NCT02575443

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 6, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 14, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

October 26, 2018

Status Verified

October 1, 2018

Enrollment Period

2 years

First QC Date

October 6, 2015

Last Update Submit

October 24, 2018

Conditions

Cholecystectomy, Laparoscopic

Outcome Measures

Primary Outcomes (1)

  • Total infused dose of propofol

    At 1 min after the anesthesia is finished

Secondary Outcomes (1)

  • Electromyographic index presented on the anesthetic depth monitoring system

    Through study completion, an average of 2 hours

Study Arms (2)

Moderate block (MB) group

EXPERIMENTAL
Drug: Rocuronium (MB group)

Deep block (DB) group

EXPERIMENTAL
Drug: Rocuronium (DB group)

Interventions

Rocuronium (MB group)DRUG

Count of train-of-four: 1-2 Titration of rocuronium dose

Moderate block (MB) group
Rocuronium (DB group)DRUG

Post-tetanic count: 1-2 Titration of rocuronium dose

Deep block (DB) group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

MeSH Terms

Interventions

Rocuronium

Intervention Hierarchy (Ancestors)

AndrostanolsAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Hyo-Seok Na

    82, Gumi 173

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

October 6, 2015

First Posted

October 14, 2015

Study Start

September 1, 2015

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

October 26, 2018

Record last verified: 2018-10

Locations

KR(1)