Feasibility of Neostigmine for Intraoperative Neuromonitoring in Thyroid Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-10

Study Completion Date

2021-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Thyroid Diseases Surgical Injury Nerve Monitoring

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

a randomized controlled trial

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

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.

Study Groups

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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.

Group Type EXPERIMENTAL

Neostigmine

Intervention Type DRUG

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.

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.

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG