The Impact of Anesthesia on High- Grade Glioma Patients

Not Applicable

• Conditions: Anesthesia, Outcome, High-grade Glioma
• Interventions: Other: IH anesthesia; Other: IV Anesthesia

• Registration Number: NCT02756312
• Lead Sponsor: Beijing Tiantan Hospital

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.

Study Timeline

• Study First Submitted: 2016-04-27
• Study First Submitted QC: 2016-04-27
• Study First Posted: 2016-04-29
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-06
• Last Update Posted: 2020-09-09
• Study Start: 2020-10-01
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 196

Inclusion Criteria

1)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

1. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inhalation anesthesia	IH anesthesia	Patients will receive volatile inhalational anesthesia undergoing brain tumor resection.
Intravenous anesthesia	IV Anesthesia	Patients will receive total intravenous anesthesia undergoing brain tumor resection.

Primary Outcome Measures

Name	Time	Method
overall survival in18 months	Postoperative 18 months	overall survival in18 months

Trial Locations

Locations (1)

Beijing Tiantan Hospital; 🇨🇳 Beijing, Beijing, China