Nervous System Diseases

Symptoms and General Pathology

Behaviors and Mental Disorders

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Delirium

Emergence Delirium

Recurrence

Urinary Bladder Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Disease Attributes

Confusion

Neurobehavioral Manifestations

Neurologic Manifestations

Neurocognitive Disorders

Mental Disorders

Psychotic Disorders

Central Nervous System Depressants

All Drugs and Chemicals

Platelet Aggregation Inhibitors

Adjuvants, Anesthesia

Analgesics

Other Dietary Supplements

Anesthetics

Rocuronium

Propofol

Sevoflurane

Sufentanil

Remifentanil

Benzocaine

Cisatracurium

Dsuvia

Hypnotics and Sedatives

Anesthetics, Intravenous

Anesthetics, General

Tannic Acid

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.

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.

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.

Remimazolam

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.

Wang Dong-Xin, MD, PhD

Zhang Yu-Xiu, MD

Huan Zhang, MD

Jun Li, MD

Fang-Xiang Zhang, MD

Cun-Ming Liu, MD

Xuan Zhao, MD

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.

Bladder cancer is one of the most common genitourinary cancers. Approximately 70-80% of bladder cancers are nonmuscle invasive, including those of Ta-T1 stage and carcinoma in situ. Transurethral resection of bladder tumor (TURBT) is the standard therapy for nonmuscle invasive bladder cancer. However, patients after TURBT are at a high risk of recurrence and progression.

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.

Impact of Remimazolam on Prognosis After Bladder Cancer Surgery

Impact of Remimazolam Tosilate for General Anesthesia on Prognosis After Bladder Cancer Surgery: a Randomized Controlled Trial

Assessed twice daily (8-10 am and 18-20 pm) with the Numeric Rating Scale (NRS; an 11-point scale where 0=no pain and 10=the worst pain).

Assessed in the morning (8-10 am) with the Numeric Rating Scale (NRS; an 11-point scale where 0=the best sleep and 10=the worst sleep).

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.

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

Delirium is assessed twice daily with the Chinese version of the 3-minute diagnostic interview for Confusion Assessment Method-defined delirium.

Incidence of postoperative nausea and vomiting.

Intraoperative awareness is assessed with modified Brice interview before discharge from the post-anesthesia care unit and on the 1st day after surgery. The interview included five questions: (1) What was the last thing you remembered happening before you went to sleep? (2) What is the first thing you remember after your operation? (3) Can you remember anything in between? (4) Can you remember if you had any dreams during your operation? (5) What was the worst thing about your operation?

Length of stay in hospital after surgery.

Non-delirium complications are defined as newly occurred medical conditions other than delirium that are harmful for patients' recovery and required therapeutic intervention, i.e., grade 2 or higher on Clavien-Dindo classification.

Time from surgery to serious events, cancer recurrence/metastasis, or all-cause death, whichever come first. Serious events are defined as any new onset disease that required hospitalization and/or surgical intervention.

Health related quality of life is assessed with the World Health Organization Quality of Life-brief version (WHOQOL-BREF) which is a 24-item questionnaire that assesses the quality of life in physical, psychological, and social relationship, and environmental domains. The score ranges from 0 to 100 for each domain, with higher score indicating better function.

Beijing Tsinghua Chang Gung Hospital

Navy General Hospital, Beijing

Guizhou Provincial People's Hospital

Jiangsu Provincial People's Hospital

Shanghai 10th People's Hospital

Peking University First Hospital

Professor

Cognitive Dysfunction

Postoperative Cognitive Complications

Cognition Disorders

Postoperative Complications

Psychotropic Drugs

Fentanyl

Midazolam

Analgesics, Opioid

Anti-Anxiety Agents

GABA Modulators

Neurotransmitter Agents

Narcotics

spinal anesthesia premedication with benzodiazepine and opioid

spinal anesthesia premedication with opioid

benzodiazepines

opioid

spinal anesthesia

Karolina Dobronska, MD

Lidia I Jureczko, PhD MD

This study evaluates the influence of premedication on cognitive functions in patients undergoing transurethral resection of bladder tumor under spinal anesthesia. The aims of premedication are anxiolysis, analgesia and the reduction of perioperative risk among the patients with comorbidities. The patients will be randomly allocated to receive premedication either with opioid solely or with benzodiazepine combined with opioid. The anesthetic technique is standardized.

Trans-urethral resection of bladder tumor (TURBT) is the basic endoscopic procedure for management of bladder cancer and if there are no contraindications, it is performed under spinal anesthesia. The condition usually occurs among elderly patients, every 9 of 10 is older than 55 years. At this age the postoperative cognitive dysfunction (POCD) is a common complication as the risk increases with age. There are some studies indicating that using benzodiazepines during the perioperative period can also increase the number of registered POCD in patients undergoing anesthesia. Postoperative cognitive dysfunction (POCD) occurs after operations under regional and general anesthesia as well. The study was planed to evaluate the risk of POCD among urological patients and to asses whether combining benzodiazepines with opioids for premedication increases this risk.

The participants after giving the informed consent can participate in the study. The Beck Depression Inventory is performed to rule out the patients with depression. The cognitive functions are tested with Montreal Cognitive Assessment before the surgery and subsequently in the first 24 hours after surgery, three weeks later (while patients come back to receive histopathological examination), and finally six months after surgery (during control cystoscopy).

During anesthesia, the patients will be randomly allocated to receive premedication either with opioid solely or with benzodiazepine combined with opioid. The anesthetic technique is standardized. If the premedication is needed before the surgery the hydroxyzine will be administrated.

the participant is not performed about the type of premedication performed

The Assessment of POCD After TURBT Under Spinal Anesthesia

The Assessment of Postoperative Cognitive Dysfunction After Transurethral Resection of Bladder Tumor Under Spinal Anesthesia

evaluated by Montreal Cognitive Assesment

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Impact of Remimazolam on Prognosis After Bladder Cancer Surgery	NCT04532606	Benzodiazepines Bladder Cancer Delirium Surgery Cancer Recurren...	Remimazolam Propofol	50 Years - 90 Years	Peking University First Hospital
The Assessment of POCD After TURBT Under Spinal Anesthesia	NCT03029676	Bladder Tumor Postoperative C...	benzodiazepines opioid spinal anesthes...	18 Years -	Medical University of Warsaw
Impact of Remimazolam on Prognosis After Bladder Cancer Surgery	NCT04532606	Benzodiazepines Bladder Cancer Delirium Surgery Cancer Recurren...	Remimazolam Propofol	50 Years - 90 Years	Peking University First Hospital

Spots Global Cancer Trial Database for benzodiazepines