NCT05824299

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
162

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 21, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

August 15, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

August 9, 2023

Status Verified

August 1, 2023

Enrollment Period

9 months

First QC Date

April 9, 2023

Last Update Submit

August 8, 2023

Conditions

Bladder Cancer

Keywords

Circulating Tumor CellsGeneral AnesthesiaSpinal AnesthesiaTransurethral Resection of Bladder Tumor

Outcome Measures

Primary Outcomes (1)

  • the number of Circulating Tumor Cells

    The number of circulating tumor cells will be measured by collecting 5 ml of venous blood sample.

    on the Day 7~10 after surgery

Secondary Outcomes (5)

  • Surgeon Satisfaction

    immediately after surgery

  • Patient Satisfaction

    within 24 hours after surgery

  • Visual Analogue Scale

    at 24 hours after surgery

  • Nausea Score

    at 24 hours after surgery

  • Hospitalization Days

    up to 30 days

Study Arms (2)

General Anesthesia

ACTIVE COMPARATOR

Patients in this group will receive general anesthesia during TURBT.

Procedure: General Anesthesia

Spinal Anesthesia

EXPERIMENTAL

Patients in this group will receive spinal anesthesia during TURBT.

Procedure: Spinal Anesthesia

Interventions

General AnesthesiaPROCEDURE

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.

General Anesthesia
Spinal AnesthesiaPROCEDURE

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.

Spinal Anesthesia

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≤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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renji Hospital affliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200126, China

Location

MeSH Terms

Conditions

Urinary Bladder NeoplasmsNeoplastic Cells, Circulating

Interventions

Anesthesia, GeneralAnesthesia, Spinal

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesNeoplasm MetastasisNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and AnalgesiaAnesthesia, Conduction

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 9, 2023

First Posted

April 21, 2023

Study Start

August 15, 2023

Primary Completion

April 30, 2024

Study Completion

June 30, 2024

Last Updated

August 9, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)