AnestheticNCT06510803
Sevoflurane Concentrations in Children
An observational study of Anesthetic and Sevoflurane, run by State University of New York at Buffalo at 1 site in United States.
Trial summary
The sevoflurane concentrations (as well as vital signs, child's date of birth, type of surgery) will be recorded during the first 10 minutes of anesthesia. Read more about this study
- Who is it for?
- Ages 2 to 7 years
- Conditions the study is for
- Anesthetic, Sevoflurane, Age
- What is being tested?
- The washin of sevoflurane in the GE Ohmeda workstation
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2024to 24 Oct 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 2 to 7 years
- All sexes
- No healthy volunteers
- Child
Study population: Children scheduled for ambulatory surgery at Oishei Children's Hospital in Buffalo on both the second and third floors of the hospital
Who may be able to join
- scheduled for elective surgery under general anesthesia,
- American Society of Anesthesiologists physical status 1 or 2 fasted, unpremeditated
Who cannot join
- parents refuse consent
- presence of moderate or severe cardiorespiratory disease
- difficult airway
- malignant hyperthermia
- neuromuscular disorders
- obesity
- obstructive sleep apnea
Trial locations and contacts
1 site in 1 country.
United States1 site
John R. Oishei Children's Hospital
Buffalo, New York, 14203
About this study
Official title: Sevoflurane Concentrations During Induction of Anesthesia With the Drager Apollo and General Electric (GE) Ohmeda Workstations in Children
The sevoflurane concentrations (as well as vital signs, child's date of birth, type of surgery) will be recorded during the first 10 minutes of anesthesia.
Read the detailed description
Protocol definition:
This study will not deviate from standard anesthetic management of children with the exception of recording the child's vital signs and anesthetic gas concentrations during the anesthetic induction.
Healthy children, 2-6 years of age, fasting and unmedicated scheduled to undergo minor elective surgery under general anesthesia at Oishei Children's Hospital in Buffalo, New York will be consented for this protocol by the principal investigator. Parents who speak English will be approached for consent; the formal hospital translator service will be used for those parents who do not speak English. The medical translator will translate the consent form for the parents.
Children will be selected for inclusion in this study from the elective surgery list. A total of 28 children of both sexes will be enrolled, 14 with each of the two workstations. We will strive to include the workstation in each operating room at least once in the study. The choice of anesthesia workstations, Drager Apollo or General Electric (GE) Ohmeda, is predetermined by the floor on which the surgery is planned. Drager Apollo workstations are deployed in each of the 7 pediatric operating rooms on the second floor at Oishei and GE Ohmeda workstations are deployed in each of the 5 pediatric operating rooms on the third floor at Oishei.
Once the standard anesthesia monitors are applied, the children will undergo a routine inhalational induction that begins with a mixture of 5 liters/minute nitrous oxide and 2 liters/minute oxygen. Once the end-tidal nitrous oxide concentration reaches 0.45, the sevoflurane vaporizer will be dialed to 8%. The inspired and expired concentrations of sevoflurane will be recorded at the designated times (see data collection sheet) for the first 10 minutes of anesthesia. All vital signs (oxygen saturation, end-tidal carbon dioxide tension, blood pressure and heart rate) will also be recorded.All unusual movements and airway responses will also be recorded and when they occurred (under Notes on the data collection form). At the conclusion of the 10 minutes of the induction, the airway will be secured with an airway device, the surgery will proceed as planned and the recording will cease. The study will be terminated.
The inspired and expired concentrations of Sevoflurane with the Drager Apollo and GE Ohmeda workstations over time will be summarized and displayed graphically. The maximum inspired concentrations of Sevoflurane during each induction with the two types of workstations will be compared using Student's t-test at a significance level of P\<0.05.
