Cardioprotection by Sevoflurane Preconditioning in Noncardiac Thoracic Surgery

NCT ID: NCT02217319

Last Updated: 2016-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-09-30

Brief Summary

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It has been shown that the use of volatile anaesthetics, that are usually used to perform a general anesthesia, have cardioprotective properties. This has been shown in animal studies and in patients that underwent cardiac surgery. The aim of our study is to examine if Sevoflurane, a volatile anaesthetic, has this properties in patients undergoing lung surgery.

Detailed Description

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Conditions

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High Sensitive Troponin T Release

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Sevoflurane

Patients receive Sevoflurane 1 MAC (minimal alveolar concentration) after induction of anesthesia with propofol, remifentanil and atracurium for 30 minutes as preconditioning.

Group Type ACTIVE_COMPARATOR

Sevoflurane

Intervention Type DRUG

Anaesthesia is induced (1-2 mg/kg) and maintained (5-7 mg/kg/h) with propofol and remifentanil (1 µg/kg and 0,2-0,4 µg/kg/min). After induction of anesthesia the propofol infusion is stopped and patients receive 1 MAC Sevoflurane over 30 min. Then the propofol infusion is restarted and Sevoflurane is washed out.

TIVA

Patients received the standard total intravenous anesthesia (TIVA) with propofol, remifentanil and atracurium.

Group Type PLACEBO_COMPARATOR

TIVA

Intervention Type DRUG

Anaesthesia is induced (1-2 mg/kg) and maintained (5-7 mg/kg/h) with propofol and remifentanil (1 µg/kg and 0,2-0,4 µg/kg/min).

Interventions

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Sevoflurane

Anaesthesia is induced (1-2 mg/kg) and maintained (5-7 mg/kg/h) with propofol and remifentanil (1 µg/kg and 0,2-0,4 µg/kg/min). After induction of anesthesia the propofol infusion is stopped and patients receive 1 MAC Sevoflurane over 30 min. Then the propofol infusion is restarted and Sevoflurane is washed out.

Intervention Type DRUG

TIVA

Anaesthesia is induced (1-2 mg/kg) and maintained (5-7 mg/kg/h) with propofol and remifentanil (1 µg/kg and 0,2-0,4 µg/kg/min).

Intervention Type DRUG

Other Intervention Names

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Placebo Controll

Eligibility Criteria

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Inclusion Criteria

* Lung surgery
* ASA (American Society of Anesthesiologists) physical status 1-3

Exclusion Criteria

* Disposition for malignant hyperthermia
* Medication with ß-blocking drugs
* Use of clonidin
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr. Horst Schmidt Klinik GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Dr Horst Schmidt Klinik

Wiesbaden, , Germany

Site Status

Countries

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Germany

Other Identifiers

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HSK005

Identifier Type: -

Identifier Source: org_study_id

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