Thyroid Diseases Clinical Trial
Official title:
Feasibility of Neostigmine as a Reversal Agent of Neuromuscular Blockade for Intraoperative Neuromonitoring During Thyroid Surgery: a Prospective Randomized Controlled Study
NCT number | NCT04873531 |
Other study ID # | 10-2021-12 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 10, 2021 |
Est. completion date | August 31, 2021 |
Verified date | March 2022 |
Source | Seoul National University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
For successful intraoperative neuromonitoring (IONM), adequate reversal of neuromuscular blocking agent is a prerequisite in thyroid surgery with . The aim of this study is to investigate the feasibility of neostigmine just after tracheal intubation on the IONM in thyroid surgery.
Status | Completed |
Enrollment | 44 |
Est. completion date | August 31, 2021 |
Est. primary completion date | August 23, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility | Inclusion Criteria: - open thyroid surgery with intraoperative neuromonitoring Exclusion Criteria: - refusal to participate in the study - rocuronium should not be used (e.g. renal dysfunction patient) |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul Metropolitan Government Seoul National University Boramae Medical Center | Seoul |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital | SMG-SNU Boramae Medical Center |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to recovery of cricothyroid muscle twitching | Time from the rocuronium administration to recovery of cricothyroid muscle twitching | perioperative | |
Secondary | amplitude of EMG for V1 | micro-volts (uV), Electromyography amplitude of the vagus nerve before tumor manipulation | During surgery | |
Secondary | amplitude of EMG for R1 | micro-volts (uV), Electromyography amplitude of the recurrent laryngeal nerve before tumor manipulation | During surgery | |
Secondary | amplitude of EMG for R2 | micro-volts (uV), Electromyography amplitude of the recurrent laryngeal nerve after tumor removal | During surgery | |
Secondary | amplitude of EMG for V2 | micro-volts (uV), Electromyography amplitude of the vagus nerve after tumor removal | During surgery | |
Secondary | number of patients with involuntary movements disrupting surgery | number, number of patients who move involuntarily during surgery, which disrupt and pause the surgery to prevent harmful events, such as tracheal injuries by a sharp surgical devices during the surgery | During surgery |
Status | Clinical Trial | Phase | |
---|---|---|---|
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