Low-dose Neostigmine at TOF Ratio of 0.7 Improves Neuromu... | NCT06745492

Studies
Low-dose Neostigmine at TOF Ratio of 0.7 Improves Neuromuscular Recovery

NCT06745492

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Dec 20, 2024Actual

Enrollment

59Actual

Phase

Not provided

Conditions

Recovery Time

Interventions

Neostigmine + Glycopyrrolate

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2022Actual

Primary Completion Date

Aug 20, 2023Actual

Completion Date

Aug 25, 2023Actual

First Submitted Date

Dec 17, 2024

First Submission Date that Met QC Criteria

Dec 17, 2024

First Posted Date

Dec 20, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 17, 2024

Last Update Posted Date

Dec 20, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Chang-Hoon Koo, Professor, Seoul National University Bundang HospitalPrincipal Investigator

Lead Sponsor

Seoul National University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is a prospective observational study. A total of 54 patients were included in this study. We observed the time from neostigmine administration to TOF ratio of 1.0.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

59Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Neostigmine + Glycopyrrolate	Drug	a 20 mcg/kg of neostigmine and 4 mcg/kg of glycopyrrolate were administered at a TOF ratio of 0.7.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Recovery time	Time from neostigmine administration to TOF ratio of 1.0	During surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing elective thyroid surgery under general anesthesia
a body mass index of 18.5-25 kg/m2
Age ≥ 20

Exclusion Criteria:

Refused to participate
history of hypersensitivity to acetylcholinesterase inhibitor
neuromuscular disease
hepatic or renal dysfunction

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing elective thyroid surgery under general anesthesia were screened and included in this study

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Chang-Hoon Koo	Seoul National University Bundang Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Bundang Hospital		Seongnam			South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009388	Neostigmine
D006024	Glycopyrrolate

Ancestor Terms

ID	Term
D050338	Phenylammonium Compounds
D000644	Quaternary Ammonium Compounds
D000588	Amines
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided