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Impact of Remimazolam on Prognosis After Bladder Cancer Surgery

Primary Purpose

Benzodiazepines, Bladder Cancer, Delirium

Status

Recruiting

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Remimazolam

Propofol

About this trial

This is an interventional prevention trial for Benzodiazepines focused on measuring Remimazolam, Bladder Cancer, Surgery, Emergence Delirium, Recurrence-free Survival

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Beijing Tsinghua Chang Gung HospitalRecruiting
The Sixth Medical Center of PLA General HospitalRecruiting
Peking University First HospitalRecruiting
Guizhou Provincial People's HospitalRecruiting
Jiangsu Provincial People's HospitalRecruiting
Shanghai 10th People's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Remimazolam group

Propofol group

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Recurrence-free survival (long-term).

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

Secondary Outcome Measures

Incidence of postoperative delirium (early).

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 (early).

Incidence of postoperative nausea and vomiting.

Incidence of intraoperative awareness (early).

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 (early).

Length of stay in hospital after surgery.

Incidence of non-delirium complications (early).

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.

All-cause 30-day mortality (early).

All-cause 30-day mortality.

Overall survival (long-term).

Time from surgery to all-cause death.

Event-free survival (long-term).

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 of 1-year survivors (long-term).

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.

Full Information

NCT ID

NCT04532606

First Posted

August 25, 2020

Last Updated

July 2, 2023

Sponsor

Peking University First Hospital

Collaborators

Beijing Tsinghua Chang Gung Hospital, Navy General Hospital, Beijing, Guizhou Provincial People's Hospital, Jiangsu Provincial People's Hospital, Shanghai 10th People's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04532606

Brief Title

Impact of Remimazolam on Prognosis After Bladder Cancer Surgery

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 5, 2021 (Actual)

Primary Completion Date

October 2024 (Anticipated)

Study Completion Date

October 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking University First Hospital

Collaborators

Beijing Tsinghua Chang Gung Hospital, Navy General Hospital, Beijing, Guizhou Provincial People's Hospital, Jiangsu Provincial People's Hospital, Shanghai 10th People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Benzodiazepines, Bladder Cancer, Delirium, Surgery, Cancer Recurrence

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

1128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Remimazolam group

Arm Type

Experimental

Arm Description

Arm Title

Propofol group

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Remimazolam

Other Intervention Name(s)

Remimazolam anesthesia

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Propofol

Other Intervention Name(s)

Propofol anesthesia

Intervention Description

Primary Outcome Measure Information:

Title

Incidence of emergence delirium (early).

Description

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 Frame

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

Title

Recurrence-free survival (long-term).

Description

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

Time Frame

Up to 3 years after surgery.

Secondary Outcome Measure Information:

Title

Incidence of postoperative delirium (early).

Description

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

Time Frame

During the first 3 days after surgery.

Title

Incidence of postoperative nausea and vomiting (early).

Description

Incidence of postoperative nausea and vomiting.

Time Frame

Up to 24 hours after surgery.

Title

Incidence of intraoperative awareness (early).

Description

Time Frame

Up to 1 day after surgery.

Title

Length of stay in hospital after surgery (early).

Description

Length of stay in hospital after surgery.

Time Frame

Up to 30 days after surgery.

Title

Incidence of non-delirium complications (early).

Description

Time Frame

Up to 30 days after surgery.

Title

All-cause 30-day mortality (early).

Description

All-cause 30-day mortality.

Time Frame

Up to 30 days after surgery.

Title

Overall survival (long-term).

Description

Time from surgery to all-cause death.

Time Frame

Up to 3 years after surgery.

Title

Event-free survival (long-term).

Description

Time Frame

Up to 3 years after surgery.

Title

Health related quality of life of 1-year survivors (long-term).

Description

Time Frame

At the end of the 1st year after surgery.

Other Pre-specified Outcome Measures:

Title

Intensity of pain (early).

Description

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).

Time Frame

During the first 3 days after surgery.

Title

Subjective sleep quality (early).

Description

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).

Time Frame

During the first 3 days after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Wang Dong-Xin, MD, PhD

Phone

86 10 83572784

wangdongxin@hotmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Zhang Yu-Xiu, MD

Phone

+86 15201190755

zhangyuxiu1992@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wang Dong-Xin, MD, PhD

Organizational Affiliation

Peking University First Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Beijing Tsinghua Chang Gung Hospital

City

Beijing

State/Province

Beijing

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Huan Zhang, MD

Facility Name

The Sixth Medical Center of PLA General Hospital

City

Beijing

State/Province

Beijing

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jun Li, MD

Facility Name

Peking University First Hospital

City

Beijin

State/Province

Bejing

ZIP/Postal Code

100034

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wang Dong-Xin, MD, PhD

Phone

86(10) 83572784

wangdongxin@hotmail.com

First Name & Middle Initial & Last Name & Degree

Zhang Yu-Xiu, MD

Phone

+86 15201190755

zhangyuxiu1992@163.com

Facility Name

Guizhou Provincial People's Hospital

City

Guiyang

State/Province

Guizhou

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fang-Xiang Zhang, MD

Facility Name

Jiangsu Provincial People's Hospital

City

Nanjing

State/Province

Jiangsu

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Cun-Ming Liu, MD

Facility Name

Shanghai 10th People's Hospital

City

Shanghai

State/Province

Shanghai

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xuan Zhao, MD

12. IPD Sharing Statement

Plan to Share IPD

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Impact of Remimazolam on Prognosis After Bladder Cancer Surgery

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