- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04873531
Feasibility of Neostigmine for Intraoperative Neuromonitoring in Thyroid Surgery
Feasibility of Neostigmine as a Reversal Agent of Neuromuscular Blockade for Intraoperative Neuromonitoring During Thyroid Surgery: a Prospective Randomized Controlled Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Seoul, Korea, Republic of, 07061
- Seoul Metropolitan Government Seoul National University Boramae Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Neostigmine
For the Neostigmine (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. |
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.
Other Names:
|
Placebo Comparator: Normal saline
For the Normal saline (NS) group, normal saline with a same volume of the N group will be administered just after tracheal intubation. Investigators evaluate the quality of signal of IONM during the surgery. |
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to recovery of cricothyroid muscle twitching
Time Frame: perioperative
|
Time from the rocuronium administration to recovery of cricothyroid muscle twitching
|
perioperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
amplitude of EMG for V1
Time Frame: During surgery
|
micro-volts (uV), Electromyography amplitude of the vagus nerve before tumor manipulation
|
During surgery
|
amplitude of EMG for R1
Time Frame: During surgery
|
micro-volts (uV), Electromyography amplitude of the recurrent laryngeal nerve before tumor manipulation
|
During surgery
|
amplitude of EMG for R2
Time Frame: During surgery
|
micro-volts (uV), Electromyography amplitude of the recurrent laryngeal nerve after tumor removal
|
During surgery
|
amplitude of EMG for V2
Time Frame: During surgery
|
micro-volts (uV), Electromyography amplitude of the vagus nerve after tumor removal
|
During surgery
|
number of patients with involuntary movements disrupting surgery
Time Frame: 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
|
During surgery
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jung-Man Lee, MD.PhD, SMG-SNU Boramae Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Endocrine System Diseases
- Thyroid Diseases
- Intraoperative Complications
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Agents
- Enzyme Inhibitors
- Cholinesterase Inhibitors
- Parasympathomimetics
- Neostigmine
Other Study ID Numbers
- 10-2021-12
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Thyroid Diseases
-
Aarhus University HospitalOdense University Hospital; University of AarhusEnrolling by invitationThyroid Cancer | Thyroid Nodule (Diagnosis)Denmark
-
AllerganCompletedHypothyroidism | Thyroid Disease | Euthyroid | Thyroid Gland | Thyroid HormonesUnited States
-
Wuhan UniversityRecruitingThyroid Carcinoma | Thyroid Nodule (Benign) | Ablation; RetinaChina
-
National Cancer Institute (NCI)TerminatedInsular Thyroid Cancer | Recurrent Thyroid Cancer | Stage IV Follicular Thyroid Cancer | Stage IV Papillary Thyroid Cancer | Anaplastic Thyroid Cancer | Stage III Follicular Thyroid Cancer | Stage III Papillary Thyroid CancerUnited States
-
Rigen BiotechRenJi Hospital; Tianjin Medical University Cancer Institute and Hospital; Guangdong... and other collaboratorsRecruitingThyroid Cancer | Thyroid NoduleChina
-
University of FloridaNational Cancer Institute (NCI)RecruitingThyroid Cancer | Thyroid NodulesUnited States
-
Inha University HospitalRecruitingThyroid Cancer | Thyroid NoduleKorea, Republic of
-
Shanghai 10th People's HospitalUnknown
-
Boston Medical CenterCompletedThyroid Neoplasms | Thyroid Cancer | Thyroid NoduleUnited States
-
University of Wisconsin, MadisonNational Cancer Institute (NCI); University of MichiganCompletedThyroid Cancer | Thyroid Nodule | Benign Thyroid NoduleUnited States
Clinical Trials on Neostigmine
-
Pontificia Universidade Catolica de Sao PauloNot yet recruitingNeuromuscular Blockade | Neuromuscular Blockade, ResidualBrazil
-
NorthShore University HealthSystemCompleted
-
Korea University Ansan HospitalNot yet recruitingCOVID-19 | General Anesthesia
-
Onze Lieve Vrouw HospitalCompletedRespiratory Muscles | ElectromyographyBelgium
-
Merck Sharp & Dohme LLCCompleted
-
Konkuk University Medical CenterNot yet recruitingStrabismus | Emergence Delirium | Pediatric ALL
-
Pontificia Universidade Catolica de Sao PauloNot yet recruitingNeuromuscular Blockade | Neuromuscular Block, Residual | Neuromuscular Block Prolonged
-
Alexandria UniversityKasr El Aini Hospital; Fayoum UniversityCompletedPost-Dural Puncture HeadacheEgypt
-
National Institutes of Health Clinical Center (CC)Completed
-
James J. Peters Veterans Affairs Medical CenterUnknownNeurogenic Bowel | Spinal Cord InjuryUnited States