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Hypotension clinical trials

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NCT ID: NCT06291714 Not yet recruiting - Acute Kidney Injury Clinical Trials

Non-invasive Measurement of the Hypotension Prediction Index for the Reduction of Intraoperative Hypotension

Clearsight
Start date: August 1, 2024
Phase: N/A
Study type: Interventional

In order to reduce the incidence of IOH, various goal-directed therapy (GDT) protocols have already been introduced with success regarding the reduction of postoperative AKI and MINS. However, these studies used an invasive hemodynamic monitoring which offered a continuous surveillance of the blood pressure. In contrast, standard non-invasive blood pressure monitoring results in a blind gap between two measurements (mostly three or five minutes). In order to address this limitation, different continuous non-invasive blood pressure monitoring devices have been introduced. The next evolutional step of non-invasive cardiac output monitoring was to prevent IOH before their onset by using the Hypotension Prediction Index (HPI). Based on the Edward ́s monitoring platform, HPI is a monitoring tool which aims to predict IOH (defined as MAP<65 mmHg for at least one minute) up to 15 min before its onset. The underlying machine learning based algorithm uses analyses features from the pressure waveform and was first calculated from a large retrospective data set of surgical patients and subsequently validated in a prospective cohort. In this study HPI showed a sensitivity of 88% and specificity of 87% for predicting IOH 15 min before its onset. Since then, own and studies of other working groups confirmed the effective prevention of IOH by the use of HPI-based GDT. Until today the arterial waveform analysis was dependent on invasive arterial measurement but since Edwards Lifesciences already promoted the start of the HPI on the ClearSight platform a non-invasive measurement will soon be possible. Further, until now it has not yet been proven that the perioperative use of a continuous non-invasive blood pressure monitoring has a beneficial effect on the patient´s outcome. Study objectives The aim of the study is to investigate whether a hemodynamic protocol based on continuous non-invasive cardiac output monitoring (ClearSight system) compared to standard care can reduce the incidence of IOH, postoperative AKI, and MINS in patients undergoing major trauma and orthopedic surgery.

NCT ID: NCT06258967 Not yet recruiting - Elderly Clinical Trials

Ciprofol Titrated Induction in Reducing Post-induction Hypotension in Geriatric Patients

CTIH
Start date: February 20, 2024
Phase: N/A
Study type: Interventional

Geriatric patients undergoing general anesthesia face a significant challenge, with the induction phase contributing to 50% of hypotensive events. Titrated anesthesia, involving gradual drug administration, suits elderly induction. However, propofol in titrated anesthesia tends to induce hypotension. In contrast, Ciprofol (HSK3486), a novel anesthetic, reduces hypotension during induction. This study compares hypotension incidences during induction and post-induction phases, agitation rates during recovery, perioperative awareness, postoperative delirium, and parameters in elderly patients induced with Ciprofol versus propofol through titrated anesthesia. The goal is to clarify a medically optimized anesthesia protocol for elderly patients during titrated anesthesia induction in general anesthesia.

NCT ID: NCT06258356 Not yet recruiting - Clinical trials for the Severity and Duration of Intraoperative Hypotension

Remimazolam in High Risk ERCP Patients

Start date: February 15, 2024
Phase: N/A
Study type: Interventional

We conducted a randomized trial to investigate whether the administration of Remimazolam in patients undergoing high-risk endoscopic retrograde