Impact of Remimazolam on Prognosis After Bladder Cancer Surgery

NCT04532606 | Recruiting Phase 4 DMC

• 1 other identifier: 2020-212
• Study Type: interventional
• Target: 1,128
• Locations: 1 country
• Sites: 6

Brief Summary

Bladder cancer is one of the most common genitourinary cancers. Transurethral resection of bladder tumor (TURBT) is the standard therapy for nonmuscle invasive bladder cancer. However, patients after TURBT are at risk for recurrence and progression. Benzodiazepines are proved to inhibit proliferation of multiple types of cancer cells in vitro. Delirium is an acute onset and transient cerebral dysfunction and is associated with worse outcomes. Previous studies indicated that benzodiazepines increase incidence of postoperative delirium. Remimazolam is a new benzodiazepine with rapid onset and ultra-short activity. The aims of this study are to explore the impact of remimazolam for general anesthesia on emergency delirium and recurrence-free survival in patients undergoing bladder cancer surgery.

Conditions

Benzodiazepines; Bladder Cancer; Delirium; Surgery; Cancer Recurrence

Keywords

Remimazolam; Bladder Cancer; Surgery; Emergence Delirium; Recurrence-free Survival

Outcome Measures

Primary Outcomes (2)

• Incidence of emergence delirium (early).

  Emergence delirium is assessed with the Confusion Assessment Method for the Intensive Care Unit at 10 and 30 minutes after admission to the post-anesthesia care unit after surgery.

  Up to 2 hours during the stay in post-anesthesia care unit after surgery.

• Recurrence-free survival (long-term).

  Time from surgery to recurrence/metastasis or all-cause death, whichever come first.

  Up to 3 years after surgery.

Secondary Outcomes (9)

• Incidence of postoperative delirium (early).

  During the first 3 days after surgery.

• Incidence of postoperative nausea and vomiting (early).

  Up to 24 hours after surgery.

• Incidence of intraoperative awareness (early).

  Up to 1 day after surgery.

• Length of stay in hospital after surgery (early).

  Up to 30 days after surgery.

• Incidence of non-delirium complications (early).

  Up to 30 days after surgery.

Other Outcomes (2)

• Intensity of pain (early).

  During the first 3 days after surgery.

• Subjective sleep quality (early).

  During the first 3 days after surgery

Study Arms (2)

Remimazolam group

EXPERIMENTAL

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.

Drug: Remimazolam

Propofol group

ACTIVE COMPARATOR

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.

Drug: Propofol

Interventions

Remimazolam DRUG

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.

Also known as: Remimazolam anesthesia

Remimazolam group

Propofol DRUG

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.

Also known as: Propofol anesthesia

Propofol group

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥50 years and \<90 years;
• Preoperative diagnosis is non-muscle-invasive bladder cancer(Ta-T1);
• Scheduled to undergo transurethral resection of bladder tumor;
• Agree to participate, and provide written informed consent.

You may not qualify if:

• Refuse to participate;
• Emergent surgery;
• Combined with other malignant tumors;
• Use of benzodiazepines for 1 week within the last month before surgery;
• Preoperative history of schizophrenia, epilepsy, parkinsonism or myasthenia gravis;
• Inability to communicate in the preoperative period due to coma, profound dementia, language barrier, or end-stage disease;
• 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);
• The purpose of surgery is to make a diagnosis or preoperative judgement is that tumor cannot be completely removed.

Sponsors & Collaborators

• Peking University First Hospital: lead
• Beijing Tsinghua Chang Gung Hospital: collaborator
• Navy General Hospital, Beijing: collaborator
• Guizhou Provincial People's Hospital: collaborator
• Jiangsu Provincial People's Hospital: collaborator
• Shanghai 10th People's Hospital: collaborator

Study Sites (6)

Beijing Tsinghua Chang Gung Hospital

Beijing, Beijing Municipality, China

RECRUITING

The Sixth Medical Center of PLA General Hospital

Beijing, Beijing Municipality, China

RECRUITING

Peking University First Hospital

Beijin, Bejing, 100034, China

RECRUITING

Guizhou Provincial People's Hospital

Guiyang, Guizhou, China

RECRUITING

Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, China

RECRUITING

Shanghai 10th People's Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

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MeSH Terms

Conditions

Urinary Bladder Neoplasms; Delirium; Emergence Delirium

Interventions

remimazolam; Propofol

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Wang Dong-Xin, MD, PhD

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wang Dong-Xin, MD, PhD

CONTACT

86 10 83572784; wangdongxin@hotmail.com

Zhang Yu-Xiu, MD

CONTACT

+86 15201190755; zhangyuxiu1992@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 25, 2020
• First Posted: August 31, 2020
• Study Start: February 5, 2021
• Primary Completion: October 1, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)