| CTRI Number |
CTRI/2026/01/101883 [Registered on: 23/01/2026] Trial Registered Prospectively |
| Last Modified On: |
01/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the effect of adding Dexmedetomidine to Total Intravenous Anaesthesia on the Quality of Recovery of patients undergoing Thyroid Surgery. |
|
Scientific Title of Study
|
Effect of Dexmedetomidine as an Adjunct to Total Intravenous Anaesthesia on the Quality of Recovery in patients undergoing Thyroid Surgery with Intraoperative Nerve Monitoring |
| 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 YAMINI ARORA |
| Designation |
DM resident |
| Affiliation |
AIIMS, New Delhi |
| Address |
Dept of Oncoanaesthesia and Palliative Medicine, Dr B R A Institute Rotary Cancer Hospital, AIIMS ,New Delhi
South
DELHI
110029
India |
| Phone |
9463458927 |
| Fax |
|
| Email |
dr.yaminianaesthesia@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Brajesh Kumar Ratre |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Dept of Oncoanaesthesia and Palliative Medicine, Dr B R A Institute Rotary Cancer Hospital, AIIMS ,New Delhi
South
DELHI
110029
India |
| Phone |
8696156799 |
| Fax |
|
| Email |
brajesh.ratre@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Brajesh Kumar Ratre |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Dept of Oncoanaesthesia and Palliative Medicine, Dr B R A Institute Rotary Cancer Hospital, AIIMS ,New Delhi
South
DELHI
110029
India |
| Phone |
8696156799 |
| Fax |
|
| Email |
brajesh.ratre@gmail.com |
|
|
Source of Monetary or Material Support
|
| ALL INDIA INSTITUTE OF MEDICAL SCIENCES (AIIMS),Ansari Nagar, New Delhi,110029,India |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences AIIMS New Delhi |
| Address |
Room no 242, Second floor,Dept. Of Onco-Anaesthesia & Palliative Medicine, Dr BRA IRCH, Ansari Nagar 110029, AIIMS, New Delhi, India. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 YAMINI ARORA |
All India Institute of Medical Sciences (AIIMS) ,New Delhi |
Dept. Of Onco-Anaesthesia
& Palliative Medicine, Dr BRA IRCH 2nd floor
South
DELHI |
9463458927
dr.yaminianaesthesia@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE, AIIMS ,New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C73||Malignant neoplasm of thyroid gland, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine |
Dexmedetomidine group patients will receive continuous infusion of 0.4 µg/kg/hr starting at induction of anaesthesia and will be stopped 1 hour before the anticipated end of surgery. |
| Comparator Agent |
Normal Saline |
Control group patients will receive an equal volume of Normal Saline (0.9% w/v) as a continuous infusion, administered identically to Group Dexmedetomidine |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA Physical status 1-2
2.Scheduled for thyroid surgeries with intraoperative nerve monitoring
3.Ability to understand and complete QoR40 questionnaire
4.Signed informed consent
|
|
| ExclusionCriteria |
| Details |
1. Pre-existing vocal cord dysfunction
2. ASAPhysical status 3-4
3. known allergy to propofol, fentanyl, dexmedetomidine
4. pre-existing cardiac conditions
5. morbid obesity
6. refusal to consent |
|
|
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 using QoR-40 questionnaire score in patients undergoing thyroid surgery with Intraoperative Neuromonitoring |
24 hours after surgery (on postoperative day 1) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the total intraoperative Propofol & Fentanyl consumption between the two groups. |
at extubation |
| To determine the time to eye opening or verbal response after discontinuation of anaesthetic agents. |
at end of surgery |
| To determine the Sedation Score using Ramsay Sedation Scale at 30 minutes & 60 minutes in the Post-Anaesthesia Care Unit (PACU). |
30 minutes & 60 mins after arrival in PACU |
| To determine the haemodynamic parameters as Heart Rate (HR) & Mean Arterial Pressure (MAP) at 1, 3,5,10 & 15 minutes post-intubation, every 15 minutes intraoperatively, & at extubation. |
Baseline(pre induction) 1,3,5,10,15 mins post intubation, every 15 minutes in intraoperative period, at extubation |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
01/06/2026 |
| 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 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
|
Despite the established practice of Intraoperative Neuromonitoring (IONM) in thyroid surgery and the documented benefits of Total Intravenous Anesthesia (TIVA) and dexmedetomidine independently in improving Quality of Recovery in thyroid surgeries, a significant gap in the literature persists regarding the specific impact of using dexmedetomidine as an adjunct to Propofol-based TIVA in this type of surgeries. This study is designed to evaluate the effect of dexmedetomidine as an adjunct to total intravenous anesthesia (TIVA) on the Quality of Recovery in patients undergoing thyroid surgery with IONM. The primary objective is to determine whether the known pharmacological benefits of dexmedetomidine can be translated into improved early quality of recovery (QoR-40 scores) along with reduced perioperative anaesthetic agents and opioid consumption without compromising the quality or reliability of the nerve monitoring signal. |