The Impact of Anesthesia on High- Grade Glioma Patients

Anesthesia, Outcome, High-grade Glioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02756312
• Other study ID #: ChiECRCT-20200049
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: September 2020
• Source: Beijing Tiantan Hospital
• Contact: Yuming Peng, M.D., Ph.D.
• Phone: 8610-59976656
• Email: florapym766[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 196
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia, Outcome, High-grade Glioma
• Glioma

Intervention

Other:
• IV Anesthesia
The patients will receive intravenous anesthesia
• IH anesthesia
The patients will receive inhalation anesthesia

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival in18 months	overall survival in18 months	Postoperative 18 months