Back to resultsEffect of Fresh Gas Flow on Emergence Time
Primary Purpose
Bladder Cancer
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Fresh gas flow of 5 L/min
Fresh gas flow of 10 L/min
Sponsored by
About this trial
This is an interventional other trial for Bladder Cancer
Eligibility Criteria
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
Sites / Locations
- Asan Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Group Five
Group Ten
Arm Description
For emergence from general anesthesia, a fresh gas flow of 5 L/min is used.
For emergence from general anesthesia, a fresh gas flow of 10 L/min is used.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05376631
Brief Title
Effect of Fresh Gas Flow on Emergence Time
Official Title
Effect of Fresh Gas Flow on Emergence Time in the Patients Undergoing Transurethral Resection of Bladder Tumor: A Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
May 20, 2022 (Actual)
Primary Completion Date
August 16, 2022 (Actual)
Study Completion Date
August 17, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group Five
Arm Type
Active Comparator
Arm Description
For emergence from general anesthesia, a fresh gas flow of 5 L/min is used.
Arm Title
Group Ten
Arm Type
Experimental
Arm Description
For emergence from general anesthesia, a fresh gas flow of 10 L/min is used.
Intervention Type
Procedure
Intervention Name(s)
Fresh gas flow of 5 L/min
Intervention Description
A fresh gas flow of 5 L/min is used during emergence from general anesthesia.
Intervention Type
Procedure
Intervention Name(s)
Fresh gas flow of 10 L/min
Intervention Description
A fresh gas flow of 10 L/min is used during emergence from general anesthesia.
Primary Outcome Measure Information:
Title
Emergence time
Description
When consciousness and self respiration are fully recovered after surgery is ended, extubation is tried. The time to extubation (emergence time) is recorded.
Time Frame
From end of surgery to extubation (assessed up to 30 minutes after surgery)
Secondary Outcome Measure Information:
Title
Time to spontaneous movement
Description
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.
Time Frame
From end of surgery to spontaneous movement (assessed up to 30 minutes after surgery)
Title
Time to eye opening
Description
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.
Time Frame
From end of surgery to eye opening (assessed up to 30 minutes after surgery)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young-Kug Kim, MD, PhD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33810063
Citation
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.
Results Reference
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PubMed Identifier
28585095
Citation
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.
Results Reference
background
PubMed Identifier
14530937
Citation
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.
Results Reference
background
PubMed Identifier
17312214
Citation
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.
Results Reference
background
PubMed Identifier
22321104
Citation
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.
Results Reference
background
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Effect of Fresh Gas Flow on Emergence Time
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