| CTRI Number |
CTRI/2025/09/094955 [Registered on: 17/09/2025] Trial Registered Prospectively |
| Last Modified On: |
16/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study comparing Preoperative Nebulization with Magnesium Sulphate versus Lignocaine to Prevent Post Extubation Sore Throat in Patients undergoing Laparoscopic Surgeries at SMS Medical College, Jaipur. |
|
Scientific Title of Study
|
A Randomized comparative Study To Assess Post Extubation Sore Throat using Preoperative Nebulization with Magnesium Sulphate versus Lignocaine in Patients undergoing Laparoscopic Surgeries at SMS Medical College, Jaipur. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arunkumar |
| Designation |
PG Resident |
| Affiliation |
SMS Medical College ,Jaipur |
| Address |
Department of Anaesthesiology,SMS Medical College,JLN Marg,Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9487792547 |
| Fax |
|
| Email |
arunvirat91098@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harpreet Kaur |
| Designation |
Senior Professor |
| Affiliation |
SMS Medical College |
| Address |
Department of Anaesthesiology,SMS Medical College,JLN Marg,Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9899785993 |
| Fax |
|
| Email |
rupihar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arunkumar |
| Designation |
PG Resident |
| Affiliation |
SMS Medical College ,Jaipur |
| Address |
Department of Anaesthesiology,SMS Medical College,JLN Marg,Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9487792547 |
| Fax |
|
| Email |
arunvirat91098@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology,2nd floor,Dhanvantri Complex,SMS Medical College and Hospital,Jaipur 302004,Rajasthan,India |
|
|
Primary Sponsor
|
| Name |
SMS Medical College and Hospital |
| Address |
Department of Anaesthesiology,Dhanvantri Complex,SMS Medical College and Hospital,Jaipur 302004,Rajasthan,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 Harpreet Kaur |
General Surgery Operation Theatre,SMS Medical College,Jaipur |
Department of Anaesthesiology,Dhanvantri Complex,SMS Medical College and Hospital,Jaipur 302004,Rajasthan,India
Jaipur
RAJASTHAN |
9899785993
rupihar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of the Ethics Committee,S.M.S Medical College and Attached Hospitals,Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, (2) ICD-10 Condition: K402||Bilateral inguinal hernia, withoutobstruction or gangrene, (3) ICD-10 Condition: K819||Cholecystitis, unspecified, (4) ICD-10 Condition: K358||Other and unspecified acute appendicitis, (5) ICD-10 Condition: K429||Umbilical hernia without obstruction or gangrene, (6) ICD-10 Condition: N950||Postmenopausal bleeding, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lignocaine Group |
Nebulization of patients 30 minutes prior to surgery using 4 ml of 2 percentage Lignocaine over 15 minutes. |
| Comparator Agent |
Magnesium Sulphate |
Nebulization of patients 30 minutes prior to surgery using 4ml of 6.25 percentage of Magnesium Sulphate over 15 minutes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients undergoing elective laparoscopic surgeries under General Anaesthesia.
2.Patients giving written informed consent
3.Patients having American Society of Anesthesiologist (ASA) physical status 1 and 2.
4.Patients of age more than 18 years.
5.Patients with Mallampati grade 1 or 2.
|
|
| ExclusionCriteria |
| Details |
1.Patient who is part of any other study.
2.Patients with upper respiratory tract infection.
3.Patients with nasogastric tube and any nasal or throat pack require intraoperatively.
4.Allergy to study drugs.
|
|
|
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 |
| 1.To assess and compare the proportion of sore throat ( swallowing and rest) between two groups after extubation till 48 hours. |
1.Postoperative sore throat will be checked ( swallowing and rest) between two groups at 2 hours,8hours,24hours and 48hours after extubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To assess & compare the proportion of hoarseness of voice & cough between two groups after extubation till 48 hours.
2.To assess & compare haemodynamic parameters-Heart rate,Systolic blood pressure,Diastolic blood pressure,Mean arterial pressure from induction to extubation at every 10 minutes interval.
3.To assess & compare side effects –nausea, vomiting, hypotension & respiratory depression in both groups.
|
1.Hoarseness of voice & Cough will be checked between two groups at 2hours,8hours,24hours & 48hours after extubation
2.Haemodynamic parameters-Heart rate,Systolic blood pressure,Diastolic blood pressure,Mean arterial pressure will be checked from induction to extubation at every 10 minutes interval.
3.Side effects –nausea, vomiting, hypotension & respiratory depression will be checked in both groups intraoperatively & postoperatively.
|
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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 3 |
|
Date of First Enrollment (India)
|
28/09/2025 |
| 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="0"
Months="5"
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
|
This prospective ,randomized comparative study is being conducted at S.M.S Medical College and Hospital,Jaipur to assess the post extubation sore throat using preoperative nebulization with 4ml of 6.25 percentage of Magnesium Sulphate and 4ml of 2 percentage Lignocaine in patients undergoing laparaoscopic surgeries.A total of 150 patients will be enrolled and randomized into two equal groups(Magnesium Sulphate group and Lignocaine group).Parameters such as postoperative sore throat at rest and swallowing,Hoarseness of voice ,Cough ,Adverse effects (nausea ,vomiting,hypotension and respiratory depression)and Intraoperative Haemodynamic parameters will be recorded at predefined intervals.The aim is to identify the group in which duration of postoperative sore throat at rest and swallowing is less compared to another group and ensuring haemodynamic stability with minimal adverse effects. |