Clinical trial NCT02377882: The Optimal Dosage of Rocuronium for Intraoperative Neuromonitoring During Thyroid Surgery
Official title: The Optimal Dosage of Neuromuscular Blocking Agent for Intraoperative Neuromonitoring During Thyroid Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: THYROIDECTOMY
Keywords: Intra-operative neuromonitoring
Neuromuscular blocking agent
Rocuronium
Thyroid surgery
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2015-03-04
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who were planned to receive thyroidectomy

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.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of thyroid tumor

Exclusion Criteria:

* neuromuscular disease

Primary outcomes:
measure: The time to detect V1 and V2 signals
timeFrame: WITHIN 2 DAYS, follow up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Hospital
Study officials:
affiliation: Department of Anesthesiology, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan
name: I-Chen Lu, M.D.
role: STUDY_CHAIR
References:
citation: Dralle H, Sekulla C, Lorenz K, Brauckhoff M, Machens A; German IONM Study Group. Intraoperative monitoring of the recurrent laryngeal nerve in thyroid surgery. World J Surg. 2008 Jul;32(7):1358-66. doi: 10.1007/s00268-008-9483-2.
citation: Chan WF, Lo CY. Pitfalls of intraoperative neuromonitoring for predicting postoperative recurrent laryngeal nerve function during thyroidectomy. World J Surg. 2006 May;30(5):806-12. doi: 10.1007/s00268-005-0355-8.
citation: Chan WF, Lang BH, Lo CY. The role of intraoperative neuromonitoring of recurrent laryngeal nerve during thyroidectomy: a comparative study on 1000 nerves at risk. Surgery. 2006 Dec;140(6):866-72; discussion 872-3. doi: 10.1016/j.surg.2006.07.017. Epub 2006 Sep 18.