Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04513808

Total Intravenous Anesthesia and Recurrence Free Survival

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Shanhai Chest Hospital

Shanghai, China

Location status: Recruiting

Location contact

Yuwei

CONTACT

Yuwei Qui, MD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Propofol-based total intravenous anesthesia

Drug

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

Other names: Propofol

Sevoflurane intravenous anesthesia

Drug

Sevoflurane intravenous anesthesia, titrated to clinical need.

Other names: Sevoflurane

Primary outcomes

  1. Recurrence-free survival

    Time frame: 4 years

    Patients who did not experience cancer recurrence and/or death.

Secondary outcomes

  1. 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

    Postoperative time in ICU during initial admission.

  2. Hospital duration

    Time frame: Up to 100 months

    Postoperative time spent in hospital during initial admission.

  3. QoR-15

    Time frame: 2 days

    Quality of Recovery 15 score on postoperative day 2.

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel I Sessler, MD

CONTACT

[email protected]

216-870-2620

Fabio Rodriquez Patarroyo, MD

CONTACT

[email protected]

‭(216) 444-9674‬

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

Total IntraVenous AnesthesIa and ReCurrence-free Survival AfTer EsOphageal CanceR SurgerY

Important dates

Study start
2020
Primary completion
2025
Study completion
2027
First posted
Aug 14, 2020
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.