| CTRI Number |
CTRI/2025/08/093168 [Registered on: 18/08/2025] Trial Registered Prospectively |
| Last Modified On: |
18/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of dexamethasone and dexmedetomidine nebulization for reduction in incidence and severity of sore throat after laparoscopic gall bladder surgery in adult patients |
|
Scientific Title of Study
|
Comparative evaluation of nebulized dexamethasone with nebulized dexmedetomidine for reduction in incidence of post-operative sore throat in patients undergoing laparoscopic cholecystectomy under general anesthesia with endotracheal intubation |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ABHISHEK CHATTERJEE |
| Designation |
SENIOR CONSULTANT |
| Affiliation |
TATA MAIN HOSPITAL |
| Address |
Dept of Anaesthesiology,
MAIN OT, 2nd FLOOR, JGMH BLIOCK, TATA MAIN HOSPITAL, BC ROAD, BISTUPUR, JAMSHEDPUR
Purbi Singhbhum
JHARKHAND
831001
India |
| Phone |
7763807075 |
| Fax |
|
| Email |
dr.abhishek@tatasteel.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DONA LODH |
| Designation |
DNB RESIDENT |
| Affiliation |
TATA MAIN HOSPITAL |
| Address |
Dept of Anaesthesiology
Main OT, 2nd floor
JGMH block, Tata Main Hospital,
Bistupur
Jamshedpur
Purbi Singhbhum
JHARKHAND
831001
India |
| Phone |
7541943869 |
| Fax |
|
| Email |
dona6991@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ABHISHEK CHATTERJEE |
| Designation |
SENIOR CONSULTANT |
| Affiliation |
TATA MAIN HOSPITAL |
| Address |
Dept of Anaesthesiology
MAIN OT, 2nd FLOOR, JGMH BLIOCK, TATA MAIN HOSPITAL, BC ROAD, BISTUPUR, JAMSHEDPUR
Purbi Singhbhum
JHARKHAND
831001
India |
| Phone |
7763807075 |
| Fax |
|
| Email |
dr.abhishek@tatasteel.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ABHISHEK CHATTERJEE |
| Address |
TATA MAIN HOSPITAL, BC ROAD, BISTUPUR, JAMSHEDPUR, JHARKHAND |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 0 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
|
|
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 |
| Healthy Human Volunteers |
Healthy patients undergoing laparoscopic cholecystectomy under general anesthesia |
| Patients |
(1) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dexamethasone |
8mg nebulized Dexamethasone dilute to 5ml with normal saline |
| Intervention |
Dexmedetomidine |
nebulized Dexmedetomidine 50mcg diluted to 5ml with normal saline |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1
ASA 2
Scheduled for elective laparoscopic cholecystectomy surgery |
|
| ExclusionCriteria |
| Details |
ASA 3
ASA 4
history of allergy to study drugs
anticipated difficult airway
uncontrolled comorbid conditions |
|
|
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 |
| incidence and severity of postoperative sore throat |
2 hours, 6 hours, 12 hours, 24 hours after extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| incidence of hoarseness of voice, cough |
2 hours, 6 hours, 12 hours, 24 hours after extubation |
|
|
Target Sample Size
|
Total Sample Size="132"
Sample Size from India="132"
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)
|
02/09/2025 |
| 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="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
132 Patients fulfilling the inclusion criteria will be randomly allocated into three equal groups. Group S will receive 8mg nebulized dexamethasone. Group D will receive 50mcg nebulized dexmedetomidine and Group P will receive 5ml nebulized normal saline. The incidence and severity of postoperative sore throat along with incidence of hoarseness of voice and cough will be observed at four different time points after extubation |