The Optimal Dosage of Rocuronium for Intraoperative Neuromonitoring During Thyroid Surgery

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.

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Key information

Conditions

Thyroidectomy

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kaohsiung Medical University Chung-Ho Hospital

Kaohsiung City, 807, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Clinical diagnosis of thyroid tumor

Exclusion criteria

neuromuscular disease

Treatment and study plan

Primary outcomes

The time to detect V1 and V2 signals

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Other

Registry information

Official study title

The Optimal Dosage of Neuromuscular Blocking Agent for Intraoperative Neuromonitoring During Thyroid Surgery

Acronym: IONM

Important dates

Study start: 2009
Primary completion: 2009
Study completion: 2010
First posted: Mar 4, 2015
Registry last updated: Mar 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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