Jerrold Lerman MD, FRCPC, FANZCA (Fellow of the Australian and New Zealand College of Anesthetists) July 11, 2024
- Conditions
- Anesthetic, Sevoflurane, Age
- Being tested
- The washin of sevoflurane in the GE Ohmeda workstation
- Keywords
- sevoflurane, anesthesia, children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The washin of sevoflurane in the GE Ohmeda workstationDrug
Also called The washin of sevoflurane in the Drager Apollo workstation
The increases in the end-tidal to inspired sevoflurane concentrations during induction of anesthesia with the Drager Apollo compared with the GE Ohmeda workstations
| Study group | Role | What they receive |
|---|---|---|
| Control is GE Ohmeda workstation | The washin of sevoflurane in the GE Ohmeda workstation during induction of anesthesia. Receives: Drug: The washin of sevoflurane in the GE Ohmeda workstation | |
| Intervention is Drager Apollo workstation | The washin of sevoflurane in the Drager Apollo workstation during induction of anesthesia. Receives: Drug: The washin of sevoflurane in the GE Ohmeda workstation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratios of the Inspired to Expired Sevoflurane Concentrations During Induction of Anesthesia
We will measure the inspired and expired sevoflurane concentrations using an agent monitor, determine the ratio for each patient during each measurement at 30 seconds for the first 5 minutes of induction and and then every minute until the IV is secured. Data are reported as means and standard deviations at each of the time points and represented in a figure.
Measured: From 0 to 10 minutes of induction of anesthesia
Secondary outcomes (3)
Maximum Inspired Concentration at 1 Minute of Induction
The maximum percent sevoflurane measured at 1 minute of induction of anesthesia will be summarized as means and standard deviation for each workstation.
Measured: At 1 minute during induction of anesthesia
Maximum Sevoflurane Concentrations During Induction of Anesthesia
The maximum sevoflurane concentrations (inspired and expired) during the first 10 minutes of induction of anesthesia
Measured: 10 minutes of induction of anesthesia
Time to Reach 90% of the Maximum Inspired Concentration
The time (minutes) to reach 90% of the maximum inspired sevoflurane concentration during induction of anesthesia.
Measured: within the first 10 minutes of induction of sevoflurane
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start18 Sep 2024
- Primary completion24 Oct 2024
- Study completion24 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnestheticStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jerrold Lerman, State University of New York at Buffalo
- Investigators
- Jerrold Lerman, MD, FRCPC, Principal investigator, Great lakes anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06510803
- Sponsor's protocol ID
- 00008573
- Status last verified
- Feb 2026
- First submitted
- 15 Jul 2024
- Last updated
- 13 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: I am not interested in sharing the data.
Publications
Lerman J, Correa AMR. Sevoflurane Washin With the Drager Apollo and GE Datex Ohmeda Aisys Workstations in Healthy Children. Paediatr Anaesth. 2025 Jul;35(7):535-541. doi: 10.1111/pan.15106. Epub 2025 Apr 3.
PubMed 40178391
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sevoflurane Concentrations During Induction of Anesthesia With the Drager Apollo and General Electric (GE) Ohmeda Workstations in Children
- ClinicalTrials.gov ID
- NCT06510803
- Acronym / sponsor ID
- 00008573
- Conditions
- Anesthetic, Sevoflurane, Age
- Keywords
- sevoflurane, anesthesia, children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 18 Sep 2024 (actual)
- Primary completion
- 24 Oct 2024 (actual)
- Study completion
- 24 Oct 2024 (actual)
- First posted
- 19 Jul 2024 (actual)
- Results
- Posted 13 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The sevoflurane concentrations (as well as vital signs, child's date of birth, type of surgery) will be recorded during the first 10 minutes of anesthesia.
Detailed description
Protocol definition:
This study will not deviate from standard anesthetic management of children with the exception of recording the child's vital signs and anesthetic gas concentrations during the anesthetic induction.
Healthy children, 2-6 years of age, fasting and unmedicated scheduled to undergo minor elective surgery under general anesthesia at Oishei Children's Hospital in Buffalo, New York will be consented for this protocol by the principal investigator. Parents who speak English will be approached for consent; the formal hospital translator service will be used for those parents who do not speak English. The medical translator will translate the consent form for the parents.
Children will be selected for inclusion in this study from the elective surgery list. A total of 28 children of both sexes will be enrolled, 14 with each of the two workstations. We will strive to include the workstation in each operating room at least once in the study. The choice of anesthesia workstations, Drager Apollo or General Electric (GE) Ohmeda, is predetermined by the floor on which the surgery is planned. Drager Apollo workstations are deployed in each of the 7 pediatric operating rooms on the second floor at Oishei and GE Ohmeda workstations are deployed in each of the 5 pediatric operating rooms on the third floor at Oishei.
