Influence of Anesthesia Methods on CTCs in TURBT Patients

Not Applicable

Not yet recruiting

• Conditions: Bladder Cancer
• Interventions: Procedure: General Anesthesia; Procedure: Spinal Anesthesia

• Registration Number: NCT05824299
• Lead Sponsor: RenJi Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-09
• Study First Submitted QC: 2023-04-09
• Study First Posted: 2023-04-21
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-08
• Last Update Posted: 2023-08-09
• Study Start: 2023-08-15
• Primary Completion: 2024-04-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 162

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
General Anesthesia	General Anesthesia	Patients in this group will receive general anesthesia during TURBT.
Spinal Anesthesia	Spinal Anesthesia	Patients in this group will receive spinal anesthesia during TURBT.

Primary Outcome Measures

Name	Time	Method
the number of Circulating Tumor Cells	on the Day 7~10 after surgery	The number of circulating tumor cells will be measured by collecting 5 ml of venous blood sample.

Secondary Outcome Measures

Name	Time	Method
Nausea Score	at 24 hours after surgery	Nausea score will be assessed using the Numerical Rating Scale, which ranges from 0 to 10, with a higher score indicating greater nausea ou score at 24 hours after surgery.
Visual Analogue Scale	at 24 hours after surgery	Pain intensity will be assessed using the Visual Analogue Scale, which ranges from 0 to 10, with a higher score indicating greater pain intensity at 24 hours after surgery.
Surgeon Satisfaction	immediately after surgery	The surgeon satisfaction will be measured with the Likert scale, which ranges from 0 to 50, with a higher score indicating higher satisfaction.
Patient Satisfaction	within 24 hours after surgery	The patient satisfaction will be measured with the Modified Bauer Scale, which ranges from 0 to 50, with a higher score indicating higher satisfaction.
Hospitalization Days	up to 30 days	The length of hospital stay will be recorded.

Trial Locations

Locations (1)

Renji Hospital affliated to Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China