| CTRI Number |
CTRI/2024/02/062836 [Registered on: 19/02/2024] Trial Registered Prospectively |
| Last Modified On: |
13/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To study and compare the effect of preoperative nebulized Magnesium sulphate versus Lignocaine in reducing the incidence of post-operative sore throat in patients undergoing surgery under general anaesthesia |
|
Scientific Title of Study
|
To study and compare the effect of preoperative nebulized Magnesium sulphate versus Lignocaine in reducing the incidence of post-operative pharyngo-laryngeal complications in patients undergoing surgery under general anaesthesia with cuffed Endotracheal tube - A prospective triple blind randomised 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 |
Supriya |
| Designation |
Junior resident |
| Affiliation |
Dr Rajendra Prasad Government Medical College Tanda Kangra Himachal Pradesh |
| Address |
Room Number 101
Operation Theatre complex 3rd Floor
Department Of Anaesthesia
Dr Rajendra Prasad Government Medical College Tanda Kangra Himachal Pradesh
Room Number 401
Veer Savarkar Girls Hostel
Dr Rajendra Prasad Government Medical College Tanda Kangra Himachal Pradesh
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
8580991452 |
| Fax |
|
| Email |
Supriyathakur65@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhanu |
| Designation |
Assistant Professor |
| Affiliation |
Dr Rajendra Prasad Government Medical CollegeTanda Kangra Himachal Pradesh |
| Address |
Room Number 104
Operation theatre Complex 3rd Floor
Department of Anaesthesia
Dr Rajendra Prasad Government Medical College Tanda Kangra Himachal Pradesh
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418016807 |
| Fax |
|
| Email |
bhanurpgmc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Supriya |
| Designation |
Junior resident |
| Affiliation |
Dr RPGMC Tanda Kangra |
| Address |
Room Nymber 101
Operation theatre Complex 3rd Floor
Department of Anaesthesia
Dr Rajendra Prasad Government Medical College Tanda Kangra Himachal Pradesh
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
8580991452 |
| Fax |
|
| Email |
Supriyathakur65@gmail.com |
|
|
Source of Monetary or Material Support
|
| Medical Superintendent Office
Room No.203 First Floor(Block A)
Dr Rajendra Prasad Government Medical College Tanda Kangra Himachal Pradesh |
|
|
Primary Sponsor
|
| Name |
Supriya |
| Address |
Army colony Tanda Kangra HP |
| Type of Sponsor |
Other [self] |
|
|
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 Supriya |
Dr Rajendra Prasad Government Medical College Tanda Kangra Himachal Pradesh |
Operation Theatre Complex 3rd Floor
Pre-operative room
Department of Anaesthesia
Kangra
HIMACHAL PRADESH |
8580991452
Supriyathakur65@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee Dr RPGMC Tanda |
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 |
| Intervention |
Comparison of Magnesium sulfate and lignocaine in reducing pharyngolaryngeal complications |
Patients are randomly selected and nebulized with Magnesium sulfate 250mg and Lignocaine 100 mg for 15 min before surgery.Patients are then followed up for developing pharyngolaryngeal complications
Total duration of this study will be 12 months. |
| Comparator Agent |
Nebulization with Magnesium sulfate and Lignocaine |
Nebulization done with Magnesium sulfate and Lignocaine before surgery to know which drug is more effective in reducing incidence of pharyngolaryngeal complications
Total duration of study will be 12 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA class I-II
BMI 18.5-29.9
Undergoing elective surgeries requiring general anaesthesia with cuffed ETT of duration 60-120 minutes |
|
| ExclusionCriteria |
| Details |
Patients refusal for participation in study,hemodynamically unstable pt,history of hypersensitivity to drug used,history of active or recent URTI(last 6 weeks),trauma during intubation,patients on analgesics or steroids |
|
|
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 evaluate & compare the effectiveness of nebulized Magnesium sulfate & Lignocaine in:
a.Extubation quality score using 5 points extubation quality score.
b.Post extubation airway related adverse effects like cough,sore throat,hoarseness. |
2 hours,6 hours,12 hours, 24 hours, 48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To access the hemodynamic parameter during surgery & extubation.
2.To access the airway dynamics during surgery & extubation.
3.To study side effect of study drug if any.
4.Patient satisfaction score. |
2 hours
6 hours
12 hours
24 hours
48 hours |
|
|
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
28/02/2024 |
| 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="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 - 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 - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Data are available indefinitely at (Link to be included Supriyathakur65@gmail.com).
- For how long will this data be available start date provided 01-01-2025 and end date provided 01-01-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
We will be nebulizing patients with Magnesium sulfate 250mg and Lignocaine 100 mg over 15 minutes and then follow up patients for developing pharyngolaryngeal complications |