| CTRI Number |
CTRI/2025/09/095097 [Registered on: 19/09/2025] Trial Registered Prospectively |
| Last Modified On: |
18/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to compare the effect of Dexamethasone and Dexmedetomidine in reducing pain after thyroid surgery when added to local anaesthesia. |
|
Scientific Title of Study
|
A prospective randomized double blind study to evaluate the effect of Dexamethasone 4 mg and Dexmedetomidine 1 microgram per kg as adjuvants to 0 point 2 percent Ropivacaine in bilateral superficial cervical plexus block for thyroid surgeries |
| 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 CHANDRASHEKAR M P |
| Designation |
RESIDENT DOCTOR |
| Affiliation |
RNT MEDICAL COLLEGE |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, RNT MEDICAL COLLEGE, UDAIPUR
DEPARTMENT OF ANAESTHESIOLOGY, RNT MEDICAL COLLEGE, UDAIPUR, RAJASTHAN 313001
Udaipur
RAJASTHAN
313001
India |
| Phone |
9743011373 |
| Fax |
|
| Email |
mpchandru1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr LALIT KUMAR RAIGER |
| Designation |
Senior Professor |
| Affiliation |
RNT Medical colllege |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, RNT MEDICAL COLLEGE, UDAIPUR, RAJASTHAN 313001
DEPARTMENT OF ANAESTHESIOLOGY, RNT MEDICAL COLLEGE, UDAIPUR, RAJASTHAN 313001
Udaipur
RAJASTHAN
313001
India |
| Phone |
9414352823 |
| Fax |
|
| Email |
drlalitkumar@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr LALIT KUMAR RAIGER |
| Designation |
Senior Professor |
| Affiliation |
RNT Medical colllege |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, RNT MEDICAL COLLEGE, UDAIPUR, RAJASTHAN 313001
DEPARTMENT OF ANAESTHESIOLOGY, RNT MEDICAL COLLEGE, UDAIPUR, RAJASTHAN 313001
Udaipur
RAJASTHAN
313001
India |
| Phone |
9414352823 |
| Fax |
|
| Email |
drlalitkumar@hotmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
RNT Medical College |
| Address |
M B Hospital, RNT Medical College, near chetak circle, Udaipur, Rajasthan 313001 |
| Type of Sponsor |
Government medical college |
|
|
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 Chandrashekar M P |
M B HOSPITAL |
DEPARTMENT OF ANAESTHESIOLOGY, RNT MEDICAL COLLEGE, UDAIPUR, RAJASTHAN
Udaipur
RAJASTHAN |
9743011373
mpchandru1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC RNT MEDICAL COLLEGE RESEARCHER AND CONTROLLER UDAIPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E079||Disorder of thyroid, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bilateral Superficial Cervical Plexus Block |
Using Inj Ropivacaine 0.2% with Inj Dexamathasone 4mg |
| Intervention |
Bilateral Superficial Cervical Plexus Block |
Using Inj Ropivacaine 0.2% with Inj Dexmeditomedine 1mcg/kg |
| Comparator Agent |
Bilateral superficial cervical plexus block |
Using Ropivacaine 0.2 % alone |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Elective thyroid surgeries under General Anaesthesia |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess duration of postoperative analgesia |
AT BASELINE 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24 HOURS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
I) To study the post-operative pain reduction, rescue analgesic requirement,
sedation in patients & patient satisfaction.
II) To determine the adverse effects, if any. |
AT BASELINE, 24HOURS, 1WEEKS, 2WEEKS |
|
|
Target Sample Size
|
Total Sample Size="105"
Sample Size from India="105"
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)
|
02/10/2025 |
| 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="1"
Months="0"
Days="0" |
|
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
|
The goal of our present study is to assess the analgesic efficacy of Ropivacaine (0.2%) alone or with Dexmedetomidine (1µg/kg) or with Dexamethasone (4mg), in three groups respectively in a double-blind fashion performed through bilateral superficial cervical plexus block (BSCPB) after completion of surgery, with regard to duration of analgesia, pain intensity scores (VAS), 24 hours postoperative tramadol requirements, and any complication after thyroidectomy. |