Effect of Thoracic Epidural Analgesia on Intravenous Closed-Loop Anesthesia

General Anesthesia Clinical Trial

— Drone-APDT  

Official title:

Intravenous Opioid-sparing Effect of Thoracic Epidural Administration of Chirocaine (5 mg/ml) During Thoracotomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00627081
• Other study ID #: 2007/11
• Status: Completed
• Phase: Phase 4
• First received: February 20, 2008
• Last updated: September 22, 2016
• Start date: February 2008
• Est. completion date: January 2011

Study information

• Verified date: September 2016
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• General Anesthesia

Intervention

Drug:
• remifentanil
dosage

Locations

Country	Name	City	State
France	Hôpital Foch	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

References & Publications (1)

Liu N, Chazot T, Genty A, Landais A, Restoux A, McGee K, Laloë 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	amount of remifentanil delivered by the closed-loop system		end of anesthesia	No
Secondary	amount of propofol delivered by the closed-loop system		end of anesthesia	No