Age, Anesthetic, Sevoflurane
Conditions
Keywords
sevoflurane, anesthesia, children
Brief 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.
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
Interventions
DRUGThe washin of sevoflurane in the GE Ohmeda 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
Sponsors
State University of New York at Buffalo
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Years to 7 Years
Healthy volunteers
No
Inclusion criteria
* scheduled for elective surgery under general anesthesia, * American Society of Anesthesiologists physical status 1 or 2 fasted, unpremeditated
Exclusion criteria
* parents refuse consent * presence of moderate or severe cardiorespiratory disease * difficult airway * malignant hyperthermia * neuromuscular disorders * obesity * obstructive sleep apnea
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ratios of the Inspired to Expired Sevoflurane Concentrations During Induction of Anesthesia | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Inspired Concentration at 1 Minute of Induction | At 1 minute during induction of anesthesia | The maximum percent sevoflurane measured at 1 minute of induction of anesthesia will be summarized as means and standard deviation for each workstation. |
| Maximum Sevoflurane Concentrations During Induction of Anesthesia | 10 minutes of induction of anesthesia | The maximum sevoflurane concentrations (inspired and expired) during the first 10 minutes of induction of anesthesia |
| Time to Reach 90% of the Maximum Inspired Concentration | within the first 10 minutes of induction of sevoflurane | The time (minutes) to reach 90% of the maximum inspired sevoflurane concentration during induction of anesthesia. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJerrold Lerman, MD, FRCPC
Great lakes anesthesiology
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized Age | 3.6 years STANDARD_DEVIATION 1 |
| Race and Ethnicity Not Collected | 0 Participants |
| Ratio of alveolar to inspired sevoflurane concentrations | 0 ratio STANDARD_DEVIATION 0 |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 0 / 12 | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
None listed