Influence of Anesthesia Methods on CTCs in TURBT Patients

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

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-15

Study Completion Date

2024-06-30

Brief Summary

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Multiple lines of evidence have shown that anesthesia method is associated with long-term outcomes in patients undergoing surgery due to cancers, including lung, breast, prostate, and bladder cancer, etc. Circulating tumor cells (CTCs) have been validated as prognostic biomarkers of a number of cancers. The aim of this study is to investigate the effects of anesthesia methods on the number of CTCs in patients receiving transurethral resection of bladder tumor (TURBT). The difference of anesthesia method is achieved by using general anesthesia in one group and spinal anesthesia in the other group.

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Detailed Description

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Conditions

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Bladder Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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General Anesthesia

Patients in this group will receive general anesthesia during TURBT.

Group Type ACTIVE_COMPARATOR

General Anesthesia

Intervention Type PROCEDURE

Patients will have TURBT under general anesthesia, which is induced with midazolam, propofol, sufentanil and rocuronium. The patients will be mechanically ventilated with laryngeal mask airway (LMA). Anesthesia will be maintained with sevoflurane/desflurane, propofol and remifentanil.

Spinal Anesthesia

Patients in this group will receive spinal anesthesia during TURBT.

Group Type EXPERIMENTAL

Spinal Anesthesia

Intervention Type PROCEDURE

Patients will have TURBT under spinal anesthesia. 10\~15mg of 0.5% ropivacaine will be injected in the subarachnoid cerebrospinal fluid at the levels of L2-L3 or L3-L4 in lumbar space. It will numb the nerve supply of the belly, hips, bottom as well as legs. The patient stays awake and won't feel any pain due to operation.

Interventions

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General Anesthesia

Patients will have TURBT under general anesthesia, which is induced with midazolam, propofol, sufentanil and rocuronium. The patients will be mechanically ventilated with laryngeal mask airway (LMA). Anesthesia will be maintained with sevoflurane/desflurane, propofol and remifentanil.

Intervention Type PROCEDURE

Spinal Anesthesia

Patients will have TURBT under spinal anesthesia. 10\~15mg of 0.5% ropivacaine will be injected in the subarachnoid cerebrospinal fluid at the levels of L2-L3 or L3-L4 in lumbar space. It will numb the nerve supply of the belly, hips, bottom as well as legs. The patient stays awake and won't feel any pain due to operation.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. .≤18 Age ≤85，ASAI-III.
2. .Patients with primary bladder cancer of Stage T1 to T4, who are scheduled for transurethral resection of bladder tumor.
3. .Written informed consent.

Exclusion Criteria

1. History of surgery within 6 months.
2. Contraindications for spinal anesthesia.
3. With a history of any other malignancy.
4. Having received preoperative neoadjuvant therapy.
5. History of long-term opioid use.
6. Combined with autoimmune diseases or having a history of prolonged hormone use or immunosuppressant use within 1 year.
7. Combined with impaired liver function (Child - Pugh C) or renal insufficiency (serum creatinine level over 442μmol•L-1).
8. Known hypersensitivity or suspected allergy to intervention drugs.
9. Proposed postoperative admission to ICU.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No