Xenon-anesthesia on Patients Undergoing Major Liver-resection

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

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-11

Study Completion Date

2019-09-27

Brief Summary

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The aim of this study is to compare the postoperative outcome of patients undergoing major liver resection under xenon- compared to desflurane-anesthesia.

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Detailed Description

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The aim of this study is to compare the postoperative liver function and additional outcome parameters of patients undergoing major liver resection under xenon- compared to desflurane-anesthesia. Xenon is known to maintain hemodynamic stability and consecutive tissue perfusion. Together with its potential for ischemic pre-conditioning, we hypothesize a protective effect of xenon on post-operative liver failure and ischemia/reperfusion injury.

Conditions

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Liver Function After Partial Liver Resection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Single-center, controlled, double-blinded, randomized, two-arm parallel, interventional clinical trial

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

This trial will be performed double-blinded. After randomization neither the patients nor the investigator of the baseline assessment and the postoperative assessment will be aware of the treatment allocation. The intraoperative anesthesiologist will not be blinded, due to feasibility and safety reasons.

Study Groups

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Xenon

Xenon concentration of 50-60 % will be used for maintenance of general anesthesia and will be adjusted to maintain Bispectral index (BIS) value between 40 and 60.

Group Type EXPERIMENTAL

Xenon

Intervention Type DRUG

inhalation to maintain anesthesia

Desflurane

Desflurane concentrations of 4-5%/0.8 minimum alveolar concentration (MAC) respectively will be used for maintenance of general anesthesia and will be adjusted to maintain BIS index value between 40 and 60.

Group Type ACTIVE_COMPARATOR

Desflurane

Intervention Type DRUG

inhalation to maintain anesthesia

Interventions

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Xenon

inhalation to maintain anesthesia

Intervention Type DRUG

Desflurane

inhalation to maintain anesthesia

Intervention Type DRUG

Other Intervention Names

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LenoXe Suprane

Eligibility Criteria

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Inclusion Criteria

* ≥ 3 segments liver resection
* ≥ 18 years
* Both gender
* American Society of Anesthesiologists (ASA) classification I-III
* Written informed consent prior to study participation

Exclusion Criteria

* Severe pulmonary or airway disease
* Severe liver disease, accompanied by a Child-Pugh class \>A
* Allergy/hypersensitivity to study medications
* ASA ≥ IV
* Patients susceptible to malignant hyperthermia
* Women who are pregnant, breast-feeding or women of childbearing potential not using adequate contraceptive methods
* Patients with preeclampsia or eclampsia
* Patients legally unable to give written informed consent.
* Patients with risk of high oxygen demand
* Patient with seriously impaired cardiac function
* All contraindications for xenon anesthesia according to the summary of product characteristics LENOXe
* Patient participates in a parallel interventional clinical trial during this study or receives an investigational drug within 30 days prior to inclusion into this study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No