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Effect of Thoracic Epidural Analgesia on Intravenous Closed-Loop Anesthesia

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00627081
Acronym
Drone-APDT
Enrollment
40
Registered
2008-02-29
Start date
2008-02-29
Completion date
2011-01-31
Last updated
2016-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

General Anesthesia

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.

Interventions

DRUGremifentanil

dosage

Sponsors

Hopital Foch
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
amount of remifentanil delivered by the closed-loop systemend of anesthesia

Secondary

MeasureTime frame
amount of propofol delivered by the closed-loop systemend of anesthesia

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026