| CTRI Number |
CTRI/2025/01/079710 [Registered on: 29/01/2025] Trial Registered Prospectively |
| Last Modified On: |
24/03/2024 |
| 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
|
To compare the effect of intravenous magnesium sulphate and nebulization of magnesium sulphate on intubation response and peak airway pressures in patients undergoing laparoscopic surgeries |
|
Scientific Title of Study
|
A comparative study of intravenous magnesium sulphate and nebulization of magnesium sulphate on attenuation of intubation response and airway pressure in patients undergoing laparoscopic surgeries, a randomized control trial. |
| 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 Sathya H |
| Designation |
PG Resident |
| Affiliation |
Bangalore Medical College and Research institute, Bangalore |
| Address |
Department of Anaesthesiology,
3rd floor,MPB Building, Bangalore Medical College and Research Institute, Bangalore
Bangalore
KARNATAKA
560002
India |
| Phone |
9611956787 |
| Fax |
|
| Email |
sathya551997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chiranthkumar G Nelogal |
| Designation |
Assistant Professor |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Department of Anaesthesiology,
3rd floor, MPB building, Bangalore Medical College and Research Institute, Bangalore
Bangalore
KARNATAKA
560002
India |
| Phone |
9686325147 |
| Fax |
|
| Email |
chiranth.nelogal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chiranthkumar G Nelogal |
| Designation |
Assistant Professor |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Department of Anaesthesiology,
3rd floor, MPB building ,Bangalore Medical College and Research Institute, Bangalore
Bangalore
KARNATAKA
560002
India |
| Phone |
9686325147 |
| Fax |
|
| Email |
chiranth.nelogal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia, MPB 3rd floor, Bangalore Medical College and research institute, Bangalore 560002 |
|
|
Primary Sponsor
|
| Name |
Bangalore Medical College and Research Institute |
| Address |
Fort, Krishna Rajendra road, Kalasipalya, Bengaluru 560002 |
| 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 Chiranth Kumar Nelogal |
Bangalore Medical College and Research institute |
Department of Anaesthesia MPB Building 3rd floor ,Fort , Krishna Rajendra Road , Kalasipalya, Bengaluru, Karnataka 560002
Bangalore
KARNATAKA |
9686325147
chiranth.nelogal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bangalore Medical College and Research Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intravenous magnesium sulphate |
Intravenous magnesium sulphate at 30mg/kg over 20 minutes before induction of anaesthesia |
| Intervention |
Nebulization of Magnesium Sulphate |
Nebulization of Magnesium Sulphate 250mg made to 5ml by adding sterile water 10 minutes before induction of anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged between 18 to 60 years .
Patients willing to give informed written consent
Patients with ASA Grade 1 and Grade 2
Patients scheduled for surgeries under general anaesthesia for laparoscopy. |
|
| ExclusionCriteria |
| Details |
Patients refusal to give informed written consent
Patients belonging to ASA Grade 3, 4, 5
Patients with cardiovascular, respiratory, renal and hepatic derangement
Patients with history of drug allergy
Pregnant women
Patients with anticipated difficult airway |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare hemodynamic response after intubation. |
AT Basal, 2min, 5 min and 7 min after intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare peak airway pressures after intubation. |
At Basal , 2 min , 5 min, 7 min after intubation |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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 |
|
Date of First Enrollment (India)
|
10/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/02/2025 |
| 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 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 - NO
|
|
Brief Summary
|
Endotracheal intubation is an important component of general anesthesia. Laryngoscopy causes stimulation of sympathetic nervous system and causes increase in concentration of catecholamines like adrenaline and noradrenaline. This can cause left ventricular failure, renal failure, surgical bleeding, cerebral hemorrhage and myocardial ischemia in patients with general anesthesia. Various drugs like Magnesium sulphate , lidocaine, dexmedetomidine can be used in attenuating response to intubation. The current Randomized controlled trial is carried out to compare attenuation response of magnesium sulphate in two different route of administration i.e, intravenous and nebulization as studies comparing them are scarce. |