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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04873531
Other study ID # 10-2021-12
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


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
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