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Total Intravenous Anesthesia and Recurrence Free Survival

Recruiting
18 - 90 years of age
Both
Phase 3

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Overview

The investigators propose to compare recurrence-free survival in patients having potentially curative (Stages 1-3) surgery for esophageal cancer who will be randomly assigned to propofol-based total intravenous anesthesia or sevoflurane-based balanced general anesthesia.

Description

The investigators will test the primary hypothesis that recurrence-free survival after esophageal cancer surgery is longer in patients randomized to propofol-based total intravenous anesthesia than to volatile sevoflurane anesthesia.

The investigators will test the secondary hypotheses that propofol-based total intravenous anesthesia: 1) speeds discharge from the ICU; 2) speeds discharge from the hospital; and, 3) improves the quality of recovery, as assessed by QoR-15 on postoperative day 2.

Eligibility

Inclusion Criteria:

  • Primary esophageal cancer without known extension beyond the esophagus. (i.e. believed to be Tumor Stage 1-3).
  • Scheduled for potentially curative esophageal cancer surgery.
  • Written informed consent, including willingness to be randomized to intravenous versus volatile anesthesia.

Exclusion Criteria:

  • Previous surgery for esophageal cancer (except diagnostic biopsies) Age <18 or >85 years old.
  • ASA Physical Status ≥4.
  • Any contraindication to propofol or sevoflurane.
  • Other cancer not believed by the attending surgeon to be in long-term remission.
  • Systemic disease believed by the attending surgeon to present ≥25% two- year mortality.

Study details

Esophageal Cancer

NCT04513808

The Cleveland Clinic

25 January 2024

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