Hypotension after induction of general anesthesia: occurrence, risk factors, and therapy. A prospective multicentre observational study.
Ondrej Jor, Jan Maca, Jirina Koutna...
https://pubmed.ncbi.nlm.nih.gov/30027443/Actively Recruiting
Led by Recep Tayyip Erdogan University · Updated on 2025-04-09
660
Participants Needed
5
Research Sites
26 weeks
Total Duration
Researchers are investigating how well certain heart function measurements, called Pressure Recording Analytical Method PRAM parameters, relate to cardiovascular risk factors like hypertension and diabetes in patients undergoing major surgery. The study aims to understand how these measurements can identify patients at risk of low blood pressure after anesthesia induction, which is important for improving patient care during surgery. The research is designed as an observational study and focuses especially on patients with hypertension and other cardiovascular risks undergoing major surgical procedures. Participants will be monitored using advanced hemodynamic devices, including the MostCare system, which measures PRAM parameters. All patients will undergo a passive leg raising test lasting 30 seconds to help assess their cardiovascular status. Hemodynamic data will be collected before, during, and after the test and throughout the surgery, which typically lasts between one and ten hours. The study will include patients with both low and normal cardiac reserve and efficiency as determined by PRAM parameters. During the study, participants will be closely observed with invasive blood pressure monitoring and the MostCare device. Researchers will collect detailed medical histories and measure various cardiac-related parameters from the start of surgery until its completion. They will track occurrences of low blood pressure after anesthesia and examine factors that predict such hypotension. Participation involves major surgery lasting more than two hours and at least two days of postoperative hospital stay. The entire monitoring period may last up to 10 hours, with ongoing evaluations during this time.
CONDITIONS
Pressure Recording Analytical Method Parameters and Their Relationship With Hypotension in Hypertensive Patients
B
Başar Erdivanlı, Assoc. Prof.
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Recep Tayyip Erdogan University
Lead Sponsor
Turkish Society of Thoracic and Cardio-Vascular Anesthesia and Intensive Care
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From the start of surgery until the end of surgery (approximately 60 to 600 minutes)
Participants undergo a passive leg raising test with hemodynamic monitoring using the MostCare device to evaluate cardiac reserve and efficiency during surgery.
1 surgical visit with continuous monitoring during surgery
Duration - Duration of hospital stay after surgery (more than 2 days)
Medical history and relevant cardiovascular risk factors are collected to observe relationships with hemodynamic outcomes.
Postoperative hospital stay with routine assessments
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Lead Sponsor
Turkish Society of Thoracic and Cardio-Vascular Anesthesia and Intensive Care
Collaborating Sponsor