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Clinical Trials/NCT02756312
NCT02756312
Unknown
Not Applicable

The Impact of Anesthesia on the Outcome of Supratentorial High- Grade Glioma Patients After Craniotomy

Beijing Tiantan Hospital1 site in 1 country196 target enrollmentOctober 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anesthesia, Outcome, High-grade Glioma
Sponsor
Beijing Tiantan Hospital
Enrollment
196
Locations
1
Primary Endpoint
overall survival in18 months
Last Updated
5 years ago

Overview

Brief Summary

Although bench data and retrospective studies have provided a promising picture of the possible influence of anesthetic technique on the risk of tumor progression and patients mortality, current evidence from RCTs is inadequate to show whether the type of anesthetics might influence tumor progression and patient survival.There are many thousands of patients with a cancer diagnosis undergoing surgery every year, and in the context of biological plausibility, it should lead to the urgent undertaking of RCTs to further evaluate the association between the anesthetic management and patient outcome.

Detailed Description

Although bench data and retrospective studies have provided a promising picture of the possible influence of anesthetic technique on the risk of tumor progression and patient mortality, current evidence from RCTs is inadequate to show whether the type of anesthetics might influence the outcome of the patients.There are many thousands of patients with a cancer diagnosis undergoing surgery every year, and in the context of biological plausibility, it should lead to the urgent undertaking of RCTs to further evaluate the association between the anesthetic management and patient outcome.

Registry
clinicaltrials.gov
Start Date
October 1, 2020
End Date
December 31, 2022
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Beijing Tiantan Hospital
Responsible Party
Principal Investigator
Principal Investigator

Yuming Peng

Professor

Beijing Tiantan Hospital

Eligibility Criteria

Inclusion Criteria

  • Magnetic radiology imaging diagnosis of supratentorial high-grade glioma; 2) Patients undergoing tumor resection under selective general anesthesia; 3) Age 18-80 years old; 4) Preoperative KPS \< 80; 5) With written informed consent by patients or their relatives.

Exclusion Criteria

  • History of other operations before; 2) Patients with recurrence and metastasis of gliomas or with malignant tumors of other organs; 3) Emergency operation; 4) Critical condition (ASA grade ≥ V before operation, Appendix 1, Severe liver and kidney dysfunction; 5) Patients with mental illness, severe dementia, language disorder, coma, and end-stage disease, etc.; 6) Pregnant or breastfeeding women; 7) Allergic to study drugs;8) Patients who need electrophysiological monitoring during operation. 9) Patients receiving reoperation with different anesthesia methods will be removed and the patients with the same anesthesia method will be continued to observe; 10) Postoperative pathological result is not high-grade glioma.

Outcomes

Primary Outcomes

overall survival in18 months

Time Frame: Postoperative 18 months

overall survival in18 months

Study Sites (1)

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