| CTRI Number |
CTRI/2025/08/093695 [Registered on: 26/08/2025] Trial Registered Prospectively |
| Last Modified On: |
26/08/2025 |
| 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
|
Electrifying Precision: Testing a New Nerve Monitoring Method in Thyroid Operations |
|
Scientific Title of Study
|
Comparison of safety and efficacy of innovative thyroid cartilage needle electrodes with standard neural integrity monitor endotracheal tube for intra-operative nerve monitoring during thyroidectomy surgeries- a randomized clinical 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 |
Dr Rohit Bhondekar |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Nagpur |
| Address |
Room No 249 2nd Floor OPD AIIMS Nagpur Plot 02, Sector 20 AIIMS Nagpur MIHAN SEZ Nagpur Maharashtra
AIIMS Nagpur Plot 02, Sector 20 AIIMS Nagpur MIHAN SEZ Nagpur Maharashtra
Nagpur
MAHARASHTRA
441108
India |
| Phone |
9373397343 |
| Fax |
|
| Email |
aayushbhondekar@rediff.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandeep Dabhekar |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Nagpur |
| Address |
Room No 250, 2nd Floor, OPD, AIIMS Nagpur Plot 02, Sector 20 AIIMS Nagpur MIHAN SEZ Nagpur Maharashtra
AIIMS Nagpur Plot 02, Sector 20 AIIMS Nagpur MIHAN SEZ Nagpur Maharashtra
Nagpur
MAHARASHTRA
441108
India |
| Phone |
9860529979 |
| Fax |
|
| Email |
sandyent@aiimsnagpur.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rohit Bhondekar |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Nagpur |
| Address |
Room No 249, 2nd Floor, OPD AIIMS Nagpur Plot 02, Sector 20 AIIMS Nagpur MIHAN SEZ Nagpur Maharashtra
AIIMS Nagpur Plot 02, Sector 20 AIIMS Nagpur MIHAN SEZ Nagpur Maharashtra
Nagpur
MAHARASHTRA
441108
India |
| Phone |
9373397343 |
| Fax |
|
| Email |
aayushbhondekar@rediff.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Rohit Bhondekar |
| Address |
Room No 1201, 12th Floor PG Married Hostel AIIMS Nagpur Plot 02, Sector 20 AIIMS Nagpur MIHAN SEZ Nagpur Maharashtra |
| 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 Rohit Bhondekar |
AIIMS Nagpur |
AIIMS Nagpur MIHAN SEZ Nagpur Maharashtra
Nagpur
MAHARASHTRA |
9373397343
aayushbhondekar@rediff.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Nagpur Institutional Ethics Committee |
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 |
Neural Integrity Monitor Endotracheal Tube |
These are the conventional nerve monitor electrodes on the surface of endotracheal tubes |
| Intervention |
Thyroid Cartilage Needle Electrodes |
These are novel electrodes which will be placed onto thyroid cartilage for intra-operative nerve monitoring |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients scheduled to undergo thyroidectomy surgery.
2. Adults aged 18 years and above.
3. Patients willing to participate in the randomized clinical trial and provide informed consent.
4. Individuals with a willingness to engage in postoperative follow-up assessments to evaluate the long-term efficacy and safety of the novel electrode techniques compared to standard approaches.
5. Patients without significant abnormalities in vocal cord function or laryngeal anatomy that would preclude the use of IONM electrodes. |
|
| ExclusionCriteria |
| Details |
1. Patients with contraindications to thyroidectomy surgery.
2. Patients with pre-existing vocal cord dysfunction or laryngeal pathology.
3. Individuals enrolled in other clinical trials concurrently.
4. Pregnant women or those planning to become pregnant during the study period.
s. Patients with significant comorbidities that may affect surgical outcomes or intraoperative neuromonitoring, such as severe cardiopulmonary disease or neurological disorders.
6. Individuals enrolled in other clinical trials concurrently. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Efficacy & Safety profile, including intraoperative complications and postoperative adverse events.
|
Intraoperatively and at 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Incidence of recurrent laryngeal nerve (RLN) injury.
2. Signal quality & reliability comparison.
3. Patient-reported outcomes related to voice quality, swallowing function, & overall satisfaction.
|
At baseline, 3 & 6 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3 |
|
Date of First Enrollment (India)
|
09/09/2025 |
| 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="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
|
This randomized clinical trial will be conducted at a tertiary care hospital in central India, enrolling 60 patients with thyroid swelling who meet eligibility criteria. Participants will be randomized by SNOSE technique into two groups- intraoperative neuromonitoring using either thyroid cartilage needle electrodes or the standard neural integrity monitor endotracheal tube. Baseline demographics, intraoperative parameters, complications, and postoperative outcomes will be systematically recorded using a predesigned proforma, with follow-up at predetermined intervals. Statistical analysis will include t-tests, chi-square tests, and ANOVA with 95 percentage confidence interval, 90 percentage power, and alpha =0.05. Safety, efficacy, and cost-effectiveness of the two techniques will be evaluated, with monitoring and reporting of adverse events. Ethical approval obtained from the Institutional Ethics Committee, and informed consent will be secured from all participants. |