Total Intravenous Anesthesia and Recurrence Free Survival

Phase 3

Recruiting

• Conditions: Esophageal Cancer
• Interventions: Drug: Sevoflurane intravenous anesthesia; Drug: Propofol-based total intravenous anesthesia

• Registration Number: NCT04513808
• Lead Sponsor: The Cleveland Clinic

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.

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 Timeline

• Study First Submitted: 2020-05-12
• Study First Submitted QC: 2020-08-12
• Study First Posted: 2020-08-14
• Study Start: 2020-08-15
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-04
• Primary Completion: 2025-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1614

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sevoflurane intravenous anesthesia	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
Propofol-based total intravenous anesthesia	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.

Primary Outcome Measures

Name	Time	Method
Recurrence-free survival	4 years	Patients who did not experience cancer recurrence and/or death.

Secondary Outcome Measures

Name	Time	Method
QoR-15	2 days	Quality of Recovery 15 score on postoperative day 2.
Hospital duration	Up to 100 months	Postoperative time spent in hospital during initial admission.
ICU duration	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.

Trial Locations

Locations (1)

Shanhai Chest Hospital; 🇨🇳 Shanghai, China