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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00627081
Other study ID # 2007/11
Secondary ID
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


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
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