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

Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02377882
Collaborator
(none)
80
1
13
6.1

Study Details

Study Description

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 Intervention/Treatment Phase

    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 Design

    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 :
    Jan 1, 2009
    Actual Primary Completion Date :
    Dec 1, 2009
    Actual Study Completion Date :
    Feb 1, 2010

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Clinical diagnosis of thyroid tumor
    Exclusion Criteria:
    • neuromuscular disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kaohsiung Medical University Chung-Ho Hospital Kaohsiung Taiwan 807

    Sponsors and Collaborators

    • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Investigators

    • Study Chair: I-Chen Lu, M.D., Department of Anesthesiology, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    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:
    Mar 4, 2015
    Last Update Posted:
    Mar 4, 2015
    Last Verified:
    Feb 1, 2015
    Keywords provided by Koung-Shin Chu, visiting staff, Kaohsiung Medical University Chung-Ho Memorial Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 4, 2015