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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05644340
Other study ID # 2019/154
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 16, 2022
Est. completion date April 10, 2023

Study information

Verified date April 2023
Source Istanbul University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Low flow anesthesia was considered to be causing rebreathing, hypoxia and hypercarbia in the past. However, developing technologies made anesthesia ventilators safer. Low flow anesthesia is proved to be safe and cost-effective for almost a decade, and newer anesthetic machines with automated gas flow and metabolic flow anesthesia (<0.3 L/min gas flow) features are now becoming prominent. The literature still lacks of pediatric data regarding the cost analysis and safety profile of low flow and especially in metabolic flow anesthesia. In this study, it is aimed to observe inhaled agent expenditure of automated gas flow anesthesia which reaches metabolic flow limits in pediatric patients. For that, automated gas flow will be set to provide a desired end-tidal sevoflurane concentration during general anesthesia. Accordingly, inspired fraction of oxygen and air values will be recorded in 15-minute intervals. Primary outcome will be the inhaled agent (sevoflurane) amount wasted in milliliters for both inhaled agent maintenance speed (8-fast and 4-slow). Secondarily, delta value of set and detected inspired fraction of oxygen (DeltaFiO2=DetectedFiO2-SetFiO2) will be analyzed. DeltaFiO2 higher than 5 units will be accepted as "unsafe" gas mixture, and the incidence will be evaluated. Secondary outcomes will also include duration of emergence from anesthesia including both extubation and obeying verbal commands.


Recruitment information / eligibility

Status Completed
Enrollment 130
Est. completion date April 10, 2023
Est. primary completion date April 10, 2023
Accepts healthy volunteers No
Gender All
Age group N/A to 18 Years
Eligibility Inclusion Criteria: - Pediatric surgery patients - Elective or Semielective surgeries - Patients suitable for inhalation anesthesia Exclusion Criteria: - Emergency surgery - Patients who are contraindicated for inhalation anesthesia

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Speed 8 (Fast balancing gas flow)
General anesthesia will be induced via intravenous agents, and anesthesia maintenance will be provided via inhalation for all the patients. The maintenance will be provided with sevoflurane using automated gas flow with the selected speed of 8. The anesthesia machine indicates amount of sevoflurane inhaled, inspired and exhaled oxygen, carbon dioxyde, air and sevoflurane concentrations. Accordingly these data and actual flow rate will be recorded every 15 minutes.
Speed 4 (Medium speed balancing gas flow)
General anesthesia will be induced via intravenous agents, and anesthesia maintenance will be provided via inhalation for all the patients. The maintenance will be provided with sevoflurane using automated gas flow with the selected speed of 4 (Medium speed). The anesthesia machine indicates amount of sevoflurane inhaled, inspired and exhaled oxygen, carbon dioxyde, air and sevoflurane concentrations. Accordingly these data and actual flow rate will be recorded every 15 minutes.

Locations

Country Name City State
Turkey Istanbul University Istanbul Faculty of Medicine Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Total amount of sevoflurane consumed At the end of the surgery, total amount of sevoflurane, which is indicated on the anesthesia machine screen, will be recorded in milliliters up to 3 hours
Secondary Time to extubation after inhalation anesthesia stop Time between the inhalation anesthesia stop and extubation in minutes Up to 45 minutes
Secondary Time to cooperation after inhalation anesthesia stop Time between the inhalation anesthesia stop and cooperation to verbal impulses in minutes Up to 2 hours
Secondary Delta Oxygen Concentration The adjusted oxygen fraction (generally 40%) minus the actual inhaled oxygen fraction will provide the delta value. The data will be recorded every 15-minute during the surgery, and delta >%5 will be considered as "unsafe" up to 2 hours
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