AnesthesiaNCT04743193
Different Low-flow Sevoflurane Anesthesia Techniques
An observational study of Anesthesia, run by Kocaeli Derince Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
After reaching 1 MAC level with 4 lt / min fresh gas flow and 2.5% sevoflurane concentration in the initial stage in 35 patients, anesthesia maintenance will be continued with 0.5 lt / min fresh gas flow and 2 -4% sevoflurane concentration with the target of 1 MAC. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- 2.5 %sevoflurane and 8% sevoflurane low flow anesthesia
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Feb 2021to 15 May 2021
- How long will I take part?
- 1 Day
- 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 65 years
- All sexes
- Adult, Older adult
Study population: * Patients between the ages of 18-65 * ASA1,2,3 group patients
Who may be able to join
- Patients between the ages of 18-65
- ASA1,2,3 group patients
- Patients under general anesthesia
- Patients scheduled for elective surgery
Who cannot join
- The patient's refusal to participate in the study
- Patients with less than 90 minutes of total anesthesia time
- Patients whose total anesthesia time exceeds 180 minutes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Consumption of Sevoflurane in Two Different Concentrations and Two Different Currents During the Initial Period of Anesthesia in Patients Undergoing General Anesthesia With Minimal Flow
After reaching 1 MAC level with 4 lt / min fresh gas flow and 2.5% sevoflurane concentration in the initial stage in 35 patients, anesthesia maintenance will be continued with 0.5 lt / min fresh gas flow and 2 -4% sevoflurane concentration with the target of 1 MAC. For 35 patients, after reaching 1 (MAC) level with 1 lt / min fresh gas flow and 8% sevoflurane concentration in the initial phase, maintenance of anesthesia will be continued with 0.5 lt / min fresh gas flow and 2 -4% sevoflurane concentration, targeting 1 MAC.
Read the detailed description
The primary aim of this study is to compare the instantaneous and total consumption of sevoflurane using 2 different concentrations and different minute / fresh gas flow to fill the system in the initial phase of anesthesia. Its secondary purpose is to compare the depth of anesthesia and hemodynamic parameters between the two groups.
A total of 70 patients between the ages of 18-65 will be included in the study.in 2.5 % sevoflurane grup After reaching 1 MAC level with 4 lt / min fresh gas flow and 2.5% sevoflurane concentration in the initial stage in 35 patients, anesthesia maintenance will be continued with 0.5 lt / min fresh gas flow and 2 -4% sevoflurane concentration with the target of 1 MAC. in sevoflurane 8 % group for 35 patients, after reaching 1 (MAC) level with 1 lt / min fresh gas flow and 8% sevoflurane concentration in the initial phase, maintenance of anesthesia will be continued with 0.5 lt / min fresh gas flow and 2 -4% sevoflurane concentration with the target of 1 MAC. . The depth of anesthesia for both groups will be measured by the Bispectral Index (BIS). BIS values between 40 and 60 are appropriate values for general anesthesia, for this value 1 MAC sevoflurane inhalation anesthesia and remifentanil infusion (0.1-0.3mcg / kg / min) will be used.
- Conditions
- Anesthesia
- Being tested
- 2.5 %sevoflurane, 8% sevoflurane low flow anesthesia
- Keywords
- inhalation
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2.5 %sevofluraneOther
for 35 patients after reaching 1 MAK level with 4 lt / min fresh gas flow and 2,5% sevoflurane concentration in the initial phase, maintenance of anesthesia will be continued with 0.5 lt / min fresh gas flow and 2 -4% sevoflurane concentration with the target of 1 minimum alveolar concentration
8% sevoflurane low flow anesthesiaOther
For 35 patients after reaching 1 (MAC) level with 1 lt / min fresh gas flow and 8% sevoflurane concentration in the initial phase, maintenance of anesthesia will be continued with 0.5 lt / min fresh gas flow and 2 -4% sevoflurane concentration, targeting 1 MAC. .
| Study group | Role | What they receive |
|---|---|---|
| sevoflurane 8 % | In the initial phase, after reaching 1 (MAK) level with 1lt / min fresh gas flow and 8% sevoflurane concentration, anesthesia maintenance will be continued with 0.5 lt / min fresh gas flow and 2 -4% sevoflurane concentration with the target of 1 MAC. Receives: Other: 8% sevoflurane low flow anesthesia | |
| sevoflurane 2.5 % | In the initial phase, after reaching 1 MAK level with 4 lt / min fresh gas flow and 2.5% sevoflurane concentration, anesthesia maintenance will be continued with 0.5 lt / min fresh gas flow and 2 -4% sevoflurane concentration with the target of 1 MAC. Receives: Other: 2.5 %sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
sevoflurane versus desflurane
To compare the instant and total consumption of sevoflurane using 2 different concentrations and different minute / fresh gas flow to fill the system in the initial phase of anesthesia.
Measured: the study will comlete in one month
Secondary outcomes (1)
sevoflurane
Its secondary purpose is to compare the depth of anesthesia and hemodynamic parameters between the two groups.
