臨床研究等提出・公開システム

Japanese

Date of registration	Oct. 16, 2023
Last modified on	Oct. 16, 2023
Trial ID	jRCT1032230398

Scientific Title	Influence of mechanical ventilation settings on breath-by-breath exhaled propofol concentration during general anesthesia: a pharmacokinetic study
Public Title	Is exhaled propofol concentration influenced by mechanical ventilation settings?

Contact for Scientific Queries	Name	Masui Kenichi
	Affiliation	Yokohama City University Hospital
	Address	3-9 Fukuura, Kanazawa-ku, Yokohama Cty, Kanagawa, Japan
	Telephone	+81-45-787-2918
	E-mail	masui.ken.kg@yokohama-cu.ac.jp
Contact for Public Queries	Name	Tsuchiya Tomonori
	Affiliation	Yokohama City University Hospital
	Address	3-9 Fukuura, Kanazawa-ku, Yokohama Cty, Kanagawa, Japan
	Telephone	+81-45-787-2918
	E-mail	yiu41707@yokohama-cu.ac.jp

Recruitment status	Pending

Anticipated date of first enrollment		Oct. 16, 2023
Target sample size		30
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	1) 30 scheduled surgery patients aged 18 and over who are hospitalized at Yokohama City University Hospital (10 aged 18-49, 10 aged 50-69, 10 aged 70 and over. 5 males and 5 females in each age group) 2) Patients who are expected to undergo general anesthesia for more than 3 hours 3) Supine position, general anesthesia patient under double lung ventilation 4) Patients undergoing invasive arterial pressure catheter insertion 5) Patients who have given their written consent to participate in this study
	Exclusion Criteria	1) Patients contraindicated for administration of propofol 2) Patients whose ASA classification, which is the general condition classification of the American Society of Anesthesiologists, is class 4 or higher 3) Surgery with head low or high at 25 degrees or more 4) Patients with interstitial pneumonia, COPD, pulmonary edema, severe cardiac dysfunction, severe liver dysfunction 5) Pregnant women (lactating women)
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Elective surgical procedure
Intervention(s)		1. Selection of anesthesia method (total intravenous anesthesia with propofol) 2. Mechanical ventilator settings during surgery
Intervention(s) Keyword		Anesthesia, Intravenous
Health Condition(s) Code		E04.249
Intervention(s) Code		E03.155.308
Primary Outcome(s)		Prediction Error (PEex) calculated using estimated end tidal expiratory propofol concentration and measured plasma propofol. PEex is defined as (measured plasma propofol concentration - end tidal propofol concentration)/end tidal propofol concentration or measured plasma propofol concentration/end tidal propofol concentration.
Secondary Outcome(s)		The PEex derivatives, pharmacokinetic indices median prediction error (MDPE) and median absolute prediction error (MDAPE), are used to assess the performance of end tidal propofol concentration as a predicted value of plasma propofol concentration. If respiratory conditions influence prediction error, prediction formula will be developed to improve the predictive performance of plasma propofol concentrations using end tidal propofol concentration. The time course of PEex is illustrated. Prediction error of measured plasma propofol concentration vs predicted plasma propofol concentration is calculated as (measured plasma propofol concentration-predicted plasma propofol concentration)/predicted plasma propofol concentration, or as measured plasma propofol concentration/predicted plasma propofol concentration. MDPE and MDAPE are also calculated using predicted plasma concentartion determined using the Marsh model. The time course of the prediction error is dipicted. The end tidal propofol concentration and predicted plasma propofol concentration as predictive values of measured plasma propofol vconcentration are compared.

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Yokohama City University Ethics Committee
Address	3-9 Fukuura, Kanazawa-ku, Yokohama Cty, Kanagawa, Japan, Kanagawa
Telephone	+81-45-787-2800
E-Mail	rinri@yokohama-cu.ac.jp
Approval Status	Approval
Date of approval	July. 14, 2023

Plan to share IPD	Yes
Plan description	The principal investigator or sub-investigator will fill in the necessary information on the case registration form and register it on the computer at the registration center. At this time, a research subject identification code is assigned at the conducting medical institution, but this research subject identification code consists of numbers and symbols that are unrelated to information that can identify a specific individual, such as initials or medical record ID. When creating documents related to this research, such as case registration forms and case report forms, research subject identification codes will be used to prevent individuals from being identified. The research director will use the processed information to create a correspondence table containing information such as the research subject's name and medical record ID so that the research subject can be identified if necessary, and leak it to the outside. Storage management shall be carried out strictly to ensure that no accident occurs. Data provided to joint research institutions, such as research subject case registration forms, case report forms, test data, and samples, must be provided with a research subject identification code or registration number. Data that has been processed so that individuals cannot be identified (limited to data that has been processed or managed so that it cannot be immediately determined which research subject's sample or information belongs to). When providing data to Shoreline Science Research, Inc., it is done by mailing an electromagnetic recording medium such as a USB memory with a password set. Additionally, equipment containing research data that does not include personal information will be transported by vehicle. Blood samples sent to the National Defense Medical College Hospital will be labeled using a research subject identification code and sent within three months of collection at a temperature below -30 degrees by a specialized vendor.

Plan to share IPD

Yes

Plan description

The principal investigator or sub-investigator will fill in the necessary information on the case registration form and register it on the computer at the registration center. At this time, a research subject identification code is assigned at the conducting medical institution, but this research subject identification code consists of numbers and symbols that are unrelated to information that can identify a specific individual, such as initials or medical record ID. When creating documents related to this research, such as case registration forms and case report forms, research subject identification codes will be used to prevent individuals from being identified. The research director will use the processed information to create a correspondence table containing information such as the research subject's name and medical record ID so that the research subject can be identified if necessary, and leak it to the outside. Storage management shall be carried out strictly to ensure that no accident occurs. Data provided to joint research institutions, such as research subject case registration forms, case report forms, test data, and samples, must be provided with a research subject identification code or registration number. Data that has been processed so that individuals cannot be identified (limited to data that has been processed or managed so that it cannot be immediately determined which research subject's sample or information belongs to). When providing data to Shoreline Science Research, Inc., it is done by mailing an electromagnetic recording medium such as a USB memory with a password set. Additionally, equipment containing research data that does not include personal information will be transported by vehicle. Blood samples sent to the National Defense Medical College Hospital will be labeled using a research subject identification code and sent within three months of collection at a temperature below -30 degrees by a specialized vendor.

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	None