Continuuous intraoperative neuromonitoring during neck surgery - a prospective, randomized trial

Continuuous intraoperative neuromonitoring during neck surgery - a prospective, randomized trial - IKONA CIONM

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00000447

Enrollment

100

Registered

2010-06-21

Start date

2010-07-01

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

E04 C73

Interventions

Group 1: standard elektrode V3, Inomed GmbH Group 2: newly developed stimulation electrode IKS-1 ("Saxophon"-Elektrode)

Eligibility

Sex/Gender

All

Age

21 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. planned, elective neck surgery 2. ability of the patient to give informed consent

Exclusion criteria

Exclusion criteria: 1. Preexisting palsy of the recurrent laryngeal nerve 2. Patients suffering from severe cardiac arrhythmia (tachycardic/ bradycardic heart rhythm with hemodynamic instability) 3. Patients with a cardiac pacemaker 4. Pregnancy/ breast feeding mums/patients 5. Missing informed consent/ Patient is unable to provide informed consent

Design outcomes

Primary

Measure	Time frame
Safety and effectiveness of the new svagus nerve stimulation electrode	—

Secondary

Measure	Time frame
Reduction of clinical complications in thyroid surgery by continuous interapoerative neuromonitoring (CIONM)	—

Countries

Germany

Contacts

Public ContactWolfram Lamadé

Abteilung für Allgemein- und Viszeralchirurgie, Robert-Bosch-Krankenhaus Stuttgart

wolfram.lamade@rbk.de0711 8101 5923

Outcome results

None listed

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