Study on the Effect of Norepinephrine Infusion for Managing Low Blood Pressure in Patients Undergoing Non-Cardiac Surgery

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What is this study about?

This clinical trial is focused on studying the effects of a medication called norepinephrine, also known as noradrenaline, on managing low blood pressure, or hypotension, during surgeries that do not involve the heart. The trial aims to determine if using norepinephrine is better than the usual methods for controlling blood pressure during these types of surgeries.

Participants in the study will receive either an infusion of norepinephrine or standard blood pressure management during their surgery. The study will monitor the occurrence of low blood pressure during and shortly after the surgery. The goal is to see if norepinephrine can help maintain stable blood pressure more effectively than the standard approach.

Throughout the study, researchers will also observe other health outcomes, such as the time spent with low blood pressure during and after surgery, and any major complications related to blood flow, like heart injury, kidney problems, stroke, or infections. The study will also track how many days participants spend alive and at home within 30 days after their surgery. This research will help improve understanding of how to best manage blood pressure during non-heart-related surgeries.

1 joining the study

Participation begins after providing written informed consent. Eligibility includes being 45 years or older, undergoing elective or accelerated non-cardiac surgery expected to last at least one hour, and requiring an overnight hospital stay. The surgery must involve general, neuraxial, or combined anesthesia. The American Society of Anesthesiologists (ASA) physical status class must be II or higher.

2 pre-surgery preparation

Before surgery, preparation involves standard medical assessments to ensure readiness for the procedure. This includes monitoring vital signs and reviewing medical history.

3 administration of medication

During surgery, a solution containing norepinephrine is administered as an infusion. This medication is used to manage blood pressure and prevent perioperative hypotension, which is a drop in blood pressure during and shortly after surgery.

4 monitoring during surgery

Throughout the surgery, blood pressure is closely monitored. The primary focus is to prevent mean arterial pressure (MAP) from dropping to 55 mmHg or lower. This monitoring continues up to four hours after surgery.

5 post-surgery observation

After surgery, observation includes monitoring for any complications related to blood pressure management. This includes checking for major complications such as myocardial injury, acute kidney injury, stroke, cardiac arrest, sepsis, and any infusion-related reactions.

6 follow-up period

The follow-up period extends up to 30 days after surgery. During this time, the focus is on recovery and monitoring days alive and at home. Any complications or issues are addressed as needed.

Who Can Join the Study?

Must be 45 years old or older.
Scheduled for non-cardiac surgery that is planned in advance or needs to be done quickly, expected to last 1 hour or more.
Surgery requires general anesthesia (medicine to make you sleep during surgery), neuraxial anesthesia (medicine injected near the spine), or a combination of both.
Expected to stay in the hospital for at least one night after surgery.
Must provide written informed consent, which means you agree to participate in the study after understanding what it involves.
Must have an American Society of Anesthesiologists (ASA) physical status class II or higher, which means you have mild to severe health issues but are not completely healthy.

Who Cannot Join the Study?

Patients who are not having non-cardiac surgery.
Patients who are not experiencing low blood pressure, also known as hypotension, during surgery.
Patients who are not within the specified age range for the study.
Patients who belong to a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Uniwersyteckie Centrum Kliniczne Im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego W Katowicach	Katowice	Poland

Other Sites

Site Name	City	Country
Wojewodzki Szpital Specjalistyczny W Olsztynie	Olsztyn	Poland
Uniwersytecki Szpital Kliniczny W Opolu	Opole	Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 W Lublinie	Lublin	Poland
Skzlvbootlu Pkljbabuz Srqgxql Kyzdzneiu Nq 1 Idasjxmdcxyenyggez Sxwitdq Soctrbaqh Upuvxiaswwxa Mqlgxarbcs W Kquajtiwpr	Zabrze	Poland
5 Welsaapo Spfuceb Kjpuqaxif Z Plulwsjztpa Sftfguoveki Pnbwwexzr Zvqrhm Ozzqyh Ztzoqggnuj W Kehpcdnk	Cracow	Poland

Trial status

Country	Status	Recruitment Start
Poland	Recruiting	01.07.2024

Trial locations

Investigated drugs:

Norepinephrine

Noradrenaline is a medication used in this study to manage blood pressure during surgery. It is being tested to see if it is more effective than the usual methods for controlling low blood pressure in patients undergoing non-cardiac surgery. Noradrenaline works by narrowing blood vessels, which can help increase blood pressure.

Hypotension in Non-Cardiac Surgery – This condition refers to a drop in blood pressure that occurs during or shortly after non-cardiac surgical procedures. It is characterized by a mean arterial pressure reading of 55 mmHg or lower. This drop in blood pressure can lead to inadequate blood flow to vital organs, potentially causing complications. The condition is often monitored closely during surgery to prevent any adverse effects. It is not considered a rare disease and is a common concern in surgical settings.

Trial ID:

2023-508255-39-00

Protocol code:

HYP-NOR

Trial Phase:

Therapeutic confirmatory (Phase III)

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