Effect of Thoracic Epidural Analgesia on Intravenous Closed-Loop Anesthesia

Phase 4

Completed

• Conditions: General Anesthesia
• Interventions: Drug: remifentanil

• Registration Number: NCT00627081
• Lead Sponsor: Hopital Foch

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-02-20
• Study First Submitted QC: 2008-02-20
• Study First Posted: 2008-02-29
• Primary Completion: 2010-12
• Study Completion: 2011-01
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-22
• Last Update Posted: 2016-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• patients undergoing a thoracotomy under general anesthesia and epidural anesthesia

Exclusion Criteria

• age lower than 18 years,
• pregnant woman,
• psychotropic treatment,
• central neurological disorder or lesion cerebral,
• allergy to propofol or to a muscle relaxant,
• refusal or contra-indication of epidural anesthesia,
• severe emphysema,
• coronary disease,
• treatment with a beta-blocker or a vasoactive drug.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	remifentanil	general anesthesia and thoracic epidural administration of chirocaine
1	remifentanil	general anesthesia and thoracic epidural administration of saline

Primary Outcome Measures

Name	Time	Method
amount of remifentanil delivered by the closed-loop system	end of anesthesia

Secondary Outcome Measures

Name	Time	Method
amount of propofol delivered by the closed-loop system	end of anesthesia

Trial Locations

Locations (1)

Hôpital Foch; 🇫🇷 Suresnes, France