Total Intravenous Anesthesia and Recurrence Free Survival

NeuroTherapia, Inc.

Status and phase: Enrolling; Phase 3

Conditions: Esophageal Cancer

Treatments: Drug: Propofol-based total intravenous anesthesia; Drug: Sevoflurane intravenous anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT04513808

VICTORY

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,614 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,614 participants in 2 patient groups

Propofol-based total intravenous anesthesia

Active Comparator group

Description:

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

Treatment:

Drug: Propofol-based total intravenous anesthesia

Sevoflurane intravenous anesthesia

Active Comparator group

Description:

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

Treatment:

Drug: Sevoflurane intravenous anesthesia