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Completed

NCT Number: NCT06510803

Sevoflurane Concentrations 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.

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Key information

Age range

2 year–7 year

Sex eligibility

All sexes

Study type

Observational

Primary location

John R. Oishei Children's Hospital

Buffalo, New York, 14203, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The washin of sevoflurane in the GE Ohmeda workstation

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Maximum Inspired Concentration at 1 Minute of Induction

    Time frame: 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.

  2. Maximum Sevoflurane Concentrations During Induction of Anesthesia

    Time frame: 10 minutes of induction of anesthesia

    The maximum sevoflurane concentrations (inspired and expired) during the first 10 minutes of induction of anesthesia

  3. Time to Reach 90% of the Maximum Inspired Concentration

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

State University of New York at Buffalo

Other

Registry information

Official study title

Sevoflurane Concentrations During Induction of Anesthesia With the Drager Apollo and General Electric (GE) Ohmeda Workstations in Children

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 19, 2024
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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