NCT02000973

Brief Summary

The investigators designed a prospective, randomized, placebo-controlled study to determine whether thoracic epidural anesthesia(TEA) with different local anesthetics has different influences on the propofol dose during induction.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2013

Shorter than P25 for phase_4

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, 2013

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

November 22, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 4, 2013

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
3 months until next milestone

Results Posted

Study results publicly available

May 16, 2014

Completed
Last Updated

May 16, 2014

Status Verified

April 1, 2014

Enrollment Period

2 months

First QC Date

November 22, 2013

Results QC Date

March 6, 2014

Last Update Submit

April 20, 2014

Conditions

General AnesthesiaPropofol Target-controlled InfusionThoracic Epidural Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Propofol Effect-site Concentration

    The effect-site concentration of propofol when loss of consciousness during propofol target-controlled infusing(TCI) induction of anesthesia.

    Before starting anesthesia to finishing endotracheal intubation

Secondary Outcomes (3)

  • Mean Arterial Pressure

    Before starting anesthesia to finishing endotracheal intubation

  • Heart Rate

    Before starting anesthesia to finishing endotracheal intubation

  • Bispectral Index Score

    Before starting anesthesia to finishing endotracheal intubation

Study Arms (4)

Normal saline

PLACEBO COMPARATOR

General anesthesia combined with thoracic epidural 0.9% normal saline 8ml

Drug: Normal Saline

Lidocaine

EXPERIMENTAL

General anesthesia combined with thoracic epidural 1% lidocaine 8ml

Drug: Lidocaine

Bupivacaine

EXPERIMENTAL

General anesthesia combined with thoracic epidural 0.25% bupivacaine 8ml

Drug: Bupivacaine

Ropivacaine

EXPERIMENTAL

General anesthesia combined with thoracic epidural 0.3% ropivacaine 8ml

Drug: Ropivacaine

Interventions

LidocaineDRUG

General anesthesia combined with thoracic epidural 1% lidocaine

Lidocaine
BupivacaineDRUG

General anesthesia combined with thoracic epidural 0.25% bupivacaine

Bupivacaine
RopivacaineDRUG

General anesthesia combined with thoracic epidural 0.3% ropivacaine

Ropivacaine
Normal SalineDRUG

General anesthesia combined with thoracic epidural 0.9% normal saline

Normal saline

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Surgery for thoracotomies, BMI: 18-25 Kg/m2, American Society of Anesthesiologists(ASA) classification I or II.

You may not qualify if:

  • liver or kidney disease, alcohol dependence, take sedative recently, contraindications for epidural anesthesia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

LidocaineBupivacaineRopivacaineSaline Solution

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Results Point of Contact

Title
Jun Wang
Organization
First Hospital of China Medical University
wjun2000@hotmail.com
8602483283100

Study Officials

  • Jun Wang

    Dept. of Anesthesiology, First Hospital of China Medical University

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 22, 2013

First Posted

December 4, 2013

Study Start

November 1, 2013

Primary Completion

January 1, 2014

Study Completion

March 1, 2014

Last Updated

May 16, 2014

Results First Posted

May 16, 2014

Record last verified: 2014-04