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NCT Number: NCT04873531

Feasibility of Neostigmine for Intraoperative Neuromonitoring in Thyroid Surgery

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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Key information

Conditions

Thyroid Diseases Endocrine System Diseases Intraoperative Complications Nerve Monitoring Pathologic Processes Pathological Conditions, Signs and Symptoms Surgical Injury

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul Metropolitan Government Seoul National University Boramae Medical Center

Seoul, 07061, South Korea

About this 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.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Neostigmine

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.

Other names: N group

normal saline

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.

Other names: NS group

Primary outcomes

  1. Time to recovery of cricothyroid muscle twitching

    Time frame: perioperative

    Time from the rocuronium administration to recovery of cricothyroid muscle twitching

Secondary outcomes

  1. amplitude of EMG for V1

    Time frame: During surgery

    micro-volts (uV), Electromyography amplitude of the vagus nerve before tumor manipulation

  2. amplitude of EMG for R1

    Time frame: During surgery

    micro-volts (uV), Electromyography amplitude of the recurrent laryngeal nerve before tumor manipulation

  3. amplitude of EMG for R2

    Time frame: During surgery

    micro-volts (uV), Electromyography amplitude of the recurrent laryngeal nerve after tumor removal

  4. amplitude of EMG for V2

    Time frame: During surgery

    micro-volts (uV), Electromyography amplitude of the vagus nerve after tumor removal

  5. 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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • SMG-SNU Boramae Medical Center

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 5, 2021
Registry last updated
Mar 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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