Measured: studdy will complete in one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start5 Feb 2021
- Primary completion28 Apr 2021
- Study completion15 May 2021
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
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Kocaeli Derince Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tahsin Şimşek, Kocaeli Derince Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04743193
- Sponsor's protocol ID
- 2020-514-169-13
- Status last verified
- Aug 2021
- First submitted
- 2 Feb 2021
- Last updated
- 1 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Consumption of Sevoflurane in Two Different Concentrations and Two Different Currents During the Initial Period of Anesthesia in Patients Undergoing General Anesthesia With Minimal Flow
- ClinicalTrials.gov ID
- NCT04743193
- Acronym / sponsor ID
- 2020-514-169-13
- Conditions
- Anesthesia
- Keywords
- inhalation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kocaeli Derince Education and Research HospitalUniversity, hospital or other
- Study start
- 5 Feb 2021 (actual)
- Primary completion
- 28 Apr 2021 (actual)
- Study completion
- 15 May 2021 (actual)
- First posted
- 8 Feb 2021 (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.
After reaching 1 MAC level with 4 lt / min fresh gas flow and 2.5% sevoflurane concentration in the initial stage in 35 patients, anesthesia maintenance will be continued with 0.5 lt / min fresh gas flow and 2 -4% sevoflurane concentration with the target of 1 MAC. For 35 patients, after reaching 1 (MAC) level with 1 lt / min fresh gas flow and 8% sevoflurane concentration in the initial phase, maintenance of anesthesia will be continued with 0.5 lt / min fresh gas flow and 2 -4% sevoflurane concentration, targeting 1 MAC.
Detailed description
The primary aim of this study is to compare the instantaneous and total consumption of sevoflurane using 2 different concentrations and different minute / fresh gas flow to fill the system in the initial phase of anesthesia. Its secondary purpose is to compare the depth of anesthesia and hemodynamic parameters between the two groups.
A total of 70 patients between the ages of 18-65 will be included in the study.in 2.5 % sevoflurane grup After reaching 1 MAC level with 4 lt / min fresh gas flow and 2.5% sevoflurane concentration in the initial stage in 35 patients, anesthesia maintenance will be continued with 0.5 lt / min fresh gas flow and 2 -4% sevoflurane concentration with the target of 1 MAC. in sevoflurane 8 % group for 35 patients, after reaching 1 (MAC) level with 1 lt / min fresh gas flow and 8% sevoflurane concentration in the initial phase, maintenance of anesthesia will be continued with 0.5 lt / min fresh gas flow and 2 -4% sevoflurane concentration with the target of 1 MAC. . The depth of anesthesia for both groups will be measured by the Bispectral Index (BIS). BIS values between 40 and 60 are appropriate values for general anesthesia, for this value 1 MAC sevoflurane inhalation anesthesia and remifentanil infusion (0.1-0.3mcg / kg / min) will be used.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sevoflurane 8 % | – | Other: 8% sevoflurane low flow anesthesiaIn the initial phase, after reaching 1 (MAK) level with 1lt / min fresh gas flow and 8% sevoflurane concentration, anesthesia maintenance will be continued with 0.5 lt / min fresh gas flow and 2 -4% sevoflurane concentration with the target of 1 MAC. |
| sevoflurane 2.5 % | – | Other: 2.5 %sevofluraneIn the initial phase, after reaching 1 MAK level with 4 lt / min fresh gas flow and 2.5% sevoflurane concentration, anesthesia maintenance will be continued with 0.5 lt / min fresh gas flow and 2 -4% sevoflurane concentration with the target of 1 MAC. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- * Patients between the ages of 18-65 * ASA1,2,3 group patients
Key inclusion criteria (4 listed)
- Patients between the ages of 18-65
- ASA1,2,3 group patients
- Patients under general anesthesia
- Patients scheduled for elective surgery
Key exclusion criteria (3 listed)
- The patient's refusal to participate in the study
- Patients with less than 90 minutes of total anesthesia time
- Patients whose total anesthesia time exceeds 180 minutes
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 |
|---|---|---|
| 2.5 %sevofluranefor 35 patients after reaching 1 MAK level with 4 lt / min fresh gas flow and 2,5% sevoflurane concentration in the initial phase, maintenance of anesthesia will be continued with 0.5 lt / min fresh gas flow and 2 -4% sevoflurane concentration with the target of 1 minimum alveolar concentration | Other | sevoflurane 2.5 % |
| 8% sevoflurane low flow anesthesiaFor 35 patients after reaching 1 (MAC) level with 1 lt / min fresh gas flow and 8% sevoflurane concentration in the initial phase, maintenance of anesthesia will be continued with 0.5 lt / min fresh gas flow and 2 -4% sevoflurane concentration, targeting 1 MAC. . | Other | sevoflurane 8 % |
Primary outcome
sevoflurane versus desflurane
Time frame: the study will comlete in one month
To compare the instant and total consumption of sevoflurane using 2 different concentrations and different minute / fresh gas flow to fill the system in the initial phase of anesthesia.
1 secondary outcome
sevoflurane
Time frame: studdy will complete in one month
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 1 Sep 2021.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Kocaeli Derince Education and Research Hospital at 1 site in Turkey (Türkiye).
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 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 1 Sep 2021. 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 Turkey (Türkiye). 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?
sevoflurane versus desflurane (time frame: the study will comlete in one month). 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 1 Sep 2021.