| CTRI Number |
CTRI/2023/03/050439 [Registered on: 07/03/2023] Trial Registered Prospectively |
| Last Modified On: |
03/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
comparing the effectiveness of nebulization by 2 drugs in reducing sore throat after surgery |
|
Scientific Title of Study
|
Comparison Of Efficacy of Dexamethasone Nebulisation versus Lignocaine Nebulisation in Prevention or Reduction of Postoperative Sore Throat(POST) after Endotracheal Intubation in Elective Surgeries done under General Anaesthesia. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR KIRAN A V |
| Designation |
ASSOSCIATE PROFESSOR |
| Affiliation |
MANDYA INSTITUTE OF MEDICAL SCIENCES |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
MANDYA INSTITUTE OF MEDICAL SCIENCES
MANDYA
DEPARTMENT OF ANAESTHESIOLOGY
MANDYA INSTITUTE OF MEDICAL SCIENCES
MANDYA
Mandya
KARNATAKA
571401
India |
| Phone |
8867917802 |
| Fax |
|
| Email |
virupaksha2614@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR KIRAN A V |
| Designation |
ASSOSCIATE PROFESSOR |
| Affiliation |
MANDYA INSTITUTE OF MEDICAL SCIENCES |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
MANDYA INSTITUTE OF MEDICAL SCIENCES
MANDYA
DEPARTMENT OF ANAESTHESIOLOGY
MANDYA INSTITUTE OF MEDICAL SCIENCES
MANDYA
KARNATAKA
571401
India |
| Phone |
8867917802 |
| Fax |
|
| Email |
virupaksha2614@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DR CHIDANAND HALAGATTI |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
MANDYA INSTITUTE OF MEDICAL SCIENCES |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
MANDYA INSTITUTE OF MEDICAL SCIENCES
MANDYA
DEPARTMENT OF ANAESTHESIOLOGY
MANDYA INSTITUTE OF MEDICAL SCIENCES
MANDYA
Mandya
KARNATAKA
571401
India |
| Phone |
7022764381 |
| Fax |
|
| Email |
chidanandveeranna@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mandya institute of medical sciences, Mandya |
|
|
Primary Sponsor
|
| Name |
DR KIRAN A V |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
MANDYA INSTITUTE OF MEDICAL SCIENCES
MANDYA |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DR CHIDANAND HALAGATTI |
DEPARTMENT OF ANAESTHESIOLOGY
MANDYA INSTITUTE OF MEDICAL SCIENCES
MANDYA |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR KIRAN A V |
MIMS, Mandya |
OT COMPLEX ,
DEPARTMENT OF ANAESTHESIOLOGY
MANDYA INSTITUTEOF MEDICAL SCIENCES
MANYA
Mandya
KARNATAKA |
8867917802
virupaksha2614@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITEE, MANDYA INSTITUTE OF MEDICAL SCIENCES |
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 |
| Intervention |
dexamethasone |
Patients who are undergoing elective surgeries done under general anaesthesia with endotracheal intubation and satisfies our study inclusion criteria in a year will be selected. The study will be prospective observational study with written informed consent obtained from the patients. Patients will be receiving nebulisation Dexamethasone 8 mg [2ml ] with 3 ml normal saline or nebulisation Lignocaine 2% 100mg [5 ml].
Patients will be receiving either nebulisation Dexamethasone 8 mg [2ml] with 3 ml normal saline (or) nebulisation Lignocaine 2% 100mg [5 ml ] 30 min prior to induction of general anaesthesia. |
| Comparator Agent |
lignocaine |
Patients who are undergoing elective surgeries done under general anaesthesia with endotracheal intubation and satisfies our study inclusion criteria in a year will be selected. The study will be prospective observational study with written informed consent obtained from the patients. Patients will be receiving nebulisation Dexamethasone 8 mg [2ml ] with 3 ml normal saline or nebulisation Lignocaine 2% 100mg [5 ml].
Patients will be receiving either nebulisation Dexamethasone 8 mg [2ml] with 3 ml normal saline (or) nebulisation Lignocaine 2% 100mg [5 ml ] 30 min prior to induction of general anaesthesia. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients belonging to American Society of Anaesthesiologists Physical Status grade I and II.
2.Patients posted for elective surgeries under general anaesthesia with tracheal intubation less than 4 hours.
3.Patients between age group 18 to 60 years.
4.Patients willing to give informed consent to participate in the study.
5.Mallampatti grade I and II.
6.Laryngoscopy done by experienced anaesthesiologist in single attempt.
|
|
| ExclusionCriteria |
| Details |
1.Patients with known hypersensitivity or contra-indications to study drugs.
2.Received drugs(other than study drugs) that prevent sore throat, 24 hours before anaesthesia..
3.Patients with Body mass index more than 30.
4.ASA grade III and IV
5.Mallampatti III and IV
6.History of URTI in previous 2 weeks
7.H/O smoking
8.More than 2 attempts at laryngoscopy and intubation
9.Patients who are on steroids
10.Patients requiring manipulation of airway or instrumentation(like oral airway,stylet,bougie, external laryngeal maneuver)
11.Pregnant patients
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of dexamethasone nebulization versus lignocaine nebulization in prevention or reduction of post operative sore throat(POST) |
0 hour , 2 hours , 4 hours , 6 hours , 12 hours , 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of dexamethasone nebulization versus lignocaine nebulization in prevention or reduction of post operative hoarseness and cough. |
0 hours , 2 hours , 4 hours , 6 hours , 12 hours , 24 hours |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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
|
N/A |
|
Date of First Enrollment (India)
|
23/03/2023 |
| 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
|
NONE YET |
|
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [chidanandveeranna@gmail.com].
- For how long will this data be available start date provided 27-09-2023 and end date provided 27-09-2026?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Patients who are
undergoing elective surgeries done under general anaesthesia with endotracheal intubation
and satisfies our study inclusion criteria in a year will be selected.Patients will be receiving
either nebulization Dexamethasone 8 mg [2ml] with 3 ml normal saline (or) nebulization Lignocaine 2% 100mg [5 ml ]
30 min prior to induction of general anaesthesia.The occurrence of sore throat, post operative hoarseness, cough and if any side effects will be assessed
postoperatively for 24h. |