CTRI Number |
CTRI/2024/04/065794 [Registered on: 16/04/2024] Trial Registered Prospectively |
Last Modified On: |
15/04/2024 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug |
Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
|
comparing efficacy of preoperative magnesium sulphate nebulization with ketamine nebulization in reducing incidence of severity of post operative sore throat in patient undergoing surgery under general anesthesia., |
Scientific Title of Study
|
To study and compare the efficacy of preoperative Magnesium Sulphate nebulization with Ketamine nebulization In reducing the incidence and severity of post-operative pharyngolaryngeal complications - A prospective triple blinded randomised controlled 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 |
Shivakumar Kala Vaishnav Krishna |
Designation |
Junior resident |
Affiliation |
Dr Rajendra Prasad Governent Medical College Tanda,Kangra. |
Address |
Dr Rajendra Prasad Governent Medical College Tanda,Kangra.
Kangra HIMACHAL PRADESH 176001 India |
Phone |
7411276092 |
Fax |
|
Email |
vaishnavrgpmc@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Bhanu Gupta |
Designation |
Assistant Professor |
Affiliation |
Dr Rajendra Prasad Governent Medical College Tanda,Kangra. |
Address |
Dr Rajendra Prasad Governent Medical College Tanda,Kangra.
Kangra HIMACHAL PRADESH 176001 India |
Phone |
9418016807 |
Fax |
|
Email |
bhanurpgmc@gmail.com |
|
Details of Contact Person Public Query
|
Name |
shivakumar kala vaishnav krishna |
Designation |
Junior resident |
Affiliation |
Dr Rajendra Prasad Governent Medical College Tanda,Kangra. |
Address |
Dr Rajendra Prasad Governent Medical College Tanda,Kangra.
Kangra HIMACHAL PRADESH 176001 India |
Phone |
7411276092 |
Fax |
|
Email |
vaishnavrgpmc@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
dr vaishnav |
Address |
Room no 101,1st Floor Dr Rajendra Prasad Governent Medical College Tanda,Kangra.176002 |
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 Vaishnav |
Dr Rajendra Prasad Governent Medical College Tanda,Kangra. |
Room No 304, Preoperative Room,3rd Floor, OT Complex. Kangra HIMACHAL PRADESH |
7411276092
vaishnavrgpmc@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Dr RPGMC KANGRA at Tanda |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: O||Medical and Surgical, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Comparing postoperative sorethorat after nebulization with Magnesium Sulphate and Ketamine. |
Comparing Post operative Sorethroat at 2,6,12,24,48h. |
Intervention |
Patients are randomly selected and Nebulized with magnesium sulphate 250mg and ketamine 50mg for 15 mins before surgery. Patients are then followed up for developing pharnygolaryngeal complications total duration of this study will be 12months |
Nebulization done with Magnesium sulphate and ketamine before surgery to know which drug is more effective in reducing incidence of pharnygolaryngeal complications total duration of study will be 12months |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1.Males and females between the age group 18-60 years.
2. ASA class I-II.
3. Body mass index(BMI) 18.5-29.9.
4. Undergoing surgeries requiring general anaesthesia with cuffed ETT of duration 60-120 minutes. |
|
ExclusionCriteria |
Details |
1. Patient’s refusal participation in study.
2. Haemodynamically unstable patients.
3. History of hypertension, asthma, chronic obstructive pulmonary disease(COPD), cardiovascular disease, renal disease, diabetes mellitus, cerebrovascular disease.
4. Patients having known hypersensitivity to drugs under consideration.
5. Patient with three or more attempts at laryngoscopy or bougie for intubation.
6. Patients who sustained trauma while intubation or nasogastric tube insertion as evidenced by blood on cuff after extubation or blood stained secretions while suctioning before extubation.
7. Patient suffering from active or recent (past 6 weeks) upper airway tract infection (preoperative sore throat, cough) and edema/inflammation noticed during laryngoscopy.
8. Surgery requiring placement of nasogastric tube intraopeartively.
9. Patients already on analgesics or steroids (systemic or inhaled). |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
PRIMARY OBJECTIVES
1. To Evaluate & compare the effectiveness of nebulised Magnesium sulfate & ketamine in:
a. Extubation Quality using 5 point extubation quality score.
b. Post extubation airway related adverse effects like cough (POC), sore throat (POST) & hoarseness (POH).
SECONDARY OBJECTIVES
1. To access the haemodynamic parameter during surgery & extubation.
2. To access the airway dynamics during surgery & extubation.
3. To study side effect of study drugs if any.
4. Patient satisfaction score. |
2,4,6,12,24,48 hours |
|
Secondary Outcome
|
Outcome |
TimePoints |
SECONDARY OBJECTIVES
1. To access the haemodynamic parameter during surgery and extubation.
2. To access the airway dynamics during surgery and extubation.
3. To study side effect of study drugs if any.
4. Patient satisfaction score.
|
2,4,6,12,24,48hours |
|
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 2 |
Date of First Enrollment (India)
|
26/04/2024 |
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 Vaishnavrgpmc@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 ketamine 50mg over 15 minutes and then follow up patients for developing pharnygolaryngeal complications. |