Back to results

The Impact of Anesthesia on High- Grade Glioma Patients

Primary Purpose

Anesthesia, Outcome, High-grade Glioma

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

IV Anesthesia

IH anesthesia

About this trial

This is an interventional treatment trial for Anesthesia, Outcome, High-grade Glioma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Beijing Tiantan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Intravenous anesthesia

Inhalation anesthesia

Arm Description

Patients will receive total intravenous anesthesia undergoing brain tumor resection.

Patients will receive volatile inhalational anesthesia undergoing brain tumor resection.

Outcomes

Primary Outcome Measures

overall survival in18 months

Secondary Outcome Measures

Full Information

NCT ID

NCT02756312

First Posted

April 27, 2016

Last Updated

September 6, 2020

Sponsor

Beijing Tiantan Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02756312

Brief Title

The Impact of Anesthesia on High- Grade Glioma Patients

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Unknown status

Study Start Date

October 1, 2020 (Anticipated)

Primary Completion Date

December 31, 2022 (Anticipated)

Study Completion Date

December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Beijing Tiantan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anesthesia, Outcome, High-grade Glioma

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

This is a single centre, randomized, parallel group controlled clinical trial in patients with primary HGG. All eligible patients will be 1:1 randomized to the TIVA or INHA group. The object of the trail is to evaluate the effect of propofol or sevoflurane on the prognosis of supratentorial HGG patients after craniotomy.

Masking

ParticipantInvestigatorOutcomes Assessor

Masking Description

The anesthesiologist know the grouping .The subjects and the outcome assesor trained for telephone visit were blinded to the grouping

Allocation

Randomized

Enrollment

196 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intravenous anesthesia

Arm Type

Other

Arm Description

Patients will receive total intravenous anesthesia undergoing brain tumor resection.

Arm Title

Inhalation anesthesia

Arm Type

Other

Arm Description

Patients will receive volatile inhalational anesthesia undergoing brain tumor resection.

Intervention Type

Other

Intervention Name(s)

IV Anesthesia

Intervention Description

The patients will receive intravenous anesthesia

Intervention Type

Other

Intervention Name(s)

IH anesthesia

Intervention Description

The patients will receive inhalation anesthesia

Primary Outcome Measure Information:

Title

overall survival in18 months

Description

overall survival in18 months

Time Frame

Postoperative 18 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yuming Peng, M.D., Ph.D.

Phone

8610-59976656

florapym766@163.com

Facility Information:

Facility Name

Beijing Tiantan Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100070

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yuming Peng

First Name & Middle Initial & Last Name & Degree

Jia Dong

12. IPD Sharing Statement

Citations:

PubMed Identifier

36167574

Citation

Dong J, Wang D, Sun H, Zeng M, Liu X, Yan X, Li R, Li S, Peng Y. Effect of anesthesia on the outcome of high-grade glioma patients undergoing supratentorial resection: study protocol for a pragmatic randomized controlled trial. Trials. 2022 Sep 27;23(1):816. doi: 10.1186/s13063-022-06716-9.

Results Reference

derived

Learn more about this trial

The Impact of Anesthesia on High- Grade Glioma Patients

We'll reach out to this number within 24 hrs