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

Sponsor

Kangbuk Samsung Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05356091

Collaborator

Hana Pharm. Co., Ltd (Other)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Quality of Recovery	Drug: Sevoflurane Drug: Remimazolam	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Quality of recovery -15 score at postoperative day 1 [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 Outcome Measures

Catheter related bladder discomfort [5 minutes, and 1 hour after post-anesthesia circuit unit arrival.]
Catheter related bladder discomfort is assessed as none, mild, moderate and severe.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Kangbuk Samsung Hospital
Hana Pharm. Co., Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Eunah Cho, MD, Assistant Professor, Kangbuk Samsung Hospital

ClinicalTrials.gov Identifier:

NCT05356091

Other Study ID Numbers:

QRST

First Posted:

May 2, 2022

Last Update Posted:

May 2, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Sevoflurane

Study Results

No Results Posted as of May 2, 2022