| CTRI Number |
CTRI/2024/09/074318 [Registered on: 25/09/2024] Trial Registered Prospectively |
| Last Modified On: |
19/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing between ketamine nebulization and budesonide nebulization in decreasing the severity of sore throat postoperatively after endotracheal intubation under general anesthesia. |
|
Scientific Title of Study
|
A comparison of efficacy of preoperative ketamine nebulization versus budesonide nebulization in reducing the incidence and severity of sore throat postoperatively after general anaesthesia with endotracheal intubation :A prospective randomized double blind study. |
| 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 Meda Venkata Srinivas |
| Designation |
Assistant professor |
| Affiliation |
Government Medical College,Cuddapah |
| Address |
Department of anesthesia
Government medical college,
Kadapa-516002
Andhra pradesh
Cuddapah
ANDHRA PRADESH
516002
India |
| Phone |
9866301497 |
| Fax |
|
| Email |
srinivasmedadoc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Meda Venkata Srinivas |
| Designation |
Assistant professor |
| Affiliation |
Government Medical College,Cuddapah |
| Address |
Department of anesthesia
Government medical college,
Kadapa-516002
Andhra pradesh
Cuddapah
ANDHRA PRADESH
516002
India |
| Phone |
9866301497 |
| Fax |
|
| Email |
srinivasmedadoc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Meda Venkata Srinivas |
| Designation |
Assistant professor |
| Affiliation |
Government Medical College,Cuddapah |
| Address |
Department of anesthesia
Government medical college,
Kadapa-516002
Andhra pradesh
Cuddapah
ANDHRA PRADESH
516002
India |
| Phone |
9866301497 |
| Fax |
|
| Email |
srinivasmedadoc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anesthesiology,
Government medical college,
Kadapa |
|
|
Primary Sponsor
|
| Name |
Dr Sunil Chiruvella |
| Address |
department of anesthesiology,
Government medical college,
Kadapa |
| 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 Meda Venkata Srinivas |
Government General Hospital |
Government general hospital,
Puttlampalli,
Kadapa,
Andhra pradesh
Cuddapah
ANDHRA PRADESH |
9866301497
srinivasmedadoc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe,Government Medical College,Kadapa, |
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 |
budesonide |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA1 & ASA2 physical status patients aged between 18 to 65yrs admitted for elective surgery under general anaesthesia with endotracheal intubation with modified mallampatti score(MMP) I &II
2.Patients undergoing surgeries lasting less than 3hrs duration were selected for the study |
|
| ExclusionCriteria |
| Details |
1.Patients with history of sore throat.
2.Patients on long term anti-inflammatory analgesic medications.
3.Patients who have undergone insertion of devices which stimulate oral cavity, larynx, pharynx like nasogastric tube, endoscopic nasobiliary drainage tube.
|
|
|
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 |
| Primary outcome assessed was incidence and severity of post operative sore throat(POST). |
0 hour,,4 hour,8 hour,12 hour,24 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of post operative hoarseness and cough |
0,4,8,12,24 hours |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
30/09/2024 |
| 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="3"
Days="5" |
|
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
|
Various drugs have been compared to study their effectiveness in decreasing the incidence and severity of post operative sore throat(POST) in patients undergoing endotracheal intubation under general anesthesia .in this randomized double blind study, 100 patients were randomly divided into two groups group K (50) and group B (50) who will receive 2ml of 100 mg ketamine with 3ml of saline nebulization and 2ml of 0.5 mg budesonide solution with 3ml saline nebulisation .Budesonide is inhaled steroid that has decreases inflammation of airways .the main aim of the study is to compare between the two study drugs which decreased the incidence and severity of POST. Post operative hoareseness and cough between the two study drugs will be compared.
|