| CTRI Number |
CTRI/2020/05/025203 [Registered on: 15/05/2020] Trial Registered Prospectively |
| Last Modified On: |
27/04/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare effect of intravenous Dexamethasone and Lidocaine to prevent postoperative sore throat in patients under G.A. |
|
Scientific Title of Study
|
A Comparison of intravenous Dexamethasone and Lidocaine for prevention of postoperative sore throat in patients undergoing surgery under G.A. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Satyajeet Singh |
| Designation |
PG Rseident |
| Affiliation |
Peoples college of medical sciences and research centre |
| Address |
Flat no.5, Sr. MIG, Peoples Campus , Bhanpur , Bhopal
Department of Anaesthesia, Peoples Hospital, PCMS & RC, Bhanpur, Bhopal
Bhopal
MADHYA PRADESH
462010
India |
| Phone |
8959257243 |
| Fax |
|
| Email |
satya_jeet97@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
KL Kishnani |
| Designation |
Associate Professor |
| Affiliation |
Peoples college of medical sciences and research centre |
| Address |
Department of Anaesthesia, Peoples Hospital, PCMS & RC, Bhanpur, Bhopal
Department of Anaesthesia, Peoples Hospital, PCMS & RC, Bhanpur, Bhopal
Bhopal
MADHYA PRADESH
462010
India |
| Phone |
9425604212 |
| Fax |
|
| Email |
drkishnani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
KL Kishnani |
| Designation |
Associate Professor |
| Affiliation |
Peoples college of medical sciences and research centre |
| Address |
Department of Anaesthesia, Peoples Hospital, PCMS & RC, Bhanpur, Bhopal
Department of Anaesthesia, Peoples Hospital, PCMS & RC, Bhanpur, Bhopal
Sagar
MADHYA PRADESH
462010
India |
| Phone |
9425604212 |
| Fax |
|
| Email |
drkishnani@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Satyajeet singh |
| Address |
Department of Anaesthesia, Peoples Hospital, PCMS & RC, Bhanpur, Bhopal |
| 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 |
| Satyajeet Singh |
Peoples Hospital |
Department of Anaesthesia, Peoples Hospital, PCMS & RC, Bhanpur, Bhopal
Bhopal
MADHYA PRADESH |
8959257243
satya_jeet97@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R498||Other voice and resonance disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexamethasone (8mg) & Lidocaine 2% (1.5mg /kg) |
To compare the effect of prophylactic use of intravenous,Dexamethsone and LIdocaine to prevent post operative sore throat in G.A. patients. |
| Comparator Agent |
Lidocaine 2% (1.5mg/kg) & Dexamethasone (8mg) |
To compare the effect of prophylactic use of intravenous,Dexamethsone and LIdocaine to prevent post operative sore throat in G.A. patients. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA Grade 1 & 2 .
2. Patients posted for surgery under general anaesthesia under department of anaesthesia in Peoples Hospital. |
|
| ExclusionCriteria |
| Details |
1. Smoker.
2. Those with preexisting cough , hoarsness or sore throat.
3. Vocal performer by occupation.
4. Patients with recent or recurrent respiratory tract infection risk factor for post operative aspiration.
5. Obese patients.
6. Pregnant patients.
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Dexamethasone (8mg) is better in preventing post operative sore throat than Lidocaine 2% (1.5 mg/kg). |
1 hour. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Dexamethasone (8mg) is better in preventing post operative sore throat than Lidocaine 2% (1.5 mg/kg). |
1 hour. |
|
|
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
20/05/2020 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The aim of this study is to compare the effect of prophylactic use of intravenous Dexamethsone and Lidocaine to prevent post operative sore throat in post general anaesthesia patients. |