NCT02927587

Brief Summary

Target-Controlled Infusion (TCI) of Propofol has been proved to be a safe agent for conscious sedation in flexible bronchoscopy (FB) .However, the target setting of "effect-site" concentration (Cet) of propofol is still unclear in the elderly population .The aim of this study was to compare two induction Cet of propofol in elderly patients undergoing flexible bronchoscopy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2015

Shorter than P25 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

November 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 7, 2016

Completed
Last Updated

October 7, 2016

Status Verified

October 1, 2016

Enrollment Period

4 months

First QC Date

October 3, 2016

Last Update Submit

October 6, 2016

Conditions

Adverse Effects

Keywords

TCIfiberoptic bronchoscopysedation

Outcome Measures

Primary Outcomes (1)

  • the adverse events(apnea , hypotension or hypertension, heart rate, oxygen saturation ,any cardiac event, cough score)

    Change from beginning of sedation to removal of bronchoscope

    1 and 2 hours

Study Arms (2)

The induction Cet of propofol 1

EXPERIMENTAL

The induction Cet of propofol was targeted at 1 ug/ml.

Drug: The induction Cet of propofol

The induction Cet of propofol 2

OTHER

The induction Cet of propofol was targeted at 2 ug/ml.

Drug: The induction Cet of propofol

Interventions

The induction Cet of propofolDRUG

The induction Cet of propofol was targeted respectively at 1 and 2 ug/ml.

Also known as: propofol
The induction Cet of propofol 1The induction Cet of propofol 2

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • body mass index \< 30 in males or \<28 in females
  • an ASA physical status I and III

You may not qualify if:

  • severe sleep apnoea syndrome (apnoea-hypopnea index \> 40)
  • bradycardia
  • hypotension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Hospital of Dalian Medical University

Dalian, Liaoning, 116000, China

Location

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2016

First Posted

October 7, 2016

Study Start

November 1, 2015

Primary Completion

March 1, 2016

Study Completion

April 1, 2016

Last Updated

October 7, 2016

Record last verified: 2016-10

Locations

CN(1)