| CTRI Number |
CTRI/2025/09/095191 [Registered on: 22/09/2025] Trial Registered Prospectively |
| Last Modified On: |
19/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study on the comparison between nebulization with ketamine and magnesium sulfate before the surgery in the prevention of after an operation sorethroat in patients going through general anaesthesia(putting the patient to sleep with medicine) with endotracheal intubation(breathing tube in throat) |
|
Scientific Title of Study
|
A study on the comparison between preoperative nebulization with magnesium sulfate and ketamine in the prevention of postoperative
sore throat during general anaesthesia with endotracheal intubation in adults |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nivitha G |
| Designation |
Post graduate student |
| Affiliation |
ESIC medical college and hospital, KK Nagar |
| Address |
ESIC medical college and hospital,
Department of Anaesthesia
B block, first floor, Operation theatre complex
Ashok pillar main road,
KK Nagar
Chennai
TAMIL NADU
600078
India |
| Phone |
8220752855 |
| Fax |
|
| Email |
nivitha.gandhi1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohan Kumar R.M. |
| Designation |
Post graduate student |
| Affiliation |
ESIC medical college and hospital, KK Nagar |
| Address |
ESIC medical college and hospital,
Department of Anaesthesia,
B block,first floor,Operation theatre complex
Ashok pillar main road
KK Nagar
Chennai
TAMIL NADU
600078
India |
| Phone |
7259383591 |
| Fax |
|
| Email |
drmohankumarrm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nivitha G |
| Designation |
Post graduate student |
| Affiliation |
ESIC medical college and hospital, KK Nagar |
| Address |
ESIC medical college and hospital,
Department of Anaesthesia
B block, first floor, Operation theatre complex
Ashok Pillar main road
Kk Nagar
Chennai
TAMIL NADU
600078
India |
| Phone |
8220752855 |
| Fax |
|
| Email |
nivitha.gandhi1996@gmail.com |
|
|
Source of Monetary or Material Support
|
| ESIC medical college and hospital
Department of Anaesthesia,
B block, first floor, Operation theatre complex,
Ashok Pillar main road
Kk Nagar
Chennai
Tamil Nadu
India
600078 |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesia |
| Address |
Department of Anaesthesia
ESIC medical college and hospital, KK Nagar
Chennai 600078
Tamilnadu
India |
| 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 Nivitha G |
ESIC medical college and hospital |
ESIC medical college and hospital,
Department of Anaesthesia,
B block, first floor, Operation theatre complex,
Ashok Pillar main road,
KK Nagar
Chennai
TAMIL NADU |
8220752855
nivitha.gandhi1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ESIC medical college and hospital |
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 |
Ketamine |
Nebulization with ketamine 50mg (diluted to 5ml with normal saline) will be given once using a wall-attached oxygen drive source 20 minutes before induction of general anaesthesia until chamber empties and its effect on the prevention of postoperative sore throat, hoarseness of voice and cough will be studied |
| Intervention |
Magnesium sulfate |
Nebulization with magnesium sulfate 500mg (diluted to 5ml with normal saline) will be given once using a wall-attached oxygen drive source 20 minutes before induction of general anaesthesia until chamber empties and its effect on the prevention of postoperative sore throat, hoarseness of voice and cough will be studied |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients who have given written informed consent
2.ASA physical status 1 and 2
|
|
| ExclusionCriteria |
| Details |
1.Patients with known or anticipated difficult airway
2.Those who had undergone more than 3 attempts at intubation and those requiring airway adjuncts
3.Emergency surgeries
4.BMI more than 35
5.Pregnancy and lactation
6.History of preoperative sore throat or recent upper respiratory tract infection
7.History of oral surgeries, neck surgeries like thyroid surgery |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the incidence of postoperative sore throat (POST) in adult patients undergoing general anesthesia with endotracheal intubation between patients who received preoperative nebulization with ketamine 50mg and magnesium sulfate 500mg |
Postoperatively at 0,2,4,6 and 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To assess the severity of POST (mild, moderate, or severe) in patients who received nebulized ketamine and nebulized magnesium sulfate
2)To evaluate the incidence of other complications in patients who received nebulized ketamine and magnesium sulfate, such as hoarseness of voice and cough |
Postoperatively at 0,2,4,6 and 24 hours |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/10/2025 |
| 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="6"
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 - NO
|
|
Brief Summary
|
A prospective randomized double blind study titled comparison between preoperative nebulization with magnesium sulphate and ketamine in the prevention of postoperative sore throat will be undertaken at ESIC Medical College a Hospital, Chennai. The study will be conducted on 70 patients belonging to ASA 1 and 2 undergoing elective surgery under general anaesthesia with endotracheal intubation. Study subjects will be divided into two study groups. Patients in Group A will be nebulized with Magnesium Sulphate 500mg, Group B with Ketamine 50mg . Nebulization will be administered 20 minutes prior to the surgery. Postoperatively patients will be assessed for incidence and severity of POST, hoarseness of voice, and cough at intervals of 0, 2, 4, 6 and 24 hours using a 4 point scale. All continuous variables will be expressed in terms of descriptive statistics such as mean, standard deviation, range, standard error etc. Categorical data will be expressed in terms of frequency and percentage. |