NCT03299621

Brief Summary

The evaluation of the anesthetic depth monitoring using PLE (Phase Lag Entropy) during propofol anesthesia

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

August 25, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 3, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

November 13, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2018

Completed
Last Updated

November 14, 2017

Status Verified

November 1, 2017

Enrollment Period

10 months

First QC Date

August 25, 2017

Last Update Submit

November 13, 2017

Conditions

Anesthesia, General

Outcome Measures

Primary Outcomes (1)

  • PLE (Phase Lag Entropy) value before and after intubation

    Investigators measure the PLE value at the time points that propofol target effect site concentration reach at 0, 2, 4, 5, 6 μg/ml, and the time points before and after intubation.

    at the time points that propofol target effect site concentration reach to 0, 2, 4, 5, 6 μg/ml, and the time points before and after intubation

Secondary Outcomes (4)

  • PLE value before and after the injection of muscle relaxant

    at 3 min after the injection of muscle relaxant, immediately after intubation

  • PLE value and BIS value at that time of induction and awakening

    at the time point of no-response to verbal command during induction (modified Observer's assessment of Alertness/Sedation scale (modified OAA/S scale) = 2, at the time point of response to verbal command during awakening (modified OAA/S scale = 3).

  • Bispectral index (BIS) value before and after intubation

    at the time points that propofol target effect site concentration reach to 0, 2, 4, 5, 6 μg/ml, and the time points before and after intubation

  • Band power (Gamma, Beta, Alpha, Theta, and Delta waves) before and after intubation

    at the time points that propofol target effect site concentration reach at 0, 2, 4, 5, 6 μg/ml, and the time points before and after intubation

Study Arms (2)

PLE (Phase Lag Entropy) monitoring

EXPERIMENTAL

Investigators monitor the change of PLE value using the sensor of PLEM™ during propofol anesthesia.

Device: PLE (Phase Lag Entropy)

Muscle relaxant injection

EXPERIMENTAL

Investigators monitor the change for PLE value using the sensor of PLEM™ before and after the injection of muscle relaxant.

Drug: Muscle Relaxant

Interventions

PLE (Phase Lag Entropy)DEVICE

Monitoring of PLE value using the monitoring of PLEM™ device during propofol anesthesia.

Also known as: PLEM™ (Inbody co., ltd)
PLE (Phase Lag Entropy) monitoring
Muscle RelaxantDRUG

Monitoring of PLE value using the monitoring of PLEM™ device before and after the injection of muscle relaxant that used for tracheal intubation.

Also known as: Muscle relaxant (rocuronium)
Muscle relaxant injection

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • The patients undergoing elective general anesthesia with American Society fo Anesthesiologist (ASA) physical status I or II (20-60 years)

You may not qualify if:

  • Patients with difficulty airway
  • Patients with cardiovascular disease
  • Patients with cerebrovascular disease
  • Patients with respiratory disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Korea University Anam Hospital

Seoul, Inchon-ro 8-gil 73, 02841, South Korea

RECRUITING

Korea University Anam Hospital

Seoul, South Korea

RECRUITING

Related Publications (1)

  • Shin HW, Kim HJ, Jang YK, You HS, Huh H, Choi YJ, Choi SU, Hong JS. Monitoring of anesthetic depth and EEG band power using phase lag entropy during propofol anesthesia. BMC Anesthesiol. 2020 Feb 26;20(1):49. doi: 10.1186/s12871-020-00964-5.

    PMID: 32102676DERIVED

MeSH Terms

Interventions

Rocuronium

Intervention Hierarchy (Ancestors)

AndrostanolsAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Hye-Won Shin, Ph.D.

    Korea University Anam Hospital, Seoul, Inchon-ro 8-gil 73, Seoul, Republic of Korea

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyun-Jung Kim, M.D.

CONTACT

821033859168k87876655@gmail.com

Hye-Won Shin, Ph.D.

CONTACT

821092735025drhwshin@naver.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Anesthesiology and Pain Medicine

Study Record Dates

First Submitted

August 25, 2017

First Posted

October 3, 2017

Study Start

November 13, 2017

Primary Completion

August 31, 2018

Study Completion

August 31, 2018

Last Updated

November 14, 2017

Record last verified: 2017-11

Locations

KR(2)