Trial | NCT04513808  Report issue

Title

Total Intravenous Anesthesia and Recurrence Free Survival
Total IntraVenous AnesthesIa and ReCurrence-free Survival AfTer EsOphageal CanceR SurgerY

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Recruiting

  • Study Participants

    1614
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.
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.
Study Started
Aug 15
2020
Primary Completion
Dec 31
2025
Anticipated
Study Completion
Dec 31
2027
Anticipated
Last Update
Nov 15
2023

Drug Propofol-based total intravenous anesthesia

Propofol-based total intravenous anesthesia, titrated to clinical need.

  • Other names: Propofol

Drug Sevoflurane intravenous anesthesia

Sevoflurane intravenous anesthesia, titrated to clinical need.

  • Other names: Sevoflurane

Propofol-based total intravenous anesthesia Active Comparator

Propofol-based total intravenous anesthesia. A target-controlled infusion will be set to 2-4 µg/ml plasma concentrations, and varied as clinical necessary.

Sevoflurane intravenous anesthesia Active Comparator

Anesthesia will be maintained with sevoflurane, typically at an end-tidal concentration of 0.6-1.0 MAC, but adjusted as clinically necessary

Criteria 

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.
No Results Posted