Effect of Fresh Gas Flow on Emergence Time

Effect of Fresh Gas Flow on Emergence Time in the Patients Undergoing Transurethral Resection of Bladder Tumor: A Randomized Controlled Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Bladder Cancer
• Intervention / Treatment: Procedure: Fresh gas flow of 5 L/min; Procedure: Fresh gas flow of 10 L/min

Detailed Description

The purpose of this study is to evaluate the effect of fresh gas flow (5 L/min vs. 10 L/min) on emergence time in patients undergoing transurethral resection of bladder tumor.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group Five; For emergence from general anesthesia, a fresh gas flow of 5 L/min is used.	Procedure: Fresh gas flow of 5 L/min; A fresh gas flow of 5 L/min is used during emergence from general anesthesia.
Experimental: Group Ten; For emergence from general anesthesia, a fresh gas flow of 10 L/min is used.	Procedure: Fresh gas flow of 10 L/min; A fresh gas flow of 10 L/min is used during emergence from general anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to spontaneous movement	After surgery is stopped, the patients are asked to open their eyes every 1 minute after the termination of sevoflurane administration. The time to spontaneous movement is recorded.	From end of surgery to spontaneous movement (assessed up to 30 minutes after surgery)
Time to eye opening	After surgery is stopped, the patients are asked to open their eyes every 1 minute after the termination of sevoflurane administration. The time to eye opening is recorded.	From end of surgery to eye opening (assessed up to 30 minutes after surgery)

Collaborators and Investigators

• Sponsor: Asan Medical Center

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2022
• Primary Completion (Actual): August 16, 2022
• Study Completion (Actual): August 17, 2022

Study Registration Dates

• First Submitted: May 9, 2022
• First Submitted That Met QC Criteria: May 11, 2022
• First Posted (Actual): May 17, 2022

Study Record Updates

• Last Update Posted (Actual): August 18, 2022
• Last Update Submitted That Met QC Criteria: August 16, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: 2022-0606

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No