NCT00937807

Brief Summary

The purpose of this study is to compare the hemodynamics effects of two usual hypnotic agents (LENOXe ™ (xenon 100 % v/v) and sevoflurane) during a general anesthesia for carotid endarterectomy in elderly patients. The hypothesis is that the use of the LENOXe ™ (xenon 100 % v/v) allows to obtain per-operating hemodynamic stability non inferior than with sevoflurane.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2009

Shorter than P25 for phase_4

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

July 1, 2009

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

July 9, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 13, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

September 11, 2025

Status Verified

September 1, 2025

Enrollment Period

7 months

First QC Date

July 9, 2009

Last Update Submit

September 10, 2025

Conditions

Hemodynamic Stability

Keywords

hemodynamic stabilityxenoncarotid surgerygeneral anesthesia

Outcome Measures

Primary Outcomes (1)

  • Standard deviation of the values of systolic blood pressure (SBP)collected per-operatively every minutes(BIOPAC ® MP150) Values of SBP over or under thresholds during and out of the clamping period, if so vasopressive/ hypotensive treatment used

    Pre-op, every min from 1-90 min during maintenance phase

Secondary Outcomes (1)

  • cardiovascular, general, hepatic and renal tolerance to xenon. Quality and time of awakening, recovery index (IR);Post-op pain (EVA)and consumption of analgesic; Inflammatory Syndrome (cytokine profile); Subjective comfort of the patient

    During the whole anesthetic procedure and the postoperating time until 24 hours after discharge from the recovery room / intensive care unit and return to the ward

Study Arms (2)

sévoflurane

ACTIVE COMPARATOR

hypnotic use in standard general anesthesia

Drug: sévoflurane

LENOXe™ (xénon 100 % v/v)

EXPERIMENTAL

Safety of use in terms of hemodynamic stability to the LENOXe™ (xénon 100 % v/v) within the framework of the carotid surgery on the old person

Drug: xenon

Interventions

xenonDRUG

Inhalational gas; dose allowed: 60 % Xenon; the duration of the treatment will be defined through anesthesia-time for a carotid surgery

LENOXe™ (xénon 100 % v/v)
sévofluraneDRUG

Inhalation gas; dose allowed: 1,4 %; the duration of the treatment will be defined through anesthesia-time for a carotid surgery

sévoflurane

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients \> 55 years, status ASA II
  • Carotid endarterectomy elected surgery
  • Signed informed consent

You may not qualify if:

  • Related to the patients:
  • Histories of hypersensibility in both products used in the study
  • uncontrolled arterial High Blood Pressure in the preoperative anaesthesia screening
  • Severe cardiac failure (FEVG \< 30 %)
  • Major lung or airways disease and\\or required per-operating FiO2\> 35 %
  • Elevated intracranial pressure
  • Pregnancy, breast feeding
  • Major protected, under supervision, under guardianship
  • Every patient entering within the framework of the contraindications indicated to §4.3 of the summary of the characteristics of tested products (LENOXe ™ (xenon 100 % v/v), sevoflurane)
  • Related to the surgery:
  • Controlateral carotid stenosis superior to 70 % and\\or preoperative indication in the implementation per-operating of a carotid shunt
  • Surgery realized within the framework of an emergency
  • Combined Surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Pitié-Salpêtrière

Paris, 75013, France

Location

Related Publications (1)

  • Hemodynamic stability of xenon during general anaesthesia for carotid endariectomia in old patientsJune 2011European Journal of Anaesthesiology 28:45DOI:10.1097/00003643-201106001-00138 Yannick Le Manach, G. DouffléJ. P. Goarin, Irene Santos Cristina

    BACKGROUND

MeSH Terms

Interventions

Xenon

Intervention Hierarchy (Ancestors)

Noble GasesElementsInorganic ChemicalsGases

Study Officials

  • Pierre CORIAT, Pr

    Groupe Hospitalier Pitié-Salpêtrière

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2009

First Posted

July 13, 2009

Study Start

July 1, 2009

Primary Completion

February 1, 2010

Study Completion

April 1, 2010

Last Updated

September 11, 2025

Record last verified: 2025-09

Locations

FR(1)