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Xenon vs Desflurane in Colorectal Surgery

NCT01696630Phase 2

Key facts

Status: Completed
Start: Oct 2012
Primary completion: Jul 2014
Countries: 1
Sponsor: Centre Léon Bérard
Modality: Small Molecules

Drugs: xenon
Conditions: colorectal cancer (CRC)

Overview

Phase 2, randomised, single-blind trial of xenon in colorectal cancer (CRC) (2 arms), sponsored by Centre Léon Bérard. Primary endpoint: Variation of intraoperative Mean Arterial Pressure. Started Oct 2012; status: completed.

Design

2 arms

Study design: RandomizedSingle-blind

Xenon
Xenon 60% + Thoracic Epidural Analgesia
Desflurane
Desflurane 6.5% + Thoracic Epidural Analgesia

Who it enrols

Patients with ASA score I or II scheduled for oncologic colorectal surgery requiring thoracic epidural analgesia. Excludes patients with unstable angina, recent MI, uncontrolled hypertension, severe cardiac insufficiency, severe COPD, or history of malignant hyperthermia.

Endpoints

Primary

Variation of intraoperative Mean Arterial Pressureintraoperative

Secondary

Measure of hemodynamic parameters (Systolic Ejection Volume, Heart rate, DeltaPP)intraoperative
Delay from the surgery to the discharge datedischarge
Delay between the end of surgery and Post Anesthesia Care Unit's exitpost-operative
Total dose requirement of Vasopressive and hypotensive agentsintraoperative
Volume of each product infusedintraoperative
Total dose of morphineintraoperative
Quality of awaking5 minutes after eyes opening
Delay to oral feeding recoverypost-operative

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