| CTRI Number |
CTRI/2025/10/096508 [Registered on: 28/10/2025] Trial Registered Prospectively |
| Last Modified On: |
24/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effectiveness of magnesium sulphate, lignocaine and dexmedetomidine in attenuating the stress response during tracheal extubation- prospective randomized study |
|
Scientific Title of Study
|
Effect of Magnesium sulphate,Lidocaine and Dexmedetomidine on tracheal extubation response in patients under General anaesthesia - A double blinded randomised comparative prospective study |
| 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 Ajith K N |
| Designation |
post graduate student |
| Affiliation |
Kidwai Memorial Institute of Oncology |
| Address |
Department of Anaesthesia and pain relief
Kidwawi Memorial Institute on Oncology
Dr. M H Marigowda Road
Bangalore
Bangalore
KARNATAKA
560029
India |
| Phone |
7019079776 |
| Fax |
|
| Email |
doctor.ajithkn@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mamatha H S |
| Designation |
Associate Professor |
| Affiliation |
Kidwai Memorial Institute of Oncology |
| Address |
Department of Anaesthesia and pain relief
Kidwawi Memorial Institute on Oncology
Dr. M H Marigowda Road
Bangalore
Bangalore
KARNATAKA
560029
India |
| Phone |
7624815394 |
| Fax |
|
| Email |
drmamathah@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajith K N |
| Designation |
post graduate student |
| Affiliation |
Kidwai Memorial Institute of Oncology |
| Address |
Department of Anaesthesia and pain relief
Kidwawi Memorial Institute on Oncology
Dr. M H Marigowda Road
Bangalore
Bangalore
KARNATAKA
560029
India |
| Phone |
7019079776 |
| Fax |
|
| Email |
doctor.ajithkn@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kidwai memorial Institute of oncology |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Kidwai Memorial Institue of Oncology] |
|
|
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 Mamatha H S |
Kidwai Memorial Institute of Oncology |
Department of Anaesthesia and pain relief
Kiwdai Memorial Institute on Oncology
Dr M H Marigowda road, Bangalore 560029
Bangalore
KARNATAKA |
7624815394
drmamathah@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MEDICAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dexmedetomidine |
Dexmedetomidine 0.5 micrograms per kg bodyweight will be administred once the last stitch on the skin is place by the surgeon,the last painful stimulus of surgery |
| Comparator Agent |
Lidocaine |
Lidocaine 1.5 milligrams per kg body weight will be administered once the last stitch on the skin is placed by the surgeon, the last painful stimulus of the surgery |
| Intervention |
Magnesium sulphate |
Magnesium sulphate 30 milligrams per kg body weight shall be administered once the last stitch on the skin is placed by the surgeon the last painful stimulus of the surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing elective oncosurgery under general anaesthesia
ASA grade I and II
Mallampati grade I or II
|
|
| ExclusionCriteria |
| Details |
History of Asthma or COPD
Substance abuse, smoking , sedatives
Active airway infection or history of tracheal or laryngeal surgery |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the efficacy of intravenous magnesium sulphate, lidocaine and dexmedetomidine in attenuating
(1) Hemodynamic responses ( Heart rate and blood pressure ) during tracheal extubation
(2) Tracheal responses ( bucking, coughing and desaturation) during tracheal extubation |
(1) Immediately before extubation
(2) Immediately after extubation
(3) Every 5minutes for first 60 minutes and 2 hours after extubation
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the time to extubation & recovery characteristics
To assess sedation levels post extubation
To monitor any adverse effects related to these agents |
(1) Immediately after extubation
(2) Every 5minutes for first 60 minutes & 2 hours after extubation
|
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
10/11/2025 |
| 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="2"
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
|
Tracheal extubation is a critical phase of general anaesthesia and is not simply a reversal of the process of intubation because conditions are often less favourable that at the start of anaesthesia . At extubation, there is a transition from a controlled to an uncontrolled situation often associated with undesirable airway and hemodynamic responses including coughing, hypertension, tachycardia, laryngospasm and increased intracranial or intraocular pressure. These responses can lead to significant complications, especially in high risk patients. To mitigate these effects, several agents have been used. Magenisum sulphate acts as a calcium antagonist and NMDA receptor blocker, providing smooth muscle relaxation and attenuation of sympathetic responses. Lidocaine, a local anesthetic, stabilizes neuronal membranes and suppresses airway reflexes. Dexmedetomidine, a selective alpha 2 adrenergic agonist offers sedation, analgesia and sympatholysis, thus promoting smooth extubation. This study aims to compare the effictiveness of magnesium sulphate, lidocaine and dexmedetomidine in attenuating extubation responses in patients undergoing oncosurgery under general anaesthesia |