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CompletedNCT05356091Updated Mar 9, 2023

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

An interventional study of Sevoflurane and Remimazolam in Quality of Recovery, sponsored by Kangbuk Samsung Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2023-03-09.

Sponsored by Kangbuk Samsung Hospital · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Quality of Recovery
03

In context

Lead sponsor

Kangbuk Samsung Hospital is the lead sponsor of 59 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts 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

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)
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
36 participants (actual)

Study arms

  • Active comparator
    Sevoflurane

    General anesthesia using sevoflurane

    Drug: Sevoflurane

  • Experimental
    Remimazolam

    General anesthesia using remimazolam

    Drug: Remimazolam

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.

06

What researchers measure

Primary outcomes

  1. Quality of recovery -15 score at postoperative day 1

    Quality 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.

    Time frame: postoperative day 1

Secondary outcomes

  1. Catheter related bladder discomfort

    Catheter related bladder discomfort is assessed as none, mild, moderate and severe.

    Time frame: 5 minutes, and 1 hour after post-anesthesia circuit unit arrival.

07

Study locations

1 site
  • Eunah Cho
    Seoul, 03181, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 9, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05356091
Lead sponsor
Kangbuk Samsung Hospital
Collaborators
Hana Pharm Co., Ltd.
Responsible party
Eunah Cho, MD (Assistant Professor, Kangbuk Samsung Hospital) — Principal investigator
First posted
May 2, 2022
Start date
Dec 2, 2022
Primary completion
Feb 24, 2023
Completion
Feb 24, 2023
Last update
Mar 9, 2023

Study contacts

Eunah Cho, Pf.
principal investigator · KangbukSamsung Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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