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The Optimal Dosage of Rocuronium for Intraoperative Neuromonitoring During Thyroid Surgery (IONM)

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ClinicalTrials.gov Identifier: NCT02377882
Recruitment Status : Completed
First Posted : March 4, 2015
Last Update Posted : March 4, 2015
Sponsor:
Information provided by (Responsible Party):
Koung-Shin Chu, 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.

Condition or disease
THYROIDECTOMY

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.

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Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Optimal Dosage of Neuromuscular Blocking Agent for Intraoperative Neuromonitoring During Thyroid Surgery
Study Start Date : January 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Diseases
Drug Information available for: Thyroid




Primary Outcome Measures :
  1. 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.




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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who were planned to receive thyroidectomy
Criteria

Inclusion Criteria:

  • Clinical diagnosis of thyroid tumor

Exclusion Criteria:

  • neuromuscular disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02377882


Locations
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Taiwan
Kaohsiung Medical University Chung-Ho Hospital
Kaohsiung, Taiwan, 807
Sponsors and Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital
Investigators
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Study Chair: I-Chen Lu, M.D. Department of Anesthesiology, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan
Publications:
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Responsible Party: Koung-Shin Chu, visiting staff, Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier: NCT02377882    
Other Study ID Numbers: KMUH-IRB-980170
First Posted: March 4, 2015    Key Record Dates
Last Update Posted: March 4, 2015
Last Verified: February 2015
Keywords provided by Koung-Shin Chu, Kaohsiung Medical University Chung-Ho Memorial Hospital:
Intra-operative neuromonitoring
Neuromuscular blocking agent
Rocuronium
Thyroid surgery
Additional relevant MeSH terms:
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Thyroid Diseases
Endocrine System Diseases