Once the standard anesthesia monitors are applied, the children will undergo a routine inhalational induction that begins with a mixture of 5 liters/minute nitrous oxide and 2 liters/minute oxygen. Once the end-tidal nitrous oxide concentration reaches 0.45, the sevoflurane vaporizer will be dialed to 8%. The inspired and expired concentrations of sevoflurane will be recorded at the designated times (see data collection sheet) for the first 10 minutes of anesthesia. All vital signs (oxygen saturation, end-tidal carbon dioxide tension, blood pressure and heart rate) will also be recorded.All unusual movements and airway responses will also be recorded and when they occurred (under Notes on the data collection form). At the conclusion of the 10 minutes of the induction, the airway will be secured with an airway device, the surgery will proceed as planned and the recording will cease. The study will be terminated.
The inspired and expired concentrations of Sevoflurane with the Drager Apollo and GE Ohmeda workstations over time will be summarized and displayed graphically. The maximum inspired concentrations of Sevoflurane during each induction with the two types of workstations will be compared using Student's t-test at a significance level of P\<0.05.
Jerrold Lerman MD, FRCPC, FANZCA (Fellow of the Australian and New Zealand College of Anesthetists) July 11, 2024
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control is GE Ohmeda workstation | – | Drug: The washin of sevoflurane in the GE Ohmeda workstationThe washin of sevoflurane in the GE Ohmeda workstation during induction of anesthesia. |
| Intervention is Drager Apollo workstation | – | Drug: The washin of sevoflurane in the GE Ohmeda workstationThe washin of sevoflurane in the Drager Apollo workstation during induction of anesthesia. |
Who may qualify
- Ages
- 2 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children scheduled for ambulatory surgery at Oishei Children's Hospital in Buffalo on both the second and third floors of the hospital
Key inclusion criteria (2 listed)
- scheduled for elective surgery under general anesthesia,
- American Society of Anesthesiologists physical status 1 or 2 fasted, unpremeditated
Key exclusion criteria (7 listed)
- parents refuse consent
- presence of moderate or severe cardiorespiratory disease
- difficult airway
- malignant hyperthermia
- neuromuscular disorders
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 |
|---|---|---|
| The washin of sevoflurane in the GE Ohmeda workstationAlso: The washin of sevoflurane in the Drager Apollo workstationThe increases in the end-tidal to inspired sevoflurane concentrations during induction of anesthesia with the Drager Apollo compared with the GE Ohmeda workstations | Drug | Control is GE Ohmeda workstation, Intervention is Drager Apollo workstation |
Primary outcome
Ratios of the Inspired to Expired Sevoflurane Concentrations During Induction of Anesthesia
Time frame: From 0 to 10 minutes of induction of anesthesia
We will measure the inspired and expired sevoflurane concentrations using an agent monitor, determine the ratio for each patient during each measurement at 30 seconds for the first 5 minutes of induction and and then every minute until the IV is secured. Data are reported as means and standard deviations at each of the time points and represented in a figure.
3 secondary outcomes
Maximum Inspired Concentration at 1 Minute of Induction
Time frame: At 1 minute during induction of anesthesia
Maximum Sevoflurane Concentrations During Induction of Anesthesia
Time frame: 10 minutes of induction of anesthesia
Time to Reach 90% of the Maximum Inspired Concentration
Time frame: within the first 10 minutes of induction of sevoflurane
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40178391Lerman J, Correa AMR. Sevoflurane Washin With the Drager Apollo and GE Datex Ohmeda Aisys Workstations in Healthy Children. Paediatr Anaesth. 2025 Jul;35(7):535-541. doi: 10.1111/pan.15106. Epub 2025 Apr 3.
- Individual participant dataSharing planned: No. I am not interested in sharing the data.
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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.
Jerrold Lerman, MD, FRCPC principal investigator
Great lakes anesthesiology
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 Anesthetic and Sevoflurane, run by State University of New York at Buffalo at 1 site in United States.
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 7 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 13 Feb 2026. 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 United States. 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?
Yes. Results are posted in the registry (first posted 13 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Ratios of the Inspired to Expired Sevoflurane Concentrations During Induction of Anesthesia (time frame: From 0 to 10 minutes of induction of anesthesia). 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 NCT06510803, 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 13 Feb 2026.