The Effect of Thoracic Epidural Anesthesia With Different Block Level on Propofol Induction

Phase 4

Completed

• Conditions: Block Level; Gastrointestinal Surgery; Target Controlled Infusion (TCI); Thoracic Epidural Anesthesia
• Interventions: Drug: 1% lidocaine; Drug: 0.9% normal saline; Drug: 2% lidocaine

• Registration Number: NCT02135016
• Lead Sponsor: First Hospital of China Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-30
• Study First Submitted QC: 2014-05-07
• Study First Posted: 2014-05-09
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2014-08
• Results First Submitted: 2014-08-08
• Results First Submitted QC: 2014-08-28
• Last Update Submitted: 2014-08-28
• Results First Posted: 2014-08-29
• Last Update Posted: 2014-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1% lidocaine	1% lidocaine	epidural anesthesia with 1% lidocaine 10ml before propofol TCI
0.9% normal saline	0.9% normal saline	epidural anesthesia with 0.9% normal saline 5ml before propofol TCI
2% lidocaine	2% lidocaine	epidural anesthesia with 2% lidocaine 5ml before propofol TCI

Primary Outcome Measures

Name	Time	Method
The Effect-site Concentration of Propofol	The participants will be followed for the duration of anesthesia induction, an expected average of half an hour	The effect-site concentration of propofol when loss of consciousness during propofol target-controlled infusing(TCI) induction of anesthesia.

Secondary Outcome Measures

Name	Time	Method
The Bispectral Index	The participants will be followed for the duration of anesthesia induction, an expected average of half an hour	The bispectral index (BIS) of each patient will be recorded at four different time points,as follows, baseline(the awake phase before epidural anesthesia),10 mins after epidural anesthesia, 20 mins after epidural anesthesia, loss of consciousness(when the participants are lost eyelash reflex during propofol TCI induction of anesthesia). BIS values varies from 0 to 100(0, no cerebral activity; 40 to 60, general anesthesia; 60 to 85, sedated; 85 to 100, awake).
The Mean Blood Pressure	The participants will be followed for the duration of anesthesia induction, an expected average of half an hour	The mean arterial pressure of each patient will be recorded at four different time points, as follows, baseline(the awake phase before epidural anesthesia), 10 mins after epidural anesthesia, 20 mins after epidural anesthesia, loss of consciousness(when the participants are lost eyelash reflex during propofol TCI induction of anesthesia).
The Heart Rate	The participants will be followed for the duration of anesthesia induction, an expected average of half an hour	The heart rate of each patient will be recorded at three different four points, as follows, baseline(the awake phase before epidural anesthesia), 10mins after epidural anesthesia, 20 mins after epidural anesthesia, loss of consciousness(when the participants are lost eyelash reflex during propofol TCI induction of anesthesia).
The Block Level of Epidural Anesthesia	20 mins after epidural anesthesia	The block level 20mins after epidural anesthesia and it is verified by the loss of sensation to alcohol swab before target controlled infusion of propofol.It is the number of block segments.The block level varies from 0 to 10(0, no block level; 1 to 5, narrow block level;6 to 10, wide block level).

Trial Locations

Locations (1)

Jun Wang; 🇨🇳 Shenyang, Liaoning, China