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Feasibility of Neostigmine for Intraoperative Neuromonitoring in Thyroid Surgery

Primary Purpose

Thyroid Diseases, Surgical Injury, Nerve Monitoring

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Neostigmine
Normal saline
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Thyroid Diseases focused on measuring thyroid surgery, recurrent laryngeal nerve, neostigmine, intraoperative neuromonitoring

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Seoul Metropolitan Government Seoul National University Boramae Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Neostigmine

Normal saline

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Time to recovery of cricothyroid muscle twitching
Time from the rocuronium administration to recovery of cricothyroid muscle twitching

Secondary Outcome Measures

amplitude of EMG for V1
micro-volts (uV), Electromyography amplitude of the vagus nerve before tumor manipulation
amplitude of EMG for R1
micro-volts (uV), Electromyography amplitude of the recurrent laryngeal nerve before tumor manipulation
amplitude of EMG for R2
micro-volts (uV), Electromyography amplitude of the recurrent laryngeal nerve after tumor removal
amplitude of EMG for V2
micro-volts (uV), Electromyography amplitude of the vagus nerve after tumor removal
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

Full Information

First Posted
April 26, 2021
Last Updated
March 3, 2022
Sponsor
Seoul National University Hospital
Collaborators
SMG-SNU Boramae Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04873531
Brief Title
Feasibility of Neostigmine for Intraoperative Neuromonitoring in Thyroid Surgery
Official Title
Feasibility of Neostigmine as a Reversal Agent of Neuromuscular Blockade for Intraoperative Neuromonitoring During Thyroid Surgery: a Prospective Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
May 10, 2021 (Actual)
Primary Completion Date
August 23, 2021 (Actual)
Study Completion Date
August 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
SMG-SNU Boramae Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Diseases, Surgical Injury, Nerve Monitoring
Keywords
thyroid surgery, recurrent laryngeal nerve, neostigmine, intraoperative neuromonitoring

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
a randomized controlled trial
Masking
ParticipantInvestigator
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.
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neostigmine
Arm Type
Experimental
Arm Description
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.
Arm Title
Normal saline
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Neostigmine
Other Intervention Name(s)
N group
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Normal saline
Other Intervention Name(s)
NS group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time to recovery of cricothyroid muscle twitching
Description
Time from the rocuronium administration to recovery of cricothyroid muscle twitching
Time Frame
perioperative
Secondary Outcome Measure Information:
Title
amplitude of EMG for V1
Description
micro-volts (uV), Electromyography amplitude of the vagus nerve before tumor manipulation
Time Frame
During surgery
Title
amplitude of EMG for R1
Description
micro-volts (uV), Electromyography amplitude of the recurrent laryngeal nerve before tumor manipulation
Time Frame
During surgery
Title
amplitude of EMG for R2
Description
micro-volts (uV), Electromyography amplitude of the recurrent laryngeal nerve after tumor removal
Time Frame
During surgery
Title
amplitude of EMG for V2
Description
micro-volts (uV), Electromyography amplitude of the vagus nerve after tumor removal
Time Frame
During surgery
Title
number of patients with involuntary movements disrupting surgery
Description
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
Time Frame
During surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jung-Man Lee, MD.PhD
Organizational Affiliation
SMG-SNU Boramae Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul Metropolitan Government Seoul National University Boramae Medical Center
City
Seoul
ZIP/Postal Code
07061
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
possible, If there would be reasonable explanation for sharing

Learn more about this trial

Feasibility of Neostigmine for Intraoperative Neuromonitoring in Thyroid Surgery

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