The Impact of Anesthesia on High- Grade Glioma Patients

NCT ID: NCT02756312

Last Updated: 2020-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

196 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2022-12-31

Brief Summary

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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

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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.

Conditions

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Anesthesia, Outcome, High-grade Glioma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

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

Study Groups

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Intravenous anesthesia

Patients will receive total intravenous anesthesia undergoing brain tumor resection.

Group Type OTHER

IV Anesthesia

Intervention Type OTHER

The patients will receive intravenous anesthesia

Inhalation anesthesia

Patients will receive volatile inhalational anesthesia undergoing brain tumor resection.

Group Type OTHER

IH anesthesia

Intervention Type OTHER

The patients will receive inhalation anesthesia

Interventions

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IV Anesthesia

The patients will receive intravenous anesthesia

Intervention Type OTHER

IH anesthesia

The patients will receive inhalation anesthesia

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Tiantan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yuming Peng

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Central Contacts

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

Role: CONTACT

8610-59976656

Facility Contacts

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Yuming Peng

Role: primary

Jia Dong

Role: backup

References

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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.

Reference Type DERIVED
PMID: 36167574 (View on PubMed)

Other Identifiers

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ChiECRCT-20200049

Identifier Type: -

Identifier Source: org_study_id

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