NCT05376631

Brief Summary

The purpose of this study is to evaluate the effect of fresh gas flow on emergence time in patients undergoing transurethral resection of bladder tumor.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 17, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

May 20, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2022

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 17, 2022

Completed
Last Updated

August 18, 2022

Status Verified

August 1, 2022

Enrollment Period

3 months

First QC Date

May 9, 2022

Last Update Submit

August 16, 2022

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

  • Emergence time

    When consciousness and self respiration are fully recovered after surgery is ended, extubation is tried. The time to extubation (emergence time) is recorded.

    From end of surgery to extubation (assessed up to 30 minutes after surgery)

Secondary Outcomes (2)

  • Time to spontaneous movement

    From end of surgery to spontaneous movement (assessed up to 30 minutes after surgery)

  • Time to eye opening

    From end of surgery to eye opening (assessed up to 30 minutes after surgery)

Study Arms (2)

Group Five

ACTIVE COMPARATOR

For emergence from general anesthesia, a fresh gas flow of 5 L/min is used.

Procedure: Fresh gas flow of 5 L/min

Group Ten

EXPERIMENTAL

For emergence from general anesthesia, a fresh gas flow of 10 L/min is used.

Procedure: Fresh gas flow of 10 L/min

Interventions

Fresh gas flow of 5 L/minPROCEDURE

A fresh gas flow of 5 L/min is used during emergence from general anesthesia.

Group Five
Fresh gas flow of 10 L/minPROCEDURE

A fresh gas flow of 10 L/min is used during emergence from general anesthesia.

Group Ten

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who are scheduled transurethral resection of bladder tumor under general anesthesia
  • Patients aged between 20 and 79 years old
  • American Society of Anesthesiologists physical status ≤2
  • Patients who are voluntarily agreed to this clinical study

You may not qualify if:

  • A long operation (2 hours or longer)
  • Hearing disturbance
  • Cognitive disorder
  • Psychiatric substance abuse
  • Patient's denial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

Location

Related Publications (6)

  • Gaya da Costa M, Kalmar AF, Struys MMRF. Inhaled Anesthetics: Environmental Role, Occupational Risk, and Clinical Use. J Clin Med. 2021 Mar 22;10(6):1306. doi: 10.3390/jcm10061306.

    PMID: 33810063BACKGROUND

  • Brioni JD, Varughese S, Ahmed R, Bein B. A clinical review of inhalation anesthesia with sevoflurane: from early research to emerging topics. J Anesth. 2017 Oct;31(5):764-778. doi: 10.1007/s00540-017-2375-6. Epub 2017 Jun 5.

    PMID: 28585095BACKGROUND

  • Baum JA. Low-flow anesthesia: theory, practice, technical preconditions, advantages, and foreign gas accumulation. J Anesth. 1999;13(3):166-74. doi: 10.1007/s005400050050. No abstract available.

    PMID: 14530937BACKGROUND

  • Sakata DJ, Gopalakrishnan NA, Orr JA, White JL, Westenskow DR. Hypercapnic hyperventilation shortens emergence time from isoflurane anesthesia. Anesth Analg. 2007 Mar;104(3):587-91. doi: 10.1213/01.ane.0000255074.96657.39.

    PMID: 17312214BACKGROUND

  • Difficult Airway Society Extubation Guidelines Group; Popat M, Mitchell V, Dravid R, Patel A, Swampillai C, Higgs A. Difficult Airway Society Guidelines for the management of tracheal extubation. Anaesthesia. 2012 Mar;67(3):318-40. doi: 10.1111/j.1365-2044.2012.07075.x.

    PMID: 22321104BACKGROUND

  • Park JY, Yu J, Kim CS, Baek JW, Jo Y, Kim YK. Comparison of the effects of 5 and 10 L/minute fresh gas flow on emergence from sevoflurane anesthesia: A randomized clinical trial. Medicine (Baltimore). 2023 Jul 21;102(29):e34406. doi: 10.1097/MD.0000000000034406.

    PMID: 37478213DERIVED

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Young-Kug Kim, MD, PhD

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 9, 2022

First Posted

May 17, 2022

Study Start

May 20, 2022

Primary Completion

August 16, 2022

Study Completion

August 17, 2022

Last Updated

August 18, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)