Feasibility of Neostigmine for Intraoperative Neuromonitoring in Thyroid Surgery

NCT04873531 | Completed

• 1 other identifier: 10-2021-12
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid Diseases; Surgical Injury; Nerve Monitoring

Keywords

thyroid surgery; recurrent laryngeal nerve; neostigmine; intraoperative neuromonitoring

Outcome Measures

Primary Outcomes (1)

• Time to recovery of cricothyroid muscle twitching

  Time from the rocuronium administration to recovery of cricothyroid muscle twitching

  perioperative

Secondary Outcomes (5)

• amplitude of EMG for V1

  During surgery

• amplitude of EMG for R1

  During surgery

• amplitude of EMG for R2

  During surgery

• amplitude of EMG for V2

  During surgery

• number of patients with involuntary movements disrupting surgery

  During surgery

Study Arms (2)

Neostigmine

EXPERIMENTAL

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

Normal saline

PLACEBO COMPARATOR

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

Interventions

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.

Also known as: N group

Neostigmine

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.

Also known as: NS group

Normal saline

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• open thyroid surgery with intraoperative neuromonitoring

You may not qualify if:

• refusal to participate in the study
• rocuronium should not be used (e.g. renal dysfunction patient)

Sponsors & Collaborators

• Seoul National University Hospital: lead
• SMG-SNU Boramae Medical Center: collaborator

Study Sites (1)

Seoul Metropolitan Government Seoul National University Boramae Medical Center

Seoul, 07061, South Korea

Location

MeSH Terms

Conditions

Thyroid Diseases; Intraoperative Complications

Interventions

Neostigmine; Saline Solution

Condition Hierarchy (Ancestors)

Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Jung-Man Lee, MD.PhD

  SMG-SNU Boramae Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: a randomized controlled trial

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: May 5, 2021
• Study Start: May 10, 2021
• Primary Completion: August 23, 2021
• Study Completion: August 31, 2021
• Last Updated: March 4, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)