Feasibility of Neostigmine for Intraoperative Neuromonitoring in Thyroid Surgery

Thyroid Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04873531
• Other study ID #: 10-2021-12
• Status: Completed
• Phase: N/A
• Start date: May 10, 2021
• Est. completion date: August 31, 2021

Study information

• Verified date: March 2022
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: August 31, 2021
• Est. primary completion date: August 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Intraoperative Complications
• Nerve Monitoring
• Surgical Injury
• Thyroid Diseases

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul Metropolitan Government Seoul National University Boramae Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	SMG-SNU Boramae Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to recovery of cricothyroid muscle twitching	Time from the rocuronium administration to recovery of cricothyroid muscle twitching	perioperative
Secondary	amplitude of EMG for V1	micro-volts (uV), Electromyography amplitude of the vagus nerve before tumor manipulation	During surgery
Secondary	amplitude of EMG for R1	micro-volts (uV), Electromyography amplitude of the recurrent laryngeal nerve before tumor manipulation	During surgery
Secondary	amplitude of EMG for R2	micro-volts (uV), Electromyography amplitude of the recurrent laryngeal nerve after tumor removal	During surgery
Secondary	amplitude of EMG for V2	micro-volts (uV), Electromyography amplitude of the vagus nerve after tumor removal	During surgery
Secondary	number of patients with involuntary movements disrupting 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	During surgery