Total Intravenous Anesthesia and Recurrence Free Survival

  • STATUS
    Recruiting
  • End date
    Dec 9, 2024
  • participants needed
    950
  • sponsor
    The Cleveland Clinic
Updated on 9 September 2021
opioid
cancer
esophageal cancer
esophagus cancer
surgery for esophageal cancer

Summary

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.

Details
Condition cancer of the esophagus, Esophageal Carcinoma, esophagus cancer, Head and Neck Cancer, oesophageal cancer, oesophageal carcinoma, Esophageal Disorders, Esophageal Diseases, head and neck cancer, Esophageal Cancer
Treatment Propofol-based total intravenous anesthesia, Sevoflurane intravenous anesthesia
Clinical Study IdentifierNCT04513808
SponsorThe Cleveland Clinic
Last Modified on9 September 2021

Eligibility

Yes No Not Sure

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
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