NCT02135016

Brief Summary

It is a prospective, randomized, placebo-controlled study to investigate the effect of TEA with different block level on propofol concentration during general anesthesia induction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2014

Shorter than P25 for phase_4

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

April 1, 2014

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

April 30, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 9, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
2 months until next milestone

Results Posted

Study results publicly available

August 29, 2014

Completed
Last Updated

August 29, 2014

Status Verified

August 1, 2014

Enrollment Period

3 months

First QC Date

April 30, 2014

Results QC Date

August 8, 2014

Last Update Submit

August 28, 2014

Conditions

Target Controlled Infusion (TCI)Thoracic Epidural AnesthesiaBlock LevelGastrointestinal Surgery

Keywords

effect-site concentrationpropofolthoracic epidural anesthesia

Outcome Measures

Primary Outcomes (1)

  • The Effect-site Concentration of Propofol

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

    The participants will be followed for the duration of anesthesia induction, an expected average of half an hour

Secondary Outcomes (4)

  • The Bispectral Index

    The participants will be followed for the duration of anesthesia induction, an expected average of half an hour

  • The Mean Blood Pressure

    The participants will be followed for the duration of anesthesia induction, an expected average of half an hour

  • The Heart Rate

    The participants will be followed for the duration of anesthesia induction, an expected average of half an hour

  • The Block Level of Epidural Anesthesia

    20 mins after epidural anesthesia

Study Arms (3)

1% lidocaine

EXPERIMENTAL

epidural anesthesia with 1% lidocaine 10ml before propofol TCI

Drug: 1% lidocaine

2% lidocaine

EXPERIMENTAL

epidural anesthesia with 2% lidocaine 5ml before propofol TCI

Drug: 2% lidocaine

0.9% normal saline

PLACEBO COMPARATOR

epidural anesthesia with 0.9% normal saline 5ml before propofol TCI

Drug: 0.9% normal saline

Interventions

1% lidocaineDRUG

epidural anesthesia with 1% lidocaine 10ml before propofol TCI

Also known as: A
1% lidocaine
2% lidocaineDRUG

epidural anesthesia with 2% lidocaine 5ml before propofol TCI

Also known as: B
2% lidocaine
0.9% normal salineDRUG

epidural anesthesia with 0.9% normal saline 5ml before propofol TCI

Also known as: C
0.9% normal saline

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • American Society of Anesthesiologists (ASA) I-II physical status,
  • aged 40-60 yr,
  • BMI 19-25 kg/m2,
  • undergoing elective gastrointestinal surgery

You may not qualify if:

  • patients with cardiovascular or neurological disease, drug or alcohol abuse and absolute contraindications for neuraxial blockade.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jun Wang

Shenyang, Liaoning, China

Location

MeSH Terms

Interventions

LidocaineSaline Solution

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Results Point of Contact

Title
Dr. Jun Wang
Organization
First Hospital of CMU
wjun2000@hotmail.com
8602483283100

Study Officials

  • Jun Wang, professor

    Dept. of Anesthesiology, First Affiliated Hospital of China Medical University

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

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

Study Record Dates

First Submitted

April 30, 2014

First Posted

May 9, 2014

Study Start

April 1, 2014

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

August 29, 2014

Results First Posted

August 29, 2014

Record last verified: 2014-08

Locations

CN(1)