Impact of Remimazolam on Prognosis After Bladder Cancer Surgery
NCT ID: NCT04532606
Last Updated: 2025-07-30
Study Results
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Basic Information
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RECRUITING
PHASE4
1128 participants
INTERVENTIONAL
2021-02-05
2026-10-31
Brief Summary
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Detailed Description
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Recently, impacts of anesthetic agents on tumor cells have attracted more attention. Benzodiazepines are found to inhibit proliferation of lymphoma, neural tumor, lung cancer, rectal cancer and breast cancer cells in vitro. Midazolam may have anti-tumor effects through induction of apoptosis and inhibition of inflammatory reaction. However, clinical evidence regarding effects of benzodiazepines on outcomes after cancer surgery remains lacking.
Remimazolam is a new benzodiazepine with rapid onset and ultra-short activity. It is rapidly metabolized by tissue esterases to inactive metabolite and can be reversed by flumazenil. Therefore, patients wake up rapidly even after prolonged infusions. It is also found to produce less respiratory and circulatory depression when compared with propofol.
Delirium is an acute onset and transient cerebral dysfunction, and is associated with worse outcomes including prolonged hospitalization, worse functional recovery, cognitive decline, and increased mortality rate. Previous studies indicated that benzodiazepines increase incidence of postoperative delirium, possibly due to prolonged action. With the property of ultra-short activity, remimazolam may not increase the incidence of delirium. But evidence is lacking in this aspect.
The aims of this study are to explore the impact of remimazolam on emergency delirium and recurrence-free survival in patients undergoing bladder cancer surgery.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Remimazolam group
Remimazolam is administered intravenously for anesthesia induction and maintenance. The dose and infusion rate is adjusted to maintain Bispectral Index (BIS) value between 40 and 60. Analgesia is maintained with remifentanil and/or sufentanil. Muscle relaxation is maintained with rocuronium and/or cisatracurium. Sevoflurane inhalation is provided when considered necessary.
Remimazolam
Remimazolam is administered intravenously for anesthesia induction and maintenance. The dose and infusion rate is adjusted to maintain BIS value between 40 and 60. Analgesia is maintained with remifentanil and/or sufentanil. Muscle relaxation is maintained with rocuronium and/or cisatracurium. Sevoflurane inhalation is provided when considered necessary.
Propofol group
Propofol is administered intravenously for anesthesia induction and maintenance. The dose and infusion rate is adjusted to maintain BIS value between 40 and 60. Analgesia is maintained with remifentanil and/or sufentanil. Muscle relaxation is maintained with rocuronium and/or cisatracurium. Sevoflurane inhalation is provided when considered necessary.
Propofol
Propofol is administered intravenously for anesthesia induction and maintenance. The dose and infusion rate is adjusted to maintain BIS value between 40 and 60. Analgesia is maintained with remifentanil and/or sufentanil. Muscle relaxation is maintained with rocuronium and/or cisatracurium. Sevoflurane is provided when considered necessary.
Interventions
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Remimazolam
Remimazolam is administered intravenously for anesthesia induction and maintenance. The dose and infusion rate is adjusted to maintain BIS value between 40 and 60. Analgesia is maintained with remifentanil and/or sufentanil. Muscle relaxation is maintained with rocuronium and/or cisatracurium. Sevoflurane inhalation is provided when considered necessary.
Propofol
Propofol is administered intravenously for anesthesia induction and maintenance. The dose and infusion rate is adjusted to maintain BIS value between 40 and 60. Analgesia is maintained with remifentanil and/or sufentanil. Muscle relaxation is maintained with rocuronium and/or cisatracurium. Sevoflurane is provided when considered necessary.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Preoperative diagnosis is non-muscle-invasive bladder cancer(Ta-T1);
3. Scheduled to undergo transurethral resection of bladder tumor;
4. Agree to participate, and provide written informed consent.
Exclusion Criteria
2. Emergent surgery;
3. Combined with other malignant tumors;
4. Use of benzodiazepines for 1 week within the last month before surgery;
5. Preoperative history of schizophrenia, epilepsy, parkinsonism or myasthenia gravis;
6. Inability to communicate in the preoperative period due to coma, profound dementia, language barrier, or end-stage disease;
7. Critical illness (preoperative American Society of Anesthesiologists physical status classification ≥IV), severe hepatic dysfunction (Child-Pugh class C), or severe renal dysfunction (undergoing dialysis before surgery);
8. The purpose of surgery is to make a diagnosis or preoperative judgement is that tumor cannot be completely removed.
50 Years
90 Years
ALL
No
Sponsors
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Beijing Tsinghua Chang Gung Hospital
OTHER
Navy General Hospital, Beijing
OTHER
Guizhou Provincial People's Hospital
OTHER
Jiangsu Provincial People's Hospital
OTHER
Shanghai 10th People's Hospital
OTHER
Peking University First Hospital
OTHER
Responsible Party
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Dong-Xin Wang
Professor
Principal Investigators
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Wang Dong-Xin, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Peking University First Hospital
Locations
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Beijing Tsinghua Chang Gung Hospital
Beijing, Beijing Municipality, China
The Sixth Medical Center of PLA General Hospital
Beijing, Beijing Municipality, China
Peking University First Hospital
Beijin, Bejing, China
Guizhou Provincial People's Hospital
Guiyang, Guizhou, China
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, China
Shanghai 10th People's Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Huan Zhang, MD
Role: primary
Jun Li, MD
Role: primary
Fang-Xiang Zhang, MD
Role: primary
Cun-Ming Liu, MD
Role: primary
Xuan Zhao, MD
Role: primary
References
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Other Identifiers
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2020-212
Identifier Type: -
Identifier Source: org_study_id
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