation are associated with hemodynamic response which is characterized by increase in heart rate and blood pressure. These transient responses are normally harmless in healthy people, but can be dangerous in patients with reactive airways, hypertension, coronary artery diseases, cerebrovascular disorders. So, all efforts are made to decrease hemodynamic response in patients undergoing general anaesthesia with endotracheal intubation. Numerous drugs such as opioids, beta blockers and intravenous lignocaine are used to attenuate this hemodynamic response. The study is conducted to compare the incidence of preoperative nebulisation with magnesium sulphate and dexmedetomidine for hemodynamic response to Laryngoscopy and endotracheal intubation
|