Sevoflurane Concentrations in Children

NCT06510803 | Completed Results FDA Drug

• 1 other identifier: 00008573
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthetic; Sevoflurane; Age

Keywords

sevoflurane; anesthesia; children

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Maximum Inspired Concentration at 1 Minute of Induction

  At 1 minute during induction of anesthesia

• Maximum Sevoflurane Concentrations During Induction of Anesthesia

  10 minutes of induction of anesthesia

• Time to Reach 90% of the Maximum Inspired Concentration

  within the first 10 minutes of induction of sevoflurane

Study Arms (2)

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

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

Interventions

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

Also known as: The washin of sevoflurane in the Drager Apollo workstation

Control is GE Ohmeda workstation; Intervention is Drager Apollo workstation

Eligibility Criteria

• Age: 2 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

• scheduled for elective surgery under general anesthesia,
• American Society of Anesthesiologists physical status 1 or 2 fasted, unpremeditated

You may not qualify if:

• parents refuse consent
• presence of moderate or severe cardiorespiratory disease
• difficult airway
• malignant hyperthermia
• neuromuscular disorders
• obesity
• obstructive sleep apnea

Sponsors & Collaborators

• State University of New York at Buffalo: lead

Study Sites (1)

John R. Oishei Children's Hospital

Buffalo, New York, 14203, United States

Location

Results Point of Contact

• Title: Dr. Jerrold Lerman
• Organization: Great Lakes Anesthesiology

jlerman@rogers.com

7163236570

Study Officials

• Jerrold Lerman, MD, FRCPC

  Great lakes anesthesiology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor of Anesthesia

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: July 19, 2024
• Study Start: September 18, 2024
• Primary Completion: October 24, 2024
• Study Completion: October 24, 2024
• Last Updated: February 13, 2026
• Results First Posted: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)