Effect of Fresh Gas Flow on Emergence Time
August 16, 2022 updated by: Young-Kug Kim, MD, Asan Medical Center
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of, 05505
- Asan Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
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.
|
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.
|
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
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.
|
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
Time Frame: From end of surgery to spontaneous movement (assessed up to 30 minutes after surgery)
|
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
Time Frame: From end of surgery to eye opening (assessed up to 30 minutes after surgery)
|
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
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.