| CTRI Number |
CTRI/2024/03/064129 [Registered on: 14/03/2024] Trial Registered Prospectively |
| Last Modified On: |
07/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Compaison between two drugs,magnesium sulphate and ropivacaine as nebulization to facilitate endotracheal intubation in general anesthesia |
|
Scientific Title of Study
|
To comapre the effect of magnesium sulphate versus ropivacaine nebulization in patients undergoing endotracheal intubation under general anesthesia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deeksha Agrawal |
| Designation |
Junior Resident |
| Affiliation |
Teerthanker Mahaveer Medical College and Research Centre |
| Address |
Room no. 204 2nd Floor Teerthanker Mahaveer Medical College and Research Centre Moradabad UP
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
7302634094 |
| Fax |
|
| Email |
deekshaagrawal07468@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pallavi Ahluwalia |
| Designation |
Professor |
| Affiliation |
Teerthanker Mahaveer Medical College and Research Centre |
| Address |
Room No. 204 2nd Floor Teerthanker Mahaveer Medical College and Research Centre Moradabad UP
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
8218628850 |
| Fax |
|
| Email |
drpallaviahluwalia@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Md Shahbaz Alam |
| Designation |
Professor |
| Affiliation |
Teerthanker Mahaveer Medical College and Research Centre |
| Address |
Room no.204,2nd Floor Teerthanker Mahaveer Medical College and Research Centre Moradabad UP
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9897907372 |
| Fax |
|
| Email |
dralamshahbaz006@gmail.com |
|
|
Source of Monetary or Material Support
|
| Teerthanker Mahaveer Medical College,Moradabad,Uttar Pradesh |
|
|
Primary Sponsor
|
| Name |
Teerthanker Mahaveer Medical College Moradabad |
| Address |
Teerthanker Mahaveer Medical College Moradabad Uttar pradesh |
| 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 |
| Dr Deeksha Agrawal |
Teerthanker Mahaveer Medical College Moradabad,Uttar Pradesh |
Room no.204 2nd floor Department of Anesthesia
Moradabad
UTTAR PRADESH |
7302634094
deekshaagrawal07468@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE,T.M.UNIVERSITY,MORADABAD,UTTAR PRADESH |
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 |
MAGNESIUM SULPHATE |
To compare effect of Magnesium Sulphate Nebulization 250mg(2.5)plus 2.5ml 0.9%normal saline
2o minutes prior to induction for 10-15minutes |
| Intervention |
Ropivacaine |
To compare effect of Ropivacaine Nebulization 0.25%(5ml)
20 minutes before induction for 10-15minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients of American society of Anesthesiologists 1 and 2,Undergoing elective surgery under general anesthesia with endotracheal intubation |
|
| ExclusionCriteria |
| Details |
History of recent respiratory infections, Patient using steroids, Hypersensitivity to drugs, Pregnancy, Anticipated difficult airway |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Each participant in the study will be assessed for following Primary outcome parameters are as follows:-
1.To compare the severity of post operative sore throat.
|
Each participant in the study will be assessed for following Primary outcome parameters are as follows:-
1.To compare the severity of post operative sore throat.
Parameters recorded at after extubation in PACU( at o hour),at 2 hr,4hr,8hr,12hr and after 24 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Each participant in the study will be assessed for following Secndary outcome parameters are as follows
To compare the effect of preoperative nebulization on hemodynamic response to intubation in both the groups.
To compare the effect of preoperative nebulization on hemodynamic response to extubation in both the group.Â
To compare effects of post operative cough & hoarseness in both the groups.
To record complications if any. |
Will be nebulised 20 minutes before surgery & Haemodynamic parameter will be assessed baseline & after nebulization in preoperatively After induction Hemodynamic parameter will be assessed intraoperatively after induction at 5min & then every 10min till the extubation at 5min & 10min post extubation
Post operative cough recorded in PACU 0 Hour at 2hr at 4 hr at 8 hr at 12 hr at 24hr
|
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
20/03/2024 |
| 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="3"
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
|
This study is planned in context of to compare preoperative nebulisation with Magnesium Sulphate or Ropivacaine and its effect on attenuation of stress response at intubation and extubation and to note any effect on post operative sore throat.
|