Incidence of Postoperative Residual Neuromuscular Blockad... | NCT05760560

Studies
Incidence of Postoperative Residual Neuromuscular Blockade in the Era of Sugammadex

NCT05760560

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Apr 14, 2023Actual

Enrollment

52Estimated

Phase

Not provided

Conditions

Postoperative Residual Curarization

Interventions

Sugammadex

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

Apr 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 15, 2023Actual

Primary Completion Date

Aug 31, 2023Estimated

Completion Date

Aug 31, 2024Estimated

First Submitted Date

Feb 26, 2023

First Submission Date that Met QC Criteria

Feb 26, 2023

First Posted Date

Mar 8, 2023Actual

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

Apr 12, 2023

Last Update Posted Date

Apr 14, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Chang-Hoon Koo, Assistant professor, Seoul National University 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 52 patients will be included in this study. We will observe the incidence of postoperative residual neuromuscular blockade in patients receiving sugammadex.

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

52Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sugammadex	Drug	At the end of surgery, neuromucular blockade will be reversed with 2mg/kg or 4mg/kg sugammadex depending on the depth of neuromuscular blockade.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperative residual neuromuscular blockade	TOF ratio < 0.9	On the arrival of PACU

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing elective surgery under general anesthesia.
American Society of Anesthesiologists grade 1, 2, or 3.
Aged >18 years

Exclusion Criteria:

Refusal to participate in the study
Body Mass Index < 18.5 kg/m2 or > 35 kg/m2
History of neuromuscular disease.
History of allergy to neuromuscular blockade
Scheduled to transfer to the intensive care unit

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing elective surgery under general anesthesia will be screened and included in this study.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Chang-Hoon Koo	Contact	+821085098841		vollock9@gmail.com

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	Recruiting	Seongnam-si	Gyeonggi-do	13620	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39419348	Derived	Koo CH, Lee S, Yim S, Bae YK, Park I, Oh AY. Is quantitative neuromuscular monitoring mandatory after administration of the recommended dose of sugammadex? A prospective observational study. Anaesth Crit Care Pain Med. 2024 Dec;43(6):101445. doi: 10.1016/j.accpm.2024.101445. Epub 2024 Oct 16.

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D047408	gamma-Cyclodextrins
D003505	Cyclodextrins
D047028	Macrocyclic Compounds
D011083	Polycyclic Compounds