NCT01757106

Brief Summary

Purpose of this study is to test whether xenon application during off-pump-coronary artery bypass (OPCAB)-surgery is safe and feasible.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at below P25 for phase_2 coronary-artery-disease

Timeline
Completed

Started Dec 2012

Shorter than P25 for phase_2 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

December 3, 2012

Completed
25 days until next milestone

First Posted

Study publicly available on registry

December 28, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

March 26, 2014

Status Verified

March 1, 2014

Enrollment Period

7 months

First QC Date

December 3, 2012

Last Update Submit

March 24, 2014

Conditions

Coronary Artery DiseaseAnesthesia

Keywords

xenon anesthesiasevoflurane anesthesiaoff-pump coronary artery bypass graft surgery

Outcome Measures

Primary Outcomes (1)

  • Feasibility/Safety of xenon anesthesia

    assessed by: depth of anesthesia, perioperative hemodynamic profile, peripheral and arterial oxygen saturation

    Intraoperatively

Secondary Outcomes (2)

  • Major adverse cardiac and cerebral events (MACCE)

    up to six months after surgery

  • Incidence and duration of postoperative delirium

    up to five days after surgery

Other Outcomes (6)

  • Other secondary efficacy/safety measures

    up to five days after surgery

  • Other secondary efficacy/safety measures

    up to five days after surgery

  • Other secondary efficacy/safety measures

    until discharge from the hospital

  • +3 more other outcomes

Study Arms (2)

Drug: Xenon

EXPERIMENTAL

gaseous anesthetic, dosage: 50-60% (v/v) in oxygen, continuous application during surgery

Drug: Xenon

Drug: Sevoflurane

ACTIVE COMPARATOR

inhalative anesthetic, dosage: 1.4% (v/v) in 50% oxygen/medical air , continuous application during surgery

Drug: sevoflurane

Interventions

XenonDRUG

general anaesthesia with xenon 50-60% in oxygen (FiO2=0.4-0.5)

Drug: Xenon
sevofluraneDRUG

general anesthesia with sevoflurane 1.4% in 50% oxygen/medical air

Drug: Sevoflurane

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with coronary artery disease scheduled for elective OPCAB- surgery
  • Patients willing and able to complete the requirements of this study
  • Ejection Fraction \> 30%

You may not qualify if:

  • Lack of informed consent
  • Age \< 18 years
  • Pregnancy
  • chronic obstructive pulmonary disease (COPD) GOLD \> II
  • Renal dysfunction defined as serum-creatinine \> 1.5 mg/dl
  • Acute coronary syndrome during the last 24 hours; haemodynamic instability, requirement of inotropic support
  • Single vessel grafting
  • Disabling neuropsychiatric disorders (severe dementia, Alzheimer's disease, schizophrenia, depression), history of stroke with residuals, significant stenosis of carotid arteries, increased intracranial pressure
  • Hypersensitivity to the study medication
  • Presumed uncooperativeness or legal incapacity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Leuven

Leuven, 3000, Belgium

Location

Related Publications (1)

  • Al Tmimi L, Van Hemelrijck J, Van de Velde M, Sergeant P, Meyns B, Missant C, Jochmans I, Poesen K, Coburn M, Rex S. Xenon anaesthesia for patients undergoing off-pump coronary artery bypass graft surgery: a prospective randomized controlled pilot trial. Br J Anaesth. 2015 Oct;115(4):550-9. doi: 10.1093/bja/aev303.

    PMID: 26385664DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

XenonSevoflurane

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Noble GasesElementsInorganic ChemicalsGasesMethyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbons

Study Officials

  • Steffen Rex, PhD

    UZ Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

December 3, 2012

First Posted

December 28, 2012

Study Start

December 1, 2012

Primary Completion

July 1, 2013

Study Completion

January 1, 2014

Last Updated

March 26, 2014

Record last verified: 2014-03

Locations

BE(1)