| CTRI Number |
CTRI/2022/06/043373 [Registered on: 20/06/2022] Trial Registered Prospectively |
| Last Modified On: |
17/06/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To relieve post operative sore throat and cough after general anesthesia procedure |
|
Scientific Title of Study
|
Effectiveness of Preemptive Dextromethorphan lozenges for post operative sore throat : A Randomised controlled study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR MADHURI G |
| Designation |
POSTGRADUATE ANESTHESIOLOGY |
| Affiliation |
DR MGR UNIVERSITY |
| Address |
Department of Anesthesiology
Rajarajeshwari Medical College and Hospital
RAJA RAJESHWARI MEDICAL COLLEGE AND HOSPITAL, KENGERI HOBLI , BANGALORE 74
Bangalore
KARNATAKA
560074
India |
| Phone |
8861840505 |
| Fax |
|
| Email |
gmadhuri7914@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SOWMYA MJ |
| Designation |
PROFESSOR, ANESTHESIOLOGY |
| Affiliation |
DR MGR UNIVERSITY |
| Address |
Department of Anesthesiology
Rajarajeshwari medical College and hospital
RAJARAJESHWARI MEDICAL COLLEGE AND HOSPITAL, KENGERI HOBLI ,
Bangalore
KARNATAKA
560074
India |
| Phone |
9880574092 |
| Fax |
|
| Email |
drsowmyamj80@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR MADHURI G |
| Designation |
POSTGRADUATE, ANESTHESIOLOGY |
| Affiliation |
DR MGR UNIVERSITY |
| Address |
Department of Anesthesiology
Rajarajeshwari medical College and hospital
RAJARAJESHWARI MEDICAL COLLEGE AND HOSPITAL, KENGERI HOBLI ,
Bangalore
KARNATAKA
560074
India |
| Phone |
8861840505 |
| Fax |
|
| Email |
gmadhuri7914@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajarajeshwari medical College and hospital |
|
|
Primary Sponsor
|
| Name |
MADHURI G |
| Address |
Department of Anesthesiology
Raja rajeshwari medical College and hospital, Bangalore 560074 |
| 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 MADHURI |
Rajarajeshwari medical College and hospital |
Department of Anesthesiology
Raja rajeshwari medical College and hospital.
Bangalore
KARNATAKA |
8861840505
gmadhuri7914@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
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 |
Conventional Methods |
Conventional methods to prevent sore throat like lignocaine jelly, dexona 8mg IV prior to extubation will be used |
| Intervention |
Dextromethorphan lozenge |
Dextromethorphan lozenge with a dose of 5mg administered orally 45minutes prior to procedure to check for post operative sore throat |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Adult patients between 18-60 yr of age of either sex.
2.ASA status I, II ,III
Undergoing elective surgeries under general anesthesia with ETT tube in prone and supine position.
3.Patients posted for surgeries more than 1hr and lasting upto 6hrs
|
|
| ExclusionCriteria |
| Details |
1.Patients refusing to participate in the study
2.Patient posted for surgeries lasting more than 6hrs
3.Surgery involving the oral cavity, nasopharynx, larynx and neck regions.
4.History of preoperative sore throat, common cold, anticipated difficult airway.
5.Pregnant or lactating mothers.
6.Recent use of anti-inflammatory drugs
7.Allergic to study drug
8.On other centrally acting medications
9.Immune deficiencies
10.History of difficult intubation.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| •Assess the severity of post-operative sore throat in the study group |
To assess severity at 1 , 6 and 24hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| •To assess the degree of post-operative hoarseness of voice and cough |
To assess severity at 1 , 6 and 24 hours |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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 4 |
|
Date of First Enrollment (India)
|
30/06/2022 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Postoperative sore throat (POST) is one of the most common, undesirable and neglected complaint in patients following endotracheal intubation during general anaesthesia. We hypothesize that dextromethorphan in routine anti-tussive doses, would be effective to prevent POST thus improving patient recovery and satisfaction scores. |