| CTRI Number |
CTRI/2024/07/070364 [Registered on: 10/07/2024] Trial Registered Prospectively |
| Last Modified On: |
17/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparision of ketamine and magnesium sulfate nebulization to prevent sore throat after surgery in patients undergoing general anaesthesia. |
|
Scientific Title of Study
|
A comparative evaluation of nebulized ketamine and nebulized magnesium sulfate for attenuating the post operative sore throat in patients undergoing surgery under general anaesthesia: A double blinded randomized clinical trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 17 |
Protocol Number |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prem Kumar P |
| Designation |
Post graduate trainee |
| Affiliation |
Regional Institute of Medical Sciences Imphal Manipur |
| Address |
Department of Anaesthesiology
Regional Institute of Medical Sciences
Imphal
Imphal West MANIPUR 795004 India |
| Phone |
9677675822 |
| Fax |
|
| Email |
prempalani1997@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
L Pradipkumar Singh |
| Designation |
Professor |
| Affiliation |
Regional Institute of Medical Sciences Imphal Manipur |
| Address |
Department of Anaesthesiology
Regional Institute of Medical Sciences
Imphal
Imphal West MANIPUR 795004 India |
| Phone |
7005238251 |
| Fax |
|
| Email |
drlaithangba@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
L Pradipkumar Singh |
| Designation |
Professor |
| Affiliation |
Regional Institute of Medical Sciences, Imphal, Manipur |
| Address |
Department of Anaesthesiology,
Regional Institute of Medical Sciences,
Imphal
Imphal West MANIPUR 795004 India |
| Phone |
7005238251 |
| Fax |
|
| Email |
drlaithangba@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Regional Institute of Medical Sciences, Imphal, Manipur |
|
|
Primary Sponsor
|
| Name |
Prem Kumar P |
| Address |
Regional Institute of Medical Sciences,
Imphal, Manipur-795004 |
| 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 PREM KUMAR P |
Regional Institute of Medical Sciences, Imphal west, Manipur |
Elective surgery Operation Theatre complex (OT 1-9),
Department of Anaesthesiology,
Regional Institute of Medical Sciences Imphal West MANIPUR |
9677675822
prempalani1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Ethics Board, Regional Institute of Medical Sciences, Imphal, Manipur |
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 |
Nebulization of 250mg Magnesium Sulfate in 5ml Normal saline in pre operative room |
Study participants will be randomized into two groups. Intervention group receiving Nebulization of 250mg Magnesium Sulfate in 5ml Normal saline in pre operative room before 15 minutes of pre medication. |
| Intervention |
Nebulization of 50mg Ketamine in 5ml normal saline in pre operative room |
Study participants will be randomized into two groups. Intervention group receiving Nebulization of 50mg Ketamine in 5ml Normal saline in pre operative room before 15 minutes of pre medication. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either sex.
2. Patients of age group 18 to 65 years.
3. Patients of American Society of Anaesthesiologists (ASA) Physical grade I or II. |
|
| ExclusionCriteria |
| Details |
1. Patients with history of post operative sore throat.
2. Patients with history of recent respiratory tract infection.
3. Patients with history of chronic obstructive pulmonary disease, asthma, head and neck surgery.
4. Patients with inserted nasogastric tube.
5. History of allergy to study drugs and recent NSAIDs medication and steroids.
6. Patient unwillingness/ refusal. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| post operative sore throat |
Outcome will be assessed in post operative period at 0,2,4 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="142" Sample Size from India="142"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="144" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/07/2024 |
| Date of Study Completion (India) |
15/10/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Despite the emergence of new airway devices in the recent years, rigid laryngoscopy and tracheal intubation still remains the gold standard in airway management. Tracheal intubation is a commonly used technique in general anaesthesia, but it can cause a few side effects, including sore throat and hoarseness. These symptoms, known as postoperative sore throat (POST) which occurs in 21–65% of patients receiving general anaesthesia (GA) with tracheal intubation. POST had been rated by patients as the eighth most adverse effect in the postoperative period. Although POST is a minor side effect and is self-limiting, it causes a great deal of patient dissatisfaction. So prophylactic management of POST is recommended to improve the quality of post- anaesthesia care, though the symptoms resolve spontaneously without any treatment in most of the cases. A previously studies had shown comparison between magnesium and ketamine gargle efficacy in decreasing the incidence of POST, but nebulization is superior to gargle. In this study we compare the effect of Nebulized Ketamine and Nebulized Magnesium sulphate to prevent Post operative sore throat. This study will be prospective, double blinded randomized clinical trial to compare the effects of Nebulized ketamine versus Nebulized Magnesium sulfate for the Prevention of Post operative sore throat. A total of 142 patients of either sex will be selected for the study and divided into 2 groups Group K will receive Nebulization of ketamine 50mg in 5ml Normal saline and Group M will receive Nebulization of Magnesium sulphate 250mg in 5ml Normal saline. The patients will be looked for Post operative sore throat and if present, will be scored as 0 = No sore throat, 1 = Mild sore throat, 2 = Moderate sore throat, 3 = Severe sore throat. The data will be entered in SPSS version 26.0 and analysed using ANOVA test or Pearson Chisquare test as where appropriate. |