Effect of Thoracic Epidural Analgesia on Intravenous Closed-Loop Anesthesia

NCT00627081 | Completed Phase 4

• 1 other identifier: 2007/11
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

General Anesthesia

Outcome Measures

Primary Outcomes (1)

• amount of remifentanil delivered by the closed-loop system

  end of anesthesia

Secondary Outcomes (1)

• amount of propofol delivered by the closed-loop system

  end of anesthesia

Study Arms (2)

1

PLACEBO COMPARATOR

general anesthesia and thoracic epidural administration of saline

Drug: remifentanil

2

ACTIVE COMPARATOR

general anesthesia and thoracic epidural administration of chirocaine

Drug: remifentanil

Interventions

remifentanil DRUG

dosage

Also known as: Remifentanil: Ultiva

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients undergoing a thoracotomy under general anesthesia and epidural anesthesia

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hopital Foch: lead

Study Sites (1)

Hôpital Foch

Suresnes, 92150, France

Location

Related Publications (1)

• Liu N, Chazot T, Genty A, Landais A, Restoux A, McGee K, Laloe PA, Trillat B, Barvais L, Fischler M. Titration of propofol for anesthetic induction and maintenance guided by the bispectral index: closed-loop versus manual control: a prospective, randomized, multicenter study. Anesthesiology. 2006 Apr;104(4):686-95. doi: 10.1097/00000542-200604000-00012.

  PMID: 16571963 BACKGROUND

MeSH Terms

Interventions

Remifentanil

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Marc Fischler, MD

  Hopital Foch, 92150 Suresnes, France

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2008
• First Posted: February 29, 2008
• Study Start: February 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: January 1, 2011
• Last Updated: September 23, 2016

Record last verified: 2016-09

Locations

FR (1)