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OpenTrials
Completed

NCT Number: NCT05356091

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

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.

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Key information

Conditions

Quality of Recovery

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eunah Cho

Seoul, 03181, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Sevoflurane

Drug

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.

Remimazolam

Drug

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.

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

  1. Catheter related bladder discomfort

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

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

Sponsors and collaborators

Lead sponsor

Kangbuk Samsung Hospital

Other

Collaborators

  • Hana Pharm Co., Ltd.

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 2, 2022
Registry last updated
Mar 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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