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

NCT05356091 | Completed

• 1 other identifier: QRST
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Outcome Measures

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.

  postoperative day 1

Secondary Outcomes (1)

• Catheter related bladder discomfort

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

Study Arms (2)

Sevoflurane

ACTIVE COMPARATOR

General anesthesia using sevoflurane

Drug: Sevoflurane

Remimazolam

EXPERIMENTAL

General anesthesia using remimazolam

Drug: Remimazolam

Interventions

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.

Sevoflurane

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.

Remimazolam

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Kangbuk Samsung Hospital: lead
• Hana Pharm Co., Ltd.: collaborator

Study Sites (1)

Eunah Cho

Seoul, 03181, South Korea

Location

MeSH Terms

Interventions

Sevoflurane; remimazolam

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Study Officials

• Eunah Cho, Pf.

  KangbukSamsung Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 24, 2022
• First Posted: May 2, 2022
• Study Start: December 2, 2022
• Primary Completion: February 24, 2023
• Study Completion: February 24, 2023
• Last Updated: March 9, 2023

Record last verified: 2023-03

Locations

KR (1)