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

Gastrointestinal Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02135016
• Other study ID #: 20140415
• Status: Completed
• Phase: Phase 4
• First received: April 30, 2014
• Last updated: August 28, 2014
• Start date: April 2014
• Est. completion date: July 2014

Study information

• Verified date: August 2014
• Source: First Hospital of China Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 60 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Block Level
• Gastrointestinal Surgery
• Target Controlled Infusion (TCI)
• Thoracic Epidural Anesthesia

Intervention

Drug:
• 1% lidocaine
epidural anesthesia with 1% lidocaine 10ml before propofol TCI
• 2% lidocaine
epidural anesthesia with 2% lidocaine 5ml before propofol TCI
• 0.9% normal saline
epidural anesthesia with 0.9% normal saline 5ml before propofol TCI

Locations

Country	Name	City	State
China	Jun Wang	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
First Hospital of China Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	The Bispectral Index	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 participants will be followed for the duration of anesthesia induction, an expected average of half an hour	Yes
Secondary	The Mean Blood Pressure	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 participants will be followed for the duration of anesthesia induction, an expected average of half an hour	Yes
Secondary	The Heart Rate	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 participants will be followed for the duration of anesthesia induction, an expected average of half an hour	Yes
Secondary	The Block Level of 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).	20 mins after epidural anesthesia	Yes