Feasibility of Neostigmine for Intraoperative Neuromonitoring in Thyroid Surgery

Sponsor

Seoul National University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04873531

Collaborator

SMG-SNU Boramae Medical Center (Other)

Enrollment

Location

Arms

3.7

Actual Duration (Months)

11.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Thyroid Diseases Surgical Injury Nerve Monitoring	Drug: Neostigmine Drug: Normal saline	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

a randomized controlled triala randomized controlled trial

Masking:

Double (Participant, 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.

Primary Purpose:

Prevention

Official Title:

Feasibility of Neostigmine as a Reversal Agent of Neuromuscular Blockade for Intraoperative Neuromonitoring During Thyroid Surgery: a Prospective Randomized Controlled Study

Actual Study Start Date :

May 10, 2021

Actual Primary Completion Date :

Aug 23, 2021

Actual Study Completion Date :

Aug 31, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Time to recovery of cricothyroid muscle twitching [perioperative]
Time from the rocuronium administration to recovery of cricothyroid muscle twitching

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul Metropolitan Government Seoul National University Boramae Medical Center	Seoul		Korea, Republic of	07061

Sponsors and Collaborators

Seoul National University Hospital
SMG-SNU Boramae Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jung-Man Lee, Associate professor, Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT04873531

Other Study ID Numbers:

10-2021-12

First Posted:

May 5, 2021

Last Update Posted:

Mar 4, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Jung-Man Lee, Associate professor, Seoul National University Hospital

thyroid surgery

recurrent laryngeal nerve

neostigmine

intraoperative neuromonitoring

Additional relevant MeSH terms:

Thyroid Diseases

Intraoperative Complications

Neostigmine

Study Results

No Results Posted as of Mar 4, 2022