Feasibility of Neostigmine for Intraoperative Neuromonitoring in Thyroid Surgery

Seoul National University

Status: Completed

Conditions: Thyroid Diseases; Surgical Injury; Nerve Monitoring

Treatments: Drug: Normal saline; Drug: Neostigmine

Study type: Interventional

Funder types: Other

Identifiers

NCT04873531

10-2021-12

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 19+ years old

Volunteers: No 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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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44 participants in 2 patient groups, including a placebo group

Neostigmine

Experimental group

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.

Treatment:

Drug: Neostigmine

Normal saline

Placebo Comparator group

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.

Treatment:

Drug: Normal saline