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

Quality of Recovery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05356091
• Other study ID #: QRST
• Status: Completed
• Phase: N/A
• Start date: December 2, 2022
• Est. completion date: February 24, 2023

Study information

• Verified date: March 2023
• Source: Kangbuk Samsung Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: February 24, 2023
• Est. primary completion date: February 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Quality of Recovery

Intervention

Drug:
• Sevoflurane
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
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.

Locations

Country	Name	City	State
Korea, Republic of	Eunah Cho	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Kangbuk Samsung Hospital	Hana Pharm Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	postoperative day 1
Secondary	Catheter related bladder discomfort	Catheter related bladder discomfort is assessed as none, mild, moderate and severe.	5 minutes, and 1 hour after post-anesthesia circuit unit arrival.