The Optimal Dosage of Rocuronium for Intraoperative Neuromonitoring During Thyroid Surgery

Completed

• Conditions: THYROIDECTOMY

• Registration Number: NCT02377882
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

Brief Summary

The investigators tried to explore an alternative non-depolarizing muscle relaxant (rocuronium) and its optimal dosage to replace succinylcholine for IONM during thyroid surgery.Time frame of outcome measure was during 30 to 70min after rocuronium injection. Specific time points at which the will be assessed and for EMG signals will be presented.

Detailed Description

Recurrent laryngeal nerve (RLN) palsy is the most common and serious complication after thyroid surgery, and ranks among the leading reasons for medicolegal litigation of surgeons. Intraoperative neuromonitoring (IONM) are being applied to prevent RLN injury during thyroid surgery. IONM has been used as a means not only to localize and identify the RLN, but also to predict cord function and elucidate the surgical pitfalls during preparation of RLN.

Muscle relaxant is necessary for general anesthesia; it can facilitate tracheal intubation and stable conditions for surgery. However, the use of muscle relaxant might diminish the EMG response during IONM and interfere with the interpretation of IONM results. Eighty patients were randomized to receive one (group 1, n=40) or two (group 2, n=40) effective dose (ED95) of rocuronium to facilitate EMG endotracheal tube insertion. Evoked potentials were obtained per 5 minutes by stimulating vagus nerve from the time point of 30 to 70 minutes after administration of rocuronium. The magnitude of evoked potential at each time point and tracheal intubating condition were compared between groups. Accelerometry \[twitch (% TW)\] was used to monitor the quantitative degree of neuromuscular transmission. The aim of this study was to explore an alternative non-depolarizing muscle relaxant (Rocuronium) and its optimal dosage to replace succinylcholine for IONM. The ED95 of rocuronium is 0.3mg/kg and 2×ED95 is generally recommended as a standard intubation dosage.

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2009-12
• Study Completion: 2010-02
• Study First Submitted: 2010-07-08
• Status Verified: 2015-02
• Study First Submitted QC: 2015-02-26
• Last Update Submitted: 2015-02-26
• Study First Posted: 2015-03-04
• Last Update Posted: 2015-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Clinical diagnosis of thyroid tumor

Exclusion Criteria

• neuromuscular disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The time to detect V1 and V2 signals	WITHIN 2 DAYS, follow up to 6 months	V1 signal means an EMG signals obtained from the vagus nerve before identification of RLN.; V2 signal-The final testing of the vagus nerve EMG signals was performed after complete hemostasis of the operative field.; The amplitude (μV) of V1 and V2 signals and the correlated degree of neuromuscular transmission (% TW) were recorded and analyzed.

Trial Locations

Locations (1)

Kaohsiung Medical University Chung-Ho Hospital; 🇨🇳 Kaohsiung, Taiwan