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Effect of Thoracic Epidural Analgesia on Intravenous Closed-Loop Anesthesia

NCT00627081 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2016-09-23

No results posted yet for this study

Summary

The association of general anesthesia and of thoracic epidural anesthesia is used in thoracic surgery with a demonstrated benefit on the risk of postoperative respiratory complications.

The objective of the study is to analyze the influence of thoracic epidural administration of chirocaine (5 mg/ml) on the administration of anesthetic agents (propofol and remifentanil), these drugs being administrated using a closed-loop system with the Bispectral Index as the controller.

Two groups of patients are compared:

* one group will receive general anesthesia and thoracic epidural administration of saline. Chirocaine will be administered before patient's awakening,
* one group will receive general anesthesia and thoracic epidural administration of chirocaine (5 mg/ml).

In both groups, the closed-loop system ensures that le depth of anesthesia is similar in both groups.

Conditions

  • General Anesthesia

Interventions

DRUG

remifentanil

dosage

Sponsors & Collaborators

  • Hopital Foch

    lead OTHER

Principal Investigators

  • Marc Fischler, MD · Hopital Foch, 92150 Suresnes, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2010-12-31
Completion
2011-01-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00627081 on ClinicalTrials.gov