AnesthesiaNCT03510013
1-1-8 Wash-in for Sevoflurane Low Flow Anesthesia
A study testing 1-1-8 wash-in and Sevoflurane in people with Anesthesia, run by Khon Kaen University at 1 site in Thailand.
Trial summary
The investigators propose a new wash-in technique for sevoflurane low flow anesthesia with fresh gas flow of O2:N2O or O2:air 1:1 L/min with sevoflurane 8%. The objective of this study is to identify time to achieve alveolar concentration of sevoflurane at 1, 1.5, 2, 2.5, 3, and 3.5% Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- 1-1-8 wash-in and Sevoflurane
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteThailand
- Study dates
- 1 Apr 2018to 31 May 2018
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA classification I-II
- age 18-65 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
The investigators propose a new wash-in technique for sevoflurane low flow anesthesia with fresh gas flow of O2:N2O or O2:air 1:1 L/min with sevoflurane 8%.
The objective of this study is to identify time to achieve alveolar concentration of sevoflurane at 1, 1.5, 2, 2.5, 3, and 3.5%
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 for sevoflurane are complicated and time consuming. The investigators propose a new 1-1-8 sevoflurane wash-in protocol which is more simple and predictable.
The objective of this study is to identify time to achieve alveolar concentration of sevoflurane at 1, 1.5, 2, 2.5, 3, and 3.5% with 1-1-8 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 or O2:air 1:1 L/min with sevoflurane 8%. Time to achieve alveolar concentration of sevoflurane at 1, 1.5, 2, 2.5, 3, and 3.5% will be recorded and analyzed. After that, the concentration of sevoflurane and anesthetic technique will be adjusted to requirement of anesthesiologist.
- Conditions
- Anesthesia
- Being tested
- 1-1-8 wash-in, Sevoflurane
- Keywords
- low flow anesthesia, wash-in, sevoflurane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1-1-8 wash-inProcedure or surgery
wash-in phase during start of low flow anesthesia
SevofluraneDrug
Also called Inhalation anesthetic
Drug used for wash-in protocol
| Study group | Role | What they receive |
|---|---|---|
| 1-1-8 wash-in | Experimental | Wash-in using O2:N2O or O2:air 1:1 L/min with sevoflurane 8% Receives: Procedure: 1-1-8 wash-in; Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time
Time (in second) to achieve alveolar concentration of sevoflurane 1, 1.5, 2, 2.5, 3, and 3.5%
Measured: participants will be followed until alveolar concentration of sevoflurane reaches 3.5%, as expected of 10 minutes
Secondary outcomes (2)
Heart rate
Heart rate (beat/min) at alveolar concentration of sevoflurane of 1, 1.5, 2, 2.5, 3 and 3.5%
Measured: participants will be followed until alveolar concentration of sevoflurane reaches 3.5%, as expected of 10 minutes]
Blood pressure
Blood pressure (systolic and diastolic (mmHg)) at alveolar concentration of sevoflurane of 1, 1.5, 2, 2.5, 3 and 3.5%
Measured: participants will be followed until alveolar concentration of sevoflurane reaches 3.5%, as expected of 10 minutes]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2018
- Study start1 Apr 2018
- Primary completion31 May 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will receive sevoflurane 8% with O2:N2O or O2:air 1:1 L/min under controlled ventilation. Time to achieve alveolar concentration of sevoflurane of 1%, 1.5%, 2%, 2.5%, 3% and 3.5% will be recorded.
- Masking
- None (open label)
- Enrolment
- 100 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
- NCT03510013
- Sponsor's protocol ID
- HE601228
- Status last verified
- Aug 2018
- First submitted
- 17 Apr 2018
- Last updated
- 8 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tribuddharat S, Sathitkarnmanee T, Vattanasiriporn N, Thananun M, Nonlhaopol D, Somdee W. 1-1-8 one-step sevoflurane wash-in scheme for low-flow anesthesia: simple, rapid, and predictable induction. BMC Anesthesiol. 2020 Jan 24;20(1):23. doi: 10.1186/s12871-020-0940-2.
PubMed 31980020
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 1-1-8 Wash-in for Sevoflurane Low Flow Anesthesia
- ClinicalTrials.gov ID
- NCT03510013
- Acronym / sponsor ID
- HE601228
- Conditions
- Anesthesia
- Keywords
- low flow anesthesia, wash-in, sevoflurane
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 27 Apr 2018 (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 investigators propose a new wash-in technique for sevoflurane low flow anesthesia with fresh gas flow of O2:N2O or O2:air 1:1 L/min with sevoflurane 8%.
The objective of this study is to identify time to achieve alveolar concentration of sevoflurane at 1, 1.5, 2, 2.5, 3, and 3.5%
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 for sevoflurane are complicated and time consuming. The investigators propose a new 1-1-8 sevoflurane wash-in protocol which is more simple and predictable.
The objective of this study is to identify time to achieve alveolar concentration of sevoflurane at 1, 1.5, 2, 2.5, 3, and 3.5% with 1-1-8 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 or O2:air 1:1 L/min with sevoflurane 8%. Time to achieve alveolar concentration of sevoflurane at 1, 1.5, 2, 2.5, 3, and 3.5% will be recorded and analyzed. After that, the concentration of sevoflurane and anesthetic technique will be adjusted to requirement of anesthesiologist.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will receive sevoflurane 8% with O2:N2O or O2:air 1:1 L/min under controlled ventilation. Time to achieve alveolar concentration of sevoflurane of 1%, 1.5%, 2%, 2.5%, 3% and 3.5% will be recorded.
| Arm | Type | Receives |
|---|---|---|
| 1-1-8 wash-in | Experimental | Procedure: 1-1-8 wash-in, Drug: SevofluraneWash-in using O2:N2O or O2:air 1:1 L/min with sevoflurane 8% |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA classification I-II
- age 18-65 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 |
|---|---|---|
| 1-1-8 wash-inwash-in phase during start of low flow anesthesia | Procedure or surgery | 1-1-8 wash-in |
| SevofluraneAlso: Inhalation anestheticDrug used for wash-in protocol | Drug | 1-1-8 wash-in |
Primary outcome
Time
Time frame: participants will be followed until alveolar concentration of sevoflurane reaches 3.5%, as expected of 10 minutes
Time (in second) to achieve alveolar concentration of sevoflurane 1, 1.5, 2, 2.5, 3, and 3.5%
2 secondary outcomes
Heart rate
Time frame: participants will be followed until alveolar concentration of sevoflurane reaches 3.5%, as expected of 10 minutes]
Blood pressure
Time frame: participants will be followed until alveolar concentration of sevoflurane reaches 3.5%, as expected of 10 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 8 Aug 2018.
- Derived from this study: PubMed 31980020Tribuddharat S, Sathitkarnmanee T, Vattanasiriporn N, Thananun M, Nonlhaopol D, Somdee W. 1-1-8 one-step sevoflurane wash-in scheme for low-flow anesthesia: simple, rapid, and predictable induction. BMC Anesthesiol. 2020 Jan 24;20(1):23. doi: 10.1186/s12871-020-0940-2.
- 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.
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?
A study testing 1-1-8 wash-in and Sevoflurane in people with 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 8 Aug 2018. 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 (time frame: participants will be followed until alveolar concentration of sevoflurane reaches 3.5%, as expected of 10 minutes). 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 NCT03510013, which also lists 1 linked publication.
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 8 Aug 2018.