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Quality of Recovery of Remimazolam Versus Sevoflurane in Transurethral Bladder Resection.

Comparison of Postoperative Recovery Quality Between Sevoflurane and Remimazolam for General Anesthesia for Transurethral Resection of Bladder Tumor

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05356091
Enrollment
36
Registered
2022-05-02
Start date
2022-12-02
Completion date
2023-02-24
Last updated
2023-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Quality of Recovery

Brief summary

This study was designated to investigate the quality of recovery after transurethral bladder resection. Because, patients undergoing transurethral bladder resection are mostly old age, and because of catheter-related bladder discomfort are common after transurethral bladder resection, study on the quality of recovery after transurethral bladder resection seems to be meaningful. In general, sevoflurane is commonly used as an anesthetic agent for general anesthesia of transurethral bladder resection. The purpose of this study is to investigate whether remimazolam is not inferior to sevoflurnane in terms of quality of recovery after transurethral bladder resection.

Interventions

DRUGSevoflurane

Sevoflurane is chosen as an anesthetic agent for general anesthesia. General anesthesia for the patients in this group will be induced with propofol (1-1.5 mg/kg), and will be maintained with sevoflurane to keep patient state index of 25-50.

DRUGRemimazolam

Remimazolam is chosen as an anesthetic agent for general anesthesia. General anesthesia for the patients in this group will be induced with remimazolam, and will be maintained with remimazolam to keep patient state index of 25-50.

Sponsors

Hana Pharm Co., Ltd.
CollaboratorINDUSTRY
Kangbuk Samsung Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* adult patients aged from 19 years * Americaln Society of Anesthesiologist's class I, II, and III * scheduled to undergo elective transurethral bladder resection under general anesthesia

Exclusion criteria

* refuse to participate in the study * cannot read, or sign the consent form (e.g., iliterate, foreigner, eye disease) * history of allergy to benzodiazepines * decreased liver, kidney, or heart function * pregnant women or breastfeeding patients * history of drug or alcohol abuse * obesity (body mass index \> 30kg/m2)

Design outcomes

Primary

MeasureTime frameDescription
Quality of recovery -15 score at postoperative day 1postoperative day 1Quality of recovery-15 questionnaire, which consists 15 questions. The score ranges from 0 to 150. The higher the score, the better the quality of recovery.

Secondary

MeasureTime frameDescription
Catheter related bladder discomfort5 minutes, and 1 hour after post-anesthesia circuit unit arrival.Catheter related bladder discomfort is assessed as none, mild, moderate and severe.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026