Low-dose Rocuronium Effect Neural Monitoring in Thyroid Surgery

NCT04230915 | Unknown

• 1 other identifier: BakirkoySadiKonuk -2019/154
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Intraoperative Neuromonitoring (IONM) was started to be used by surgeons to help prevent laryngeal nerve (RLN) damage during thyroid and parathyroid operations. IONM can be used to localize and identify RLN intraoperatively, to evaluate vocal function after thyroid resection, and to explain the mechanism of RLN injury. However, an important problem in the routine use of IONM is the effect of neuromuscular blocking agents (NMBAs). The use of NMBAs in general anesthesia is essential to provide clinically acceptable tracheal intubation conditions and to prevent laryngeal trauma. However, NMBAs may be the potential cause of a false-negative response during the IONM. Randolph et al. proposed short-acting 1-2 mg/kg succinylcholine for enough relaxation and the ease of electromyographic (EMG) endotracheal tube intubation during the IONM. However, succinylcholine, a depolarizing NMBA, is associated with various adverse effects such as cardiac arrhythmia, hyperkalemia, and malignant hyperthermia. Nondepolarizing NMBAs are widely used by most anesthesiologists due to their safe effects, but to the best our knowledge, there is no very short-acting nondepolarizing NMBA. This deficiency creates a problem because the dose and the time point of nerve stimulation are critical for a successful IONM. However, some studies have reported the feasibility of IONM following the administration of nondepolarizing NMBAs during a thyroid operation. Rocuronium is a short-acting and nondepolarizing NMBA type which is widely used for induction in general anesthesia. Although 0.6 mg/kg rocuronium is recommended for standard intubation dose, the ease of intubation can also be provided with 0.3 mg/kg rocuronium or 1.5 mg/kg succinylcholine. Therefore, the present study was designed to compare the effects of IONM with low and standard rocuronium doses in the induction of general anesthesia.

Conditions

Thyroid

Keywords

Intraoperative nerve monitoring; Train of four (TOF); Rocuronium; Operation Time

Outcome Measures

Primary Outcomes (1)

• Nerve signal detection time

  Variation of nerve signal detection time with dose of rocuronium

  Duration of surgery, up to 3 hours

Secondary Outcomes (1)

• Operation time

  Duration of surgery, up to 3 hours

Study Arms (2)

Low Dose Rocuronium

ACTIVE COMPARATOR

This group patients will determine as those who were administered 0.3 mg/kg rocuronium

Other: Intraoperative nerve monitoring

Strandart Dose Rocuronium

NO INTERVENTION

This group patients will determine as those who were administered 0.6 mg/kg rocuronium

Interventions

Intraoperative nerve monitoring OTHER

This group will determine as those who were administered 0.3 mg/kg rocuronium,

Low Dose Rocuronium

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical and radiological diagnosis of nodular or multinodular goiter
• Clinical, radiological and pathologicllay diagnosed thyroid cancer
• Must be able to speak( for voice recording)

You may not qualify if:

• Pregnancy
• Previous thyroid surgery
• Previous laryngeal surgery
• Professional voice users( e.g. singers)

Sponsors & Collaborators

• Bakirkoy Dr. Sadi Konuk Research and Training Hospital: lead

Study Sites (1)

Bakırkoy Sadi Konuk Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Thyroid Diseases

Interventions

Intraoperative Neurophysiological Monitoring

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Monitoring, Intraoperative; Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis; Neurophysiological Monitoring; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2019
• First Posted: January 18, 2020
• Study Start: February 1, 2020
• Primary Completion: April 29, 2020
• Study Completion: April 29, 2020
• Last Updated: January 18, 2020

Record last verified: 2020-01

Locations

TU (1)