Phase 4 N=45 Randomized Double-blind Treatment

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

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

Bottom Line

View on ClinicalTrials.gov: NCT02135016 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2014

Primary outcome: Primary: The Effect-site Concentration of Propofol — 1.51; 1.99; 2.68 µg/ml

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: 1% lidocaine (Drug); 2% lidocaine (Drug); 0.9% normal saline (Drug)
Age: Adult · 40+ yrs
Sex: All
Sponsor: First Hospital of China Medical University
Primary completion: Jul 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY The Effect-site Concentration of Propofol	1.51; 1.99; 2.68	—
SECONDARY The Bispectral Index	95.4; 95.4; 95.7; 85.3; 85.1; 94.5	—
SECONDARY The Mean Blood Pressure	95.4; 95.1; 95.9; 85.9; 83.7; 95.5	—
SECONDARY The Heart Rate	71.4; 72.8; 71.3; 69.8; 69.2; 71.3	—
SECONDARY The Block Level of Epidural Anesthesia	6.5; 4.2; 0	—

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02135016). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.