Feasibility of Neostigmine for Intraoperative Neuromonitoring in Thyroid Surgery

March 3, 2022 updated by: Jung-Man Lee, Seoul National University Hospital

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

Completed

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

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 07061
        • Seoul Metropolitan Government Seoul National University Boramae Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Drug: Neostigmine

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:
  • N group
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.
Drug: Normal 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.

Other Names:
  • NS group

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

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

SMG-SNU Boramae Medical Center

Investigators

  • Principal Investigator: Jung-Man Lee, MD.PhD, SMG-SNU Boramae Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2021

Primary Completion (Actual)

August 23, 2021

Study Completion (Actual)

August 31, 2021

Study Registration Dates

First Submitted

April 26, 2021

First Submitted That Met QC Criteria

April 29, 2021

First Posted (Actual)

May 5, 2021

Study Record Updates

Last Update Posted (Actual)

March 4, 2022

Last Update Submitted That Met QC Criteria

March 3, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-2021-12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

possible, If there would be reasonable explanation for sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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