AnesthesiaNCT02013882
1-1-12 Wash-in for Desflurane Low Flow Anesthesia
An observational study of Anesthesia, run by Khon Kaen University at 1 site in Thailand.
Trial summary
We propose a new wash-in technique for desflurane low flow anesthesia with fresh gas flow of O2:N2O 1:1 L/min with desfluraene 12%. The objective of this study is to identify time to achieve alveolar concentration of desflurane at1, 2, 3, 4, 5 and 6%. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- 1-1-12 wash-in
- Type of treatment
- Surgery or procedure
- How many people
- 106 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2014to Jan 2014
- Phase
- Observational
- 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 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: patients undergoing general anesthesia with endotracheal intubation and controlled ventilation
Who may be able to join
- ASA classification I-II
- age 18-64 years
Who cannot join
- BMI > 35
- contraindicated for N2O
- with pulmonary or cardiac disease
Trial locations and contacts
1 site in 1 country.
About this study
We propose a new wash-in technique for desflurane low flow anesthesia with fresh gas flow of O2:N2O 1:1 L/min with desfluraene 12%.
The objective of this study is to identify time to achieve alveolar concentration of desflurane at1, 2, 3, 4, 5 and 6%.
Read the detailed description
The benefits of low flow anesthesia are economic, less pollution, more heat and humidity preservation but it requires appropriate wash-in phase. The current wash-in protocols are complicated and time consuming. We propose a new 1-1-12 desflurane wash-in protocol which is more simple and predictable.
The objective of this study is to identify time to achieve alveolar concentration of desflurane at 1, 2, 3, 4, 5 and 6% with 1-1-12 wash-in protocol.
All patients will receive iv propofol 2 mg/kg as induction agent and succinyl choline 1.5 mg/kg for intubation. Then the ventilation will be controlled to achieve end-tidal CO2 30-35 mmHg with O2:N2O 1:1 L/min with desflurane 12%. Time to achieve alveolar concentration of desflurane at 1, 2, 3, 4, 5 and 6% will be recorded and analyzed. After that, the concentration of desflurane and anesthetic technique will be adjusted to requirement of anesthesiologist.
- Conditions
- Anesthesia
- Being tested
- 1-1-12 wash-in
- Keywords
- low flow anesthesia, wash-in, desflurane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1-1-12 wash-inProcedure or surgery
wash-in phase during start of low flow anesthesia
| Study group | Role | What they receive |
|---|---|---|
| 1-1-12 wash-in | wash-in using O2:N2O 1:1 L/min with desflurane 12% Receives: Procedure: 1-1-12 wash-in |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time (in second) to achieve alveolar concentration of desflurane 1, 2, 3, 4, 5 and 6%
Measured: participants will be followed until alveolar concentration of desflurane reaches 6%, as expected of 15 minutes
Secondary outcomes (1)
Heart rate
Measured: participants will be followed until alveolar concentration of desflurane reaches 6%, as expected of 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thepakorn Sathitkarnmanee, Khon Kaen University
- Investigators
- Thepakorn Sathitkarnmanee, MD, Principal investigator, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02013882
- Sponsor's protocol ID
- HE561247
- Status last verified
- Feb 2014
- First submitted
- 5 Dec 2013
- Last updated
- 11 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 1-1-12 Wash-in for Desflurane Low Flow Anesthesia
- ClinicalTrials.gov ID
- NCT02013882
- Acronym / sponsor ID
- HE561247
- Conditions
- Anesthesia
- Keywords
- low flow anesthesia, wash-in, desflurane
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 17 Dec 2013 (estimated)
- 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.
We propose a new wash-in technique for desflurane low flow anesthesia with fresh gas flow of O2:N2O 1:1 L/min with desfluraene 12%.
The objective of this study is to identify time to achieve alveolar concentration of desflurane at1, 2, 3, 4, 5 and 6%.
Detailed description
The benefits of low flow anesthesia are economic, less pollution, more heat and humidity preservation but it requires appropriate wash-in phase. The current wash-in protocols are complicated and time consuming. We propose a new 1-1-12 desflurane wash-in protocol which is more simple and predictable.
The objective of this study is to identify time to achieve alveolar concentration of desflurane at 1, 2, 3, 4, 5 and 6% with 1-1-12 wash-in protocol.
All patients will receive iv propofol 2 mg/kg as induction agent and succinyl choline 1.5 mg/kg for intubation. Then the ventilation will be controlled to achieve end-tidal CO2 30-35 mmHg with O2:N2O 1:1 L/min with desflurane 12%. Time to achieve alveolar concentration of desflurane at 1, 2, 3, 4, 5 and 6% will be recorded and analyzed. After that, the concentration of desflurane and anesthetic technique will be adjusted to requirement of anesthesiologist.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1-1-12 wash-in | – | Procedure: 1-1-12 wash-inwash-in using O2:N2O 1:1 L/min with desflurane 12% |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- patients undergoing general anesthesia with endotracheal intubation and controlled ventilation
Key inclusion criteria (2 listed)
- ASA classification I-II
- age 18-64 years
Key exclusion criteria (3 listed)
- BMI > 35
- contraindicated for N2O
- with pulmonary or cardiac disease
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 |
|---|---|---|
| 1-1-12 wash-inwash-in phase during start of low flow anesthesia | Procedure or surgery | 1-1-12 wash-in |
Primary outcome
Time (in second) to achieve alveolar concentration of desflurane 1, 2, 3, 4, 5 and 6%
Time frame: participants will be followed until alveolar concentration of desflurane reaches 6%, as expected of 15 minutes
1 secondary outcome
Heart rate
Time frame: participants will be followed until alveolar concentration of desflurane reaches 6%, as expected of 15 minutes
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 11 Feb 2014.
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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.
Thepakorn Sathitkarnmanee, MD principal investigator
Khon Kaen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, run by Khon Kaen University at 1 site in Thailand.
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 2 inclusion and 3 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 11 Feb 2014. 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 Thailand. 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?
Time (in second) to achieve alveolar concentration of desflurane 1, 2, 3, 4, 5 and 6% (time frame: participants will be followed until alveolar concentration of desflurane reaches 6%, as expected of 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Feb 2014.