Back to resultsInfluence of Anesthesia Methods on CTCs in TURBT Patients
Primary Purpose
Bladder Cancer
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
General Anesthesia
Spinal Anesthesia
Sponsored by
About this trial
This is an interventional health services research trial for Bladder Cancer focused on measuring Circulating Tumor Cells, General Anesthesia, Spinal Anesthesia, Transurethral Resection of Bladder Tumor
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.
Sites / Locations
- Renji Hospital affliated to Shanghai Jiaotong University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
General Anesthesia
Spinal Anesthesia
Arm Description
Patients in this group will receive general anesthesia during TURBT.
Patients in this group will receive spinal anesthesia during TURBT.
Outcomes
Primary Outcome Measures
the number of Circulating Tumor Cells
The number of circulating tumor cells will be measured by collecting 5 ml of venous blood sample.
Secondary Outcome Measures
Surgeon Satisfaction
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
The patient satisfaction will be measured with the Modified Bauer Scale, which ranges from 0 to 50, with a higher score indicating higher satisfaction.
Visual Analogue Scale
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.
Nausea Score
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.
Hospitalization Days
The length of hospital stay will be recorded.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05824299
Brief Title
Influence of Anesthesia Methods on CTCs in TURBT Patients
Official Title
Influence of General Anesthesia Versus Spinal Anesthesia on Circulating Tumor Cells in Patients Undergoing Transurethral Resection of Bladder Tumor
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 15, 2023 (Anticipated)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
RenJi Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
Keywords
Circulating Tumor Cells, General Anesthesia, Spinal Anesthesia, Transurethral Resection of Bladder Tumor
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
162 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
General Anesthesia
Arm Type
Active Comparator
Arm Description
Patients in this group will receive general anesthesia during TURBT.
Arm Title
Spinal Anesthesia
Arm Type
Experimental
Arm Description
Patients in this group will receive spinal anesthesia during TURBT.
Intervention Type
Procedure
Intervention Name(s)
General Anesthesia
Intervention Description
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
Intervention Name(s)
Spinal Anesthesia
Intervention Description
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.
Primary Outcome Measure Information:
Title
the number of Circulating Tumor Cells
Description
The number of circulating tumor cells will be measured by collecting 5 ml of venous blood sample.
Time Frame
on the Day 7~10 after surgery
Secondary Outcome Measure Information:
Title
Surgeon Satisfaction
Description
The surgeon satisfaction will be measured with the Likert scale, which ranges from 0 to 50, with a higher score indicating higher satisfaction.
Time Frame
immediately after surgery
Title
Patient Satisfaction
Description
The patient satisfaction will be measured with the Modified Bauer Scale, which ranges from 0 to 50, with a higher score indicating higher satisfaction.
Time Frame
within 24 hours after surgery
Title
Visual Analogue Scale
Description
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.
Time Frame
at 24 hours after surgery
Title
Nausea Score
Description
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.
Time Frame
at 24 hours after surgery
Title
Hospitalization Days
Description
The length of hospital stay will be recorded.
Time Frame
up to 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Renji Hospital affliated to Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200126
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
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Influence of Anesthesia Methods on CTCs in TURBT Patients
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