Blood Sampling Pre- and Post-Propofol Administration to Characterize the Blood Proteome Using Different Research Assays

National Institutes of Health Clinical Center (CC)

Status: Begins enrollment this month

Conditions: Critically Ill Surgical Patients

Study type: Observational

Funder types: NIH

Identifiers

NCT07295795

10002371

002371-CC

Details and patient eligibility

About

Background:

Propofol is a drug that helps people fall asleep quickly and stay asleep during surgery, so they do not feel any pain. This drug is also used to sedate critically ill people who must be on a ventilator (a machine to help them breathe). To better understand how to interpret blood tests in these ill people, researchers need to know more about how the drug itself may change proteins in the blood.

Objective:

To collect blood samples from people before and after propofol is administered for surgery.

Eligibility:

People aged 18 years or older who are scheduled for surgery that requires sedation with propofol.

Design:

Participants will have data collected. This data will include age, sex, and ethnicity. They will be asked about their medical history.

Participants will have blood samples collected before and after they receive propofol for their surgery. The blood will be collected from lines already installed for the surgery; no new needlesticks will be done for the study. A total of 3 teaspoons of blood will be drawn.

The samples will be compared to each other to look for any changes caused by the drug.

No follow-up visits are required.

Full description

Study Description:

This is a blood procurement research protocol. The study will collect a total of 3 blood samples at 2 timepoints (1 blood sample prior to propofol and 2 after propofol dosing) from up to 10 participants pre- and post-induction of anesthesia with propofol to characterize the effects of propofol on the measurement of the blood proteome using different research assays. Blood samples will be withdrawn from existing intravenous access so that no additional interventions are required. The PI, or team designee, will have a discussion with the primary surgeon to determine suitability of the potential participant for eligibility. If determined suitable, the participant will be recruited by invitation. All potential participants will be consented to a primary surgical protocol; consent to this protocol will be secondary and obtained prior to the procedure.

Objectives:

Primary Objective:

The primary objective of this research protocol is to procure blood samples from participants prior to and post propofol administration to quantify the impact of propofol on the quantification of the blood proteome.

Endpoints:

The primary endpoint of this study is the reproducibility measurements based on the repeated quantifications of biomarkers using different biomarker assays Pre- and Post-Propofol administration.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Provision of signed and dated informed consent form
2. Participant consented for a surgical procedure (primary surgical protocol) anticipated to require induction with propofol.
3. Male or female aged 18 years or older.
4. Ability of subject to understand and the willingness to sign a written informed consent document.

EXCLUSION CRITERIA:

1. Surgical procedure not utilizing propofol
2. Hemoglobin < 7 ug/dL at the time of enrollment
3. Inability to sign consent

Trial design

10 participants in 1 patient group

Critically ill surgical patients

Description:

Participant consented for a surgical procedure (primary surgical protocol) anticipated to require induction with propofol.