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Total Intravenous Anesthesia and Recurrence Free Survival

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ClinicalTrials.gov Identifier: NCT04513808
Recruitment Status : Recruiting
First Posted : August 14, 2020
Last Update Posted : August 30, 2021
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Drug: Propofol-based total intravenous anesthesia Drug: Sevoflurane intravenous anesthesia Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 950 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Total IntraVenous AnesthesIa and ReCurrence-free Survival AfTer EsOphageal CanceR SurgerY
Actual Study Start Date : August 15, 2020
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Propofol-based total intravenous anesthesia
Propofol-based total intravenous anesthesia. A target-controlled infusion will be set to 2-4 µg/ml plasma concentrations, and varied as clinical necessary.
 Drug: Propofol-based total intravenous anesthesia
Patients will normally be given dexamethasone 10 mg and ramosetron 0.3-0.6 mg prophylaxis for postoperative nausea and vomiting. Rescue treatment will be provided per clinical routine. Post-operative analgesia will be opioid-based, typically sufentanil and dezocine via patient-controlled pump. Analgesic adjuvants will be used per clinician preference.
Active Comparator: Sevoflurane intravenous anesthesia
Anesthesia will be maintained with sevoflurane, typically at an end-tidal concentration of 0.6-1.0 MAC, but adjusted as clinically necessary
 Drug: Sevoflurane intravenous anesthesia
Patients will normally be given dexamethasone 10 mg and ramosetron 0.3-0.6 mg prophylaxis for postoperative nausea and vomiting. Rescue treatment will be provided per clinical routine. Post-operative analgesia will be opioid-based, typically sufentanil and dezocine via patient-controlled pump. Analgesic adjuvants will be used per clinician preference.


Outcome Measures
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Primary Outcome Measures :
  1. Recurrence-free survival [ Time Frame: 4 years ]
    The investigators will use the randomized groups to descriptively compared on all baseline variables using summary statistics such as mean and standard deviation, median and quartiles or frequency and percent, as appropriate.


Secondary Outcome Measures :
  1. The treatment effect of propofol-based anesthesia versus volatile anesthesia. [ Time Frame: up to 2 day ]
    The investigators will use a Cox proportional hazards time to event model to assess the treatment effect.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04513808


Contacts
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Contact: Daniel Sessler, MD 216-444-4900 ds@or.org
Contact: Roberta Johnson 216-444-9950 johnsor13@ccf.org

Locations
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China
Shanhai Chest Hospital Recruiting
Shanghai, China
Contact: Roberta Johnson    216-444-9950    johnsor13@ccf.org   
Contact: Yuwei Qui, MD       qqiuyuweixk@163.com   
Sponsors and Collaborators
The Cleveland Clinic
Investigators
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Principal Investigator: Yuwei Oui, MD Shahai Hospital
More Information
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Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT04513808    
Other Study ID Numbers: VICTORY
First Posted: August 14, 2020    Key Record Dates
Last Update Posted: August 30, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Esophageal Neoplasms
Recurrence
Disease Attributes
Pathologic Processes
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
 Gastrointestinal Diseases
Anesthetics
Propofol
Sevoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Platelet Aggregation Inhibitors
Anesthetics, Inhalation