Neuromuscular Block and Anesthetic Depth Monitoring | NCT02575443

Studies
Neuromuscular Block and Anesthetic Depth Monitoring

NCT02575443

Sponsor

Seoul National University Bundang Hospital

Status

Completed

Last Update Posted

Oct 26, 2018Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Cholecystectomy, Laparoscopic

Interventions

Rocuronium (MB group)
Rocuronium (DB group)

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

Oct 2018

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

Sep 2015Actual

Primary Completion Date

Sep 2017Actual

Completion Date

Sep 2017Actual

First Submitted Date

Oct 6, 2015

First Submission Date that Met QC Criteria

Oct 9, 2015

First Posted Date

Oct 14, 2015Estimated

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

Oct 24, 2018

Last Update Posted Date

Oct 26, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hyo-Seok Na, Dr, Seoul National University Bundang HospitalPrincipal Investigator

Lead Sponsor

Seoul National University Bundang HospitalOTHER

Collaborators

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluated whether the depth of neuromuscular block may affect the unicon value of anesthetic depth monitoring system (ADMS).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Moderate block (MB) group	Experimental		Drug: Rocuronium (MB group)
Deep block (DB) group	Experimental		Drug: Rocuronium (DB group)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rocuronium (MB group)	Drug	Count of train-of-four: 1-2 Titration of rocuronium dose	Moderate block (MB) group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Total infused dose of propofol		At 1 min after the anesthesia is finished

Secondary Outcomes

Measure	Description	Time Frame
Electromyographic index presented on the anesthetic depth monitoring system		Through study completion, an average of 2 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Gall bladder disease
American Society of Anesthesiologist physical status 1 or 2

Exclusion Criteria:

Pregnancy
Body mass index < 16
Body mass index >30
Neuromuscular disease
Previous intraabdominal surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hyo-Seok Na	82, Gumi 173	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Bundang Hospital		Seongnam-si	Gyeonggi-do	463-707	South Korea

Intervention Browse Module

MeSH Terms

ID	Term
D000077123	Rocuronium

Ancestor Terms

ID	Term
D000732	Androstanols
D000731	Androstanes
D013256	Steroids
D000072473	Fused-Ring Compounds

Browse Leaves

Not provided

Browse Branches

Not provided