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Use of a new machine to prevent nerve injury during thyroid surgery

Role of intraoperative neuromonitoring in identification of external branch of superior laryngeal nerve during thyroidectomy operation - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/11/059854
Enrollment
30
Registered
2023-11-15
Start date
Unknown
Completion date
Unknown
Last updated
2023-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: D34- Benign neoplasm of thyroid gland Health Condition 2: O- Medical and Surgical Health Condition 3: O- Medical and Surgical Health Condition 4: X- New Technology

Interventions

Intervention1: Intraoperative Neuromonitoring: IONM is performed using the nerve integrity monitor (NIM-Response 3.0 System
Medtronic Xomed, Jacksonville, FL, USA) . The device is configured with an amplitude threshold of 100 µV and a stimulation intensity of 1mA. Surface electrodes integrated with an endotracheal tube wit
Medtronic Xomed, Jacksonville, FL, USA) are attached to the nerve integrity monitor. During intubation, the tube is placed between VCs under direct vision. A monopolar electrode with an interrupted s

Sponsors

Dr Sanjib Barman
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All patients within the age group between 20 and 50 years with thyroid swellings, nodular or cystic, benign or malignant, subjected to thyroidectomy will be included in the study

Exclusion criteria

Exclusion criteria: 1.Previous thyroid surgery or other surgery involving neck 2.Previous history of radiation to neck 3.Anaplastic carcinoma of thyroid 4.Patients with any preoperative vocal cord mobility disorder 5.Pregnancy and lactation 6.Bleeding diathesis, anemia, poor anesthetic risk or uncontrolled medical illness.

Design outcomes

Primary

MeasureTime frame
To evaluate the efficacy of intraoperative neuromonitoring in identification of external branch of superior laryngeal nerve during thyroidectomy operation in comparison to the standard visual identificationTimepoint: During operation, post operative day 1,5 and 15

Secondary

MeasureTime frame
To assess pitfalls in the use of nerve monitor during external branch of superior laryngeal nerve identification in thyroidectomy operation.Timepoint: During operation

Countries

India

Contacts

Public ContactDr Abhinandan Bhattacharjee

Silchar Medical College and Hospital

dr.abhinandan1@gmail.com9435072159

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026