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Clinical Trials/NCT05824299
NCT05824299
Not yet recruiting
Not Applicable

Influence of General Anesthesia Versus Spinal Anesthesia on Circulating Tumor Cells in Patients Undergoing Transurethral Resection of Bladder Tumor

RenJi Hospital1 site in 1 country162 target enrollmentAugust 15, 2023
ConditionsBladder Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bladder Cancer
Sponsor
RenJi Hospital
Enrollment
162
Locations
1
Primary Endpoint
the number of Circulating Tumor Cells
Status
Not yet recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 15, 2023
End Date
June 30, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jie Tian

Principal Investigator

RenJi Hospital

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

the number of Circulating Tumor Cells

Time Frame: 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 Outcomes

  • Nausea Score(at 24 hours after surgery)
  • Visual Analogue Scale(at 24 hours after surgery)
  • Surgeon Satisfaction(immediately after surgery)
  • Patient Satisfaction(within 24 hours after surgery)
  • Hospitalization Days(up to 30 days)

Study Sites (1)

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