Feasibility of Neostigmine for Intraoperative Neuromonitoring in Thyroid Surgery

Not Applicable

Completed

• Conditions: Thyroid Diseases; Nerve Monitoring; Surgical Injury
• Interventions: Drug: Normal saline; Drug: Neostigmine

• Registration Number: NCT04873531
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study First Submitted: 2021-04-26
• Study First Submitted QC: 2021-04-29
• Study First Posted: 2021-05-05
• Study Start: 2021-05-10
• Primary Completion: 2021-08-23
• Study Completion: 2021-08-31
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-03
• Last Update Posted: 2022-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal saline	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.
Neostigmine	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.

Primary Outcome Measures

Name	Time	Method
Time to recovery of cricothyroid muscle twitching	perioperative	Time from the rocuronium administration to recovery of cricothyroid muscle twitching

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul Metropolitan Government Seoul National University Boramae Medical Center; 🇰🇷 Seoul, Korea, Republic of