Nerve Monitoring, Surgical Injury, Thyroid Diseases
Conditions
Keywords
thyroid surgery, recurrent laryngeal nerve, neostigmine, intraoperative neuromonitoring
Brief summary
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.
Detailed description
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. This study will be performed as a randomized controlled trial with two groups (N group: neostigmine group and NS group: normal saline group). For the N group, neostigmine (0.03 mcg / kg) and glycopyrrolate with a 5:1 ratio will be administered just after tracheal intubation. For the NS group, normal saline with a same volume of the N group will be administered just after tracheal intubation. For all patients of two groups, investigators evaluate the quality of signal of IONM during the surgery.
Interventions
DRUGNeostigmine
For the N group, neostigmine (0.03 mcg / kg) and glycopyrrolate with a 5:1 ratio will be administered just after tracheal intubation. Investigators evaluate the quality of signal of IONM during the surgery.
DRUGNormal saline
For the NS group, neostigmine normal saline (0.09 cc/kg; the same volume of the group N) will be administered just after tracheal intubation. Investigators evaluate the quality of signal of IONM during the surgery.
Sponsors
SMG-SNU Boramae Medical Center
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
For participant, they will be blind to the group which they will be assigned. The surgeon, who will evaluate the quality of the signal, will be blinded to patient's group.
Intervention model description
a randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to recovery of cricothyroid muscle twitching | perioperative | Time from the rocuronium administration to recovery of cricothyroid muscle twitching |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| amplitude of EMG for V1 | During surgery | micro-volts (uV), Electromyography amplitude of the vagus nerve before tumor manipulation |
| amplitude of EMG for R1 | During surgery | micro-volts (uV), Electromyography amplitude of the recurrent laryngeal nerve before tumor manipulation |
| amplitude of EMG for R2 | During surgery | micro-volts (uV), Electromyography amplitude of the recurrent laryngeal nerve after tumor removal |
| amplitude of EMG for V2 | During surgery | micro-volts (uV), Electromyography amplitude of the vagus nerve after tumor removal |
| number of patients with involuntary movements disrupting surgery | During 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 |
Countries
South Korea
Outcome results
None listed