| CTRI Number |
CTRI/2025/04/085152 [Registered on: 21/04/2025] Trial Registered Prospectively |
| Last Modified On: |
19/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of 2 drugs for reducing hemodynamic response during Intubation |
|
Scientific Title of Study
|
Comparative Study Of Nebulised Dexmedetomidine And Nebulised Magnesium Sulphate For Attenuation Of Haemodynamic Response During Laryngoscopy And 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 |
ASIF P |
| Designation |
Third Year PG Resident |
| Affiliation |
Sardar Patel Medical College, Bikaner, Rajasthan |
| Address |
Poonthottathil(House),Kadannamanna(PO),Mankada(VIA),Malappuram(DIST),Kerala(STATE),PIN:679324
Third Year PG Resident
Department Of Anaesthesia
Old PG Hostel
Room Number 15
Sardar Patel Medical College, Bikaner, Rajasthan
PIN:334001
Malappuram
KERALA
679324
India |
| Phone |
7025862867 |
| Fax |
|
| Email |
drasifmuhammedp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ANITA PAREEK |
| Designation |
Additional Principal And Senior Professor |
| Affiliation |
Sardar Patel Medical College, Bikaner, Rajasthan |
| Address |
Senior Professor
Department Of Anaesthesia Sardar Patel Medical College Bikaner
Rajasthan
334001
INDIA
Bikaner
RAJASTHAN
334001
India |
| Phone |
9828101281 |
| Fax |
|
| Email |
dranitapareek23@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ANITA PAREEK |
| Designation |
Additional Principal And Senior Professor |
| Affiliation |
Sardar Patel Medical College, Bikaner, Rajasthan |
| Address |
Senior Professor
Department Of Anaesthesia, Sardar Patel Medical College, Bikaner
Rajasthan
334001
INDIA
Bikaner
RAJASTHAN
334001
India |
| Phone |
9828101281 |
| Fax |
|
| Email |
dranitapareek23@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sardar Patel Medical College
Bikaner
Rajasthan
India
PIN CODE: 334001 |
|
|
Primary Sponsor
|
| Name |
Sardar Patel Medical College Bikaner Rajasthan |
| Address |
Department Of Anaesthesia, Sardar Patel Medical College, Bikaner, Rajasthan
India
PIN CODE:334001 |
| 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 Asif P |
Sardar Patel Medical College, Bikaner, Rajasthan |
Department Of Anaesthesia, Sardar Patel Medical College, Bikaner, Rajasthan.
Bikaner
RAJASTHAN |
7025862867
drasifmuhammedp@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical And Research Board, Sardar Patel Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, (2) ICD-10 Condition: K269||Duodenal ulcer, unspecified as acute or chronic, without hemorrhage or perforation, (3) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, (4) ICD-10 Condition: N630||Unspecified lump in unspecified breast, (5) ICD-10 Condition: K509||Crohns disease, unspecified, (6) ICD-10 Condition: H679||Otitis media in diseases classified elsewhere, unspecified ear, (7) ICD-10 Condition: K639||Disease of intestine, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nebulisation With Either Dexmedetomidine Or Magnesium Sulphate |
Patients are grouped in to two, and they are nebulised with Dexmedetomidine 1 microgram per kilogram and Magnesium sulphate 40 milligram per kilogram for 15 minutes |
| Comparator Agent |
Nebulised Dexmedetomidine and nebulised Magnesium Sulphate |
Comparison of Dexmedetomidine and Magnesium Sulphate in nebulised form, for reducing hemodynamic changes during Laryngoscopy and Intubation in patients undergoing surgery under General Anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA Grade 1 and 2, Age 18-35 years, BMI less than 30, Mallampati grading 1 and 2, Patients undergoing elective surgeries requiring General Anaesthesia with Endotracheal Intubation. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the hemodynamic effects of Nebulised Dexmedetomidine and Nebulised Magnesium Sulphate on the patient during Laryngoscopy and Intubation. |
Before nebulisation, After nebulisation.
2, 5, and 10 minutes following Intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe any side effects and complications related to the drugs. |
Intraoperative, Up to 24 hours Post-operatively. |
|
|
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 4 |
|
Date of First Enrollment (India)
|
30/04/2025 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
Laryngoscopy and Intubation are a crucial part of general anaesthesia in a patient undergoing surgery. Sympathetic stimulation and catecholamine release while performing Laryngoscopy and Intubation leads to hemodynamic changes ,mainly Tachycardia and Hypertension.
Many agents are in use for reducing these hemodynamic changes. We plan to use Dexmedetomidine and Magnesium Sulphate in nebulised form, in 90 patients, ASA grade 1 and 2 undergoing elective surgery who need Endotracheal Intubation. Our aim will be to compare the hemodynamic changes of these two drugs during Laryngoscopy and Intubation. We will also observe the side effects and complications if any. |