| CTRI Number |
CTRI/2025/07/091773 [Registered on: 25/07/2025] Trial Registered Prospectively |
| Last Modified On: |
25/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
The recovery in thyroid surgeries with two group of drugs |
|
Scientific Title of Study
|
The quality of recovery of opioid free anaesthesia with superficial cervical plexus block vs opioid based anaesthesia in thyroid and parathyroid surgeries-A prospective randomised controlled trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Devanshu Ranjan |
| Designation |
Post graduate student |
| Affiliation |
IGIMS, Patna |
| Address |
Department of anaesthesia, first floor, near OT complex, IGIMS, Patna 14
Patna
BIHAR
800014
India |
| Phone |
06200170587 |
| Fax |
|
| Email |
dewanshuranjan7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Akrity Singh |
| Designation |
Assistant Professor(Anesthesiology) |
| Affiliation |
IGIMS, Patna |
| Address |
Department of anaesthesia, first floor, near OT complex, IGIMS, Patna 14
Patna
BIHAR
800014
India |
| Phone |
9431664293 |
| Fax |
|
| Email |
drakrity_s@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Devanshu Ranjan |
| Designation |
Post graduate student |
| Affiliation |
IGIMS, Patna |
| Address |
Department of anaesthesia, first floor, near OT complex, IGIMS, Patna 14
Patna
BIHAR
800014
India |
| Phone |
06200170587 |
| Fax |
|
| Email |
dewanshuranjan7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government medical college, IGIMS, Sheikhpura, Patna- 800014, BIHAR, INDIA |
|
|
Primary Sponsor
|
| Name |
IGIMS |
| Address |
Department of anaesthesia, first floor, near OT complex, IGIMS, Patna 14 |
| 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 Dewanshu Ranjan |
IGIMS, Patna |
Department of Anaesthesia, 1st floor, Near OT complex, IGIMS, Sheikhpura
Patna
BIHAR |
06200170587
dewanshuranjan7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, IGIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E078||Other specified disorders of thyroid, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group B |
comparator- group B- patients receiving Injection remifentanil bolus for induction and its maintenance infusion |
| Intervention |
Group F
|
intervention - patients receiving ketamine, loading dose of dexmedetomidine followed by its maintenance infusion and B/L superficial cervical plexus block at 24 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients of ASA grade1, II
Patients scheduled for thyroid and parathyroid surgeries
|
|
| ExclusionCriteria |
| Details |
Age less than 18 years
Patients with a history of infection at the surgical site
Patients with coagulation dysfunction.
Patients who were chronically treated with beta-blockers with pulse rate less than 50/min
Patients with known history of drug allergy
Renal or hepatic impairment
Patient taking opioid for chronic pain
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| quality of recovery 15 score at 24 hours after surgery based on QOR 15 questionnaire between the 2 groups |
quality of recovery 15 score at 24 hours after surgery based on QOR 15 questionnaire between the 2 groups |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| QoR 15 at 48 hours , 72 hours PONV incidence and severity, length of hospital stay, pain score |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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)
|
17/10/2025 |
| 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="6"
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
|
The aim of this study is to evaluate the
quality of recovery between opioid free anaesthesia combined with superficial
cervical plexus block and opioid based anaesthesia in thyroid and parathyroid
surgeries.
Primary Objective- quality of recovery 15 score at 24 hours after
surgery based on QOR 15 questionnaire between the 2 groups
Secondary
Objective- QoR 15 at 48 hours ,
72 hours PONV incidence and severity, length of hospital stay, pain score . After obtaining informed written consent from patients, all patients of age 18-70 years posted for thyroid and parathyroid surgeries will be
randomly allotted into two groups: Group F and Group B. Randomisation will be
done using computer-generated sequence of random numbers in 1:1 ratio. Group F- (n=38) patients
receiving ketamine, loading dose of dexmedetomidine followed by its maintenance
infusion and B/L superficial cervical
plexus block
Group B- (n=38) patients
receiving Injection remifentanil bolus for induction and its maintenance infusion. Both groups compared for quality of recovery post operatively in terms of quality of recovery 15 questionnaire. |