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Clinical Trials/NCT04873531
NCT04873531
Completed
Not Applicable

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

Seoul National University Hospital1 site in 1 country44 target enrollmentMay 10, 2021

Overview

Phase
Not Applicable
Intervention
Neostigmine
Conditions
Thyroid Diseases
Sponsor
Seoul National University Hospital
Enrollment
44
Locations
1
Primary Endpoint
Time to recovery of cricothyroid muscle twitching
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 10, 2021
End Date
August 31, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jung-Man Lee

Associate professor

Seoul National University Hospital

Eligibility Criteria

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)

Arms & Interventions

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.

Intervention: Neostigmine

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.

Intervention: Normal saline

Outcomes

Primary Outcomes

Time to recovery of cricothyroid muscle twitching

Time Frame: perioperative

Time from the rocuronium administration to recovery of cricothyroid muscle twitching

Secondary Outcomes

  • amplitude of EMG for V2(During surgery)
  • amplitude of EMG for R1(During surgery)
  • amplitude of EMG for V1(During surgery)
  • amplitude of EMG for R2(During surgery)
  • number of patients with involuntary movements disrupting surgery(During surgery)

Study Sites (1)

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