| CTRI Number |
CTRI/2025/03/081734 [Registered on: 06/03/2025] Trial Registered Prospectively |
| Last Modified On: |
04/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
preoperative nebulization with ketamine will be compared with lignocaine in patients undergoing general anaesthesia in prevention of sore throat. |
|
Scientific Title of Study
|
Comparison of preoperative nebulization with lignocaine versus ketamine in prevention of sore throat in patients undergoing general anaesthesia |
| 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 Shivani Sharma |
| Designation |
Junior Resident |
| Affiliation |
Maharishi Markandeshwar Medical College |
| Address |
Department of Anaesthesiology, 3rd floor Maharishi Markandeshwar Medical College and Hospital Kumarhatti Solan , Himachal Pradesh
Solan
HIMACHAL PRADESH
173229
India |
| Phone |
8628891048 |
| Fax |
|
| Email |
100shivani.sharma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Balvir Singh Sekhon |
| Designation |
Professor |
| Affiliation |
Maharishi Markandeshwar Medical College |
| Address |
Department of Anaesthesiology, 3rd floor Maharishi Markandeshwar Medical College and Hospital Kumarhatti Solan , Himachal Pradesh
Solan
HIMACHAL PRADESH
173229
India |
| Phone |
9814030551 |
| Fax |
|
| Email |
drbsekhon@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivani sharma |
| Designation |
Junior Resident |
| Affiliation |
Maharishi Markandeshwar Medical College |
| Address |
Department of Anaesthesiology, 3rd floor Maharishi Markandeshwar Medical College and Hospital Kumarhatti Solan , Himachal Pradesh
Solan
HIMACHAL PRADESH
173229
India |
| Phone |
8628891048 |
| Fax |
|
| Email |
100shivani.sharma@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharishi Markandeshwar Medical College and Hospital, Kumarhatti, Solan, Himachal pradesh India
173229
|
|
|
Primary Sponsor
|
| Name |
Shivani Sharma |
| Address |
Department of Anaesthesiology, Third floor, Maharishi Markandeshwar Medical college and Hospital, kumarhatti
solan. |
| 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 Shivani Sharma |
Maharishi Markandeshwar Medical College and Hospital |
O.T Complex Department of Anaesthesiology, 3rd floor 301 Maharishi Markandeshwar Medical College and Hospital Kumarhatti Solan , Himachal Pradesh
Solan
HIMACHAL PRADESH |
08628891048
100shivani.sharma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maharishi markandeshwar medical college |
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 + Normal Saline 0.9% |
50 mg(1ml) Ketamine + Normal saline 0.9% (1ml) nebulisation will be given to patient 15 minutes prior shifting to O.T. |
| Comparator Agent |
Lignocaine 2% + Normal Saline 0.9% (1ml) |
Lignocaine 2% (1ml)+ Normal saline 0.9% (1ml) nebulisation will be given to patient 15 minutes prior shifting to O.T. |
| Intervention |
Normal Saline 0.9% |
Intensity of Post operative sore throat in patients undergoing general anesthesia with nebulization with Normal Saline, Ketamine and Lignocaine will be compared. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) ASA grade 1 and 2
2) Age : Between the ages of 18 and 70, enrolled for elective surgery required for 2 hours of endotracheal intubation while under general anaesthesia.
|
|
| ExclusionCriteria |
| Details |
1) Patient that decline for participation in trial.
2) Patient allergic to ketamine or lignocaine.
3) Patient cough or bucked during intubation and extubation.
4) BMI more than 35 kg/ meter square.
5) Patient with history of previous sore throat or taking steroids or analgesia in last 48 hours
6) COPD, asthma, neuromuscular disease, difficult intubation.
|
|
|
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 |
| To assess and compare the intensity of Post-Operative sore throat in patients with Pre-Operative nebulization with lignocaine and ketamine undergoing general anaesthesia with endotracheal intubation. |
Hemodynamic variables will continued to be monitored at baseline to 4 hours, 6 hours, 12 hours and then 24 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the hemodynamic alterations and side effects, such as sedation, dry mouth, nausea, cough and vomiting during the study. |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
17/03/2025 |
| 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
|
Group K- It includes patients nebulized with ketamine 50 mg (1ml)+ Normal saline (1ml) Group L- It includes patients nebulized with Lignocaine 2% (1ml) + Normal Saline (1ml) Group C- It includes patients nebulized with Normal saline (2ml) |