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

NCT ID: NCT05356091

Last Updated: 2023-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-02
• Study Completion Date: 2023-02-24

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.

Conditions

Quality of Recovery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Sevoflurane

General anesthesia using sevoflurane

Group Type: ACTIVE_COMPARATOR

Sevoflurane

Intervention Type: 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

General anesthesia using remimazolam

Group Type: EXPERIMENTAL

Remimazolam

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hana Pharm Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Kangbuk Samsung Hospital

OTHER

Sponsor Role: lead

Responsible Party

Eunah Cho, MD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eunah Cho, Pf.

Role: PRINCIPAL_INVESTIGATOR

KangbukSamsung Hospital

Locations

Eunah Cho

Seoul, , South Korea

Countries

South Korea

Other Identifiers

QRST

Identifier Type: -

Identifier Source: org_study_id