Ignite Creation Date:
2025-12-24 @ 1:39 PM
Ignite Modification Date:
2025-12-29 @ 1:36 AM
Study NCT ID:
NCT07295795
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-24
First Post:
2025-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Blood Sampling Pre- and Post-Propofol Administration to Characterize the Blood Proteome Using Different Research Assays
Sponsor:
National Institutes of Health Clinical Center (CC)
Organization:
Study Overview
Official Title:
Blood Sampling Pre- and Post-Propofol to Characterize the Blood Proteome Using Different Research Assays
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12-18
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed 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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 002371-CC | None | None | View |