Total Intravenous Anesthesia and Recurrence Free Survival
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Propofol-based total intravenous anesthesia, Sevoflurane intravenous anesthesia.
- Who it may be relevant to
- Registry conditions: Esophageal Cancer. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Total IntraVenous AnesthesIa and ReCurrence-free Survival AfTer EsOphageal CanceR SurgerY
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.
Detailed 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.
Interventions
- Drug Propofol-based total intravenous anesthesia
Propofol-based total intravenous anesthesia, titrated to clinical need. - Drug Sevoflurane intravenous anesthesia
Sevoflurane intravenous anesthesia, titrated to clinical need.
Primary outcome measures
- Recurrence-free survival [Time frame: 4 years]
Secondary outcome measures (3)
- ICU duration [Time frame: From ICU admission until the date of ICU discharge or date of death from any cause, whichever came first, assessed up to 100 months]
- Hospital duration [Time frame: Up to 100 months]
- QoR-15 [Time frame: 2 days]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shanhai Chest Hospital — Shanghai
Identifiers
NCT: NCT04513808 · VICTORY