Impact of Remimazolam on Prognosis After Bladder Cancer Surgery
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age50-90
SponsorPeking University First Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Refuse to participate;
Emergent surgery;
Combined with other malignant tumors;
Use of benzodiazepines for 1 week within the last month before surgery;
Trial design
Design model
Parallel
Treatments tested in this trial
Remimazolam
DrugRemimazolam 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
DrugPropofol 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.
Treatment groups
1,128 Participants
are divided into 2 treatment groupsGroup A: Remimazolam groupExperimental treatment 1 intervention
Group B: Propofol groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Up to 2 hours during the stay in post-anesthesia care unit after surgery.2
Recurrence-free survival (long-term).
Time from surgery to recurrence/metastasis or all-cause death, whichever come first.
Time frame
Up to 3 years after surgery.Secondary outcomes
1
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.
Time frame
During the first 3 days after surgery.2
Incidence of postoperative nausea and vomiting (early).
Incidence of postoperative nausea and vomiting.
Time frame
Up to 24 hours after surgery.3
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?
Time frame
Up to 1 day after surgery.4
Length of stay in hospital after surgery (early).
Length of stay in hospital after surgery.
Time frame
Up to 30 days after surgery.Other outcomes
1
Intensity of pain (early).
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.2
Subjective sleep quality (early).
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 surgerySponsors and contacts
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Peking University First Hospital
Lead sponsor
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
Source ClinicalTrials.gov