NCT03172078

Brief Summary

To evaluate the impacts of target-control infusion (TCI) and bispectral index (BIS) monitoring during advanced endoscopic procedure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2017

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 1, 2017

Completed
4 days until next milestone

Study Start

First participant enrolled

June 5, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 22, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 22, 2018

Completed
Last Updated

May 3, 2019

Status Verified

August 1, 2018

Enrollment Period

1.2 years

First QC Date

May 23, 2017

Last Update Submit

May 1, 2019

Conditions

Sedation

Keywords

advanced endoscopic procedureERCPEUStarget-controlled infusionsedationpropofol

Outcome Measures

Primary Outcomes (1)

  • propofol dose

    Total amount of propofol during the procedure

    during the endoscopic procedure

Secondary Outcomes (3)

  • sedation-related adverse events

    during the endoscopic procedure

  • Quality of sedation

    2 days

  • Recovery: open eye, conscious clear, discharge time

    within 2 hrs

Study Arms (2)

Target-control infusion without bispectral index monitoring

ACTIVE COMPARATOR

Target-control infusion (TCI) with propofol during advanced endoscopic procedure e.g. endoscopic Ultrasound (EUS), endoscopic retrograde cholangiopancreatogram (ERCP)

Procedure: advanced endoscopic procedure

Target-control infusion with bispectral index monitoring

ACTIVE COMPARATOR

Target-control infusion (TCI) with propofol and BIS monitoring during advanced endoscopic procedure e.g. endoscopic Ultrasound (EUS), endoscopic retrograde cholangiopancreatogram (ERCP)

Procedure: advanced endoscopic procedure

Interventions

advanced endoscopic procedurePROCEDURE

The advanced endoscopic procedure include endoscopic Ultrasound (EUS), endoscopic retrograde cholangiopancreatogram (ERCP), and other upper gastrointestinal endoscopy.

Target-control infusion with bispectral index monitoringTarget-control infusion without bispectral index monitoring

Eligibility Criteria

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

You may qualify if:

  • patients undergo advanced endoscopic procedure

You may not qualify if:

  • age less than 20 years, pregnant and lactating women, American Society of Anesthesiologists (ASA) class V, allergy to propofol, benzodiazepine, or opioid, and a requirement for general anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

Study Officials

  • LIN

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2017

First Posted

June 1, 2017

Study Start

June 5, 2017

Primary Completion

August 22, 2018

Study Completion

August 22, 2018

Last Updated

May 3, 2019

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)