Influence of Anesthesia Methods on CTCs in TURBT Patients

Sponsor

RenJi Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05824299

Collaborator

(none)

162

Enrollment

Location

Arms

13.9

Anticipated Duration (Months)

11.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Bladder Cancer	Procedure: General Anesthesia Procedure: Spinal Anesthesia	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

162 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Health Services Research

Official Title:

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

Anticipated Study Start Date :

May 4, 2023

Anticipated Primary Completion Date :

Apr 30, 2024

Anticipated Study Completion Date :

Jun 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: General Anesthesia Patients in this group will receive general anesthesia during TURBT.	Procedure: 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.
Experimental: Spinal Anesthesia Patients in this group will receive spinal anesthesia during TURBT.	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.

Arm

Intervention/Treatment

Active Comparator: General Anesthesia

Patients in this group will receive general anesthesia during TURBT.

Procedure: 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.

Experimental: Spinal Anesthesia

Patients in this group will receive spinal anesthesia during TURBT.

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.

Outcome Measures

Primary Outcome Measures

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

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.
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.
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.
Hospitalization Days [up to 30 days]
The length of hospital stay will be recorded.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Palliative or diagnostic procedure.
Recurrent bladder cancer.
History of surgery within 6 months.
Contraindications for spinal anesthesia.
Metastatic bladder cancer or with a history of any other malignancy.
Having received preoperative neoadjuvant therapy or is scheduled for postoperative chemoradiotherapy.
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.