Trial intelligence / Profile preview

Effects of TEA with different local anesthetics on propofol induction

NCT02000973Phase 4

Key facts

Status
Completed
Start
Nov 2013
Primary completion
Jan 2014
Sponsor
First Hospital of China Medical University
Modality
Orthosteric Ligands
01

Overview

Phase 4, randomised, double-blind trial of lidocaine, bupivacaine and ropivacaine (4 arms), sponsored by First Hospital of China Medical University. Primary endpoint: Propofol Effect-site Concentration. Started Nov 2013; status: completed.

02

Design

4 arms
Study design
RandomizedDouble-blind
  • Normal saline

    Thoracic epidural 0.9% normal saline + General anesthesia

  • Lidocaine

    Thoracic epidural 1% lidocaine + General anesthesia

  • Bupivacaine

    Thoracic epidural 0.25% bupivacaine + General anesthesia

  • Ropivacaine

    Thoracic epidural 0.3% ropivacaine + General anesthesia

03

Who it enrols

Patients undergoing thoracotomies with ASA classification I or II and BMI 18-25 kg/m2.

04

Endpoints

Primary

  • Propofol Effect-site Concentration

Secondary

  • Mean Arterial Pressure

  • Heart Rate

  • Bispectral Index Score

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