Bladder CancerNCT05376631
Effect of Fresh Gas Flow on Emergence Time
A study testing Fresh gas flow of 5 L/min and Fresh gas flow of 10 L/min in people with Bladder Cancer, run by Asan Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Fresh gas flow of 5 L/min and Fresh gas flow of 10 L/min
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 May 2022to 17 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- A long operation (2 hours or longer)
- Hearing disturbance
- Cognitive disorder
- Psychiatric substance abuse
- Patient's denial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Bladder Cancer
- Being tested
- Fresh gas flow of 5 L/min, Fresh gas flow of 10 L/min
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fresh gas flow of 5 L/minProcedure or surgery
A fresh gas flow of 5 L/min is used during emergence from general anesthesia.
Fresh gas flow of 10 L/minProcedure or surgery
A fresh gas flow of 10 L/min is used during emergence from general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Group Five | Active comparator | For emergence from general anesthesia, a fresh gas flow of 5 L/min is used. Receives: 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. Receives: Procedure: Fresh gas flow of 10 L/min |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From end of surgery to extubation (assessed up to 30 minutes after surgery)
Secondary outcomes (2)
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.
Measured: 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.
Measured: From end of surgery to eye opening (assessed up to 30 minutes after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start20 May 2022
- Primary completion16 Aug 2022
- Study completion17 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young-Kug Kim, MD, Asan Medical Center
- Investigators
- Young-Kug Kim, MD, PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05376631
- Sponsor's protocol ID
- 2022-0606
- Status last verified
- Aug 2022
- First submitted
- 9 May 2022
- Last updated
- 18 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33810063Brioni 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.
PubMed 28585095Baum 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.
PubMed 14530937Sakata 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.
PubMed 17312214Difficult 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.
PubMed 22321104Park 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.
PubMed 37478213
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Fresh Gas Flow on Emergence Time in the Patients Undergoing Transurethral Resection of Bladder Tumor: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05376631
- Acronym / sponsor ID
- 2022-0606
- Conditions
- Bladder Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 20 May 2022 (actual)
- Primary completion
- 16 Aug 2022 (actual)
- Study completion
- 17 Aug 2022 (actual)
- First posted
- 17 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Five | Active comparator | Procedure: Fresh gas flow of 5 L/minFor emergence from general anesthesia, a fresh gas flow of 5 L/min is used. |
| Group Ten | Experimental | Procedure: Fresh gas flow of 10 L/minFor emergence from general anesthesia, a fresh gas flow of 10 L/min is used. |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- A long operation (2 hours or longer)
- Hearing disturbance
- Cognitive disorder
- Psychiatric substance abuse
- Patient's denial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fresh gas flow of 5 L/minA fresh gas flow of 5 L/min is used during emergence from general anesthesia. | Procedure or surgery | Group Five |
| Fresh gas flow of 10 L/minA fresh gas flow of 10 L/min is used during emergence from general anesthesia. | Procedure or surgery | Group Ten |
Primary outcome
Emergence time
Time frame: From end of surgery to extubation (assessed up to 30 minutes after surgery)
When consciousness and self respiration are fully recovered after surgery is ended, extubation is tried. The time to extubation (emergence time) is recorded.
2 secondary outcomes
Time to spontaneous movement
Time frame: From end of surgery to spontaneous movement (assessed up to 30 minutes after surgery)
Time to eye opening
Time frame: From end of surgery to eye opening (assessed up to 30 minutes after surgery)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2022.
- Background: PubMed 33810063Gaya 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.
- Background: PubMed 28585095Brioni 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.
- Background: PubMed 14530937Baum 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.
- Background: PubMed 17312214Sakata 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.
- Background: PubMed 22321104Difficult 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.
- Derived from this study: PubMed 37478213Park 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Young-Kug Kim, MD, PhD principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fresh gas flow of 5 L/min and Fresh gas flow of 10 L/min in people with Bladder Cancer, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emergence time (time frame: From end of surgery to extubation (assessed up to 30 minutes after surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05376631, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2022.