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

March 7, 2023 updated by: Eunah Cho, MD, Kangbuk Samsung Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sevoflurane
General anesthesia using sevoflurane
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.
Experimental: Remimazolam
General anesthesia using remimazolam
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
postoperative day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 minutes, and 1 hour after post-anesthesia circuit unit arrival.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kangbuk Samsung Hospital

Collaborators

Hana Pharm Co., Ltd.

Investigators

  • Principal Investigator: Eunah Cho, Pf., Kangbuksamsung Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2022

Primary Completion (Actual)

February 24, 2023

Study Completion (Actual)

February 24, 2023

Study Registration Dates

First Submitted

April 24, 2022

First Submitted That Met QC Criteria

April 27, 2022

First Posted (Actual)

May 2, 2022

Study Record Updates

Last Update Posted (Estimate)

March 9, 2023

Last Update Submitted That Met QC Criteria

March 7, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QRST

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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