Sevoflurane Concentrations in Children

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.

Study Overview

• Status: Completed
• Conditions: Sevoflurane; Age; Anesthetic
• Intervention / Treatment: Drug: The washin of sevoflurane in the GE Ohmeda workstation

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 Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14203
      • John R. Oishei Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Children scheduled for ambulatory surgery at Oishei Children's Hospital in Buffalo on both the second and third floors of the hospital

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control is GE Ohmeda workstation; The washin of sevoflurane in the GE Ohmeda workstation during induction of anesthesia.	Drug: The 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; Other Names: The washin of sevoflurane in the Drager Apollo workstation
Intervention is Drager Apollo workstation; The washin of sevoflurane in the Drager Apollo workstation during induction of anesthesia.	Drug: The 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; Other Names: The washin of sevoflurane in the Drager Apollo workstation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From 0 to 10 minutes of induction of anesthesia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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.	within the first 10 minutes of induction of sevoflurane

Collaborators and Investigators

• Sponsor: State University of New York at Buffalo
• Investigators: Principal Investigator: Jerrold Lerman, MD, FRCPC, Great lakes anesthesiology

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2024
• Primary Completion (Actual): October 24, 2024
• Study Completion (Actual): October 24, 2024

Study Registration Dates

• First Submitted: July 15, 2024
• First Submitted That Met QC Criteria: July 15, 2024
• First Posted (Actual): July 19, 2024

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: anesthesia; sevoflurane; children
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Anesthetics; Central Nervous System Depressants; Platelet Aggregation Inhibitors; Anesthetics, General; Anesthetics, Inhalation; Sevoflurane
• Other Study ID Numbers: 00008573

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: I am not interested in sharing the data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No