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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propofol-based total intravenous anesthesia | Active Comparator | Propofol-based total intravenous anesthesia. A target-controlled infusion will be set to 2-4 µg/ml plasma concentrations, and varied as clinical necessary. |
|
| Sevoflurane intravenous anesthesia | Active Comparator | Anesthesia will be maintained with sevoflurane, typically at an end-tidal concentration of 0.6-1.0 MAC, but adjusted as clinically necessary |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propofol-based total intravenous anesthesia | Drug | Propofol-based total intravenous anesthesia, titrated to clinical need. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence-free survival | Patients who did not experience cancer recurrence and/or death. | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| ICU duration | Postoperative time in ICU during initial admission. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniel I Sessler, MD | Contact | 216-870-2620 | DS@CCF.org | |
| Fabio Rodriquez Patarroyo, MD | Contact | â€(216) 444-9674‬ | Rodrigf3@ccf.org |
| Name | Affiliation | Role |
|---|---|---|
| Yuwei Oui, MD | Shahai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanhai Chest Hospital | Recruiting | Shanghai | China |
Data will be shared collaboratively with appropriate approvals and contracts.
2 years after publication of the main paper.
Contact investigators.
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| D000077149 | Sevoflurane |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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As usual with time-to-event outcomes, enrollment will be based on the number of outcome events, not the number of patients enrolled. We anticipate that about 1614 patients will be required to generate 579 recurrences and/or deaths, but this is only a rough estimate since follow-up duration is a function of when patients are enrolled, not just their number.
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|
| Sevoflurane intravenous anesthesia | Drug | Sevoflurane intravenous anesthesia, titrated to clinical need. |
|
|
Postoperative time spent in hospital during initial admission.
| Up to 100 months |
| QoR-15 | Quality of Recovery 15 score on postoperative day 2. | 2 days |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |