Xenon-anesthesia on Patients Undergoing Major Liver-resection

NCT03504033 | Withdrawn Phase 4

• 1 other identifier: 15-163
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Liver Function After Partial Liver Resection

Keywords

Xenon; Liver resection; post-operative liver failure; anesthetics, inhalation; Desflurane; Randomized controlled trail; RCT

Outcome Measures

Primary Outcomes (1)

• Time-course of postoperative liver injury and function

  The primary study outcome is the difference in postoperative liver injury and function between the two study arms, measured by the perioperative time-course of the liver transaminase alanine-aminotransferase (ALAT) preoperative and on postoperative days (POD) 1-3, 5 and 7.

  Within the first 7 postoperative days

Secondary Outcomes (37)

• Intra- and postoperative blood loss

  Surgery and ICU stay (maximum POD 7)

• Quantity of intra- and postoperative infusions

  Surgery and ICU stay (maximum POD 7)

• Quantity of intra- and postoperative blood products

  Surgery and ICU stay (maximum POD 7)

• Quantity of intra- and postoperative coagulation products

  Surgery and ICU stay (maximum POD 7)

• Necessity and duration of surgical pringle maneuver

  Surgery

Study Arms (2)

Xenon

EXPERIMENTAL

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.

Drug: Xenon

Desflurane

ACTIVE COMPARATOR

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.

Drug: Desflurane

Interventions

Xenon DRUG

inhalation to maintain anesthesia

Also known as: LenoXe

Xenon

Desflurane DRUG

inhalation to maintain anesthesia

Also known as: Suprane

Desflurane

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• RWTH Aachen University: lead

Study Sites (1)

University Hospital RWTH Aachen University, Department of Anesthesiology

Aachen, 52074, Germany

Location

MeSH Terms

Conditions

Respiratory Aspiration

Interventions

Xenon; Desflurane

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Noble Gases; Elements; Inorganic Chemicals; Gases; Ethyl Ethers; Ethers; Organic Chemicals; Methyl Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Study Officials

• Ana Kowark, MD

  RWTH Aachen University Hospital

  PRINCIPAL INVESTIGATOR

• Mark Coburn, MD, PhD

  RWTH Aachen University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: March 14, 2018
• First Posted: April 20, 2018
• Study Start: April 11, 2018
• Primary Completion: September 27, 2019
• Study Completion: September 27, 2019
• Last Updated: October 29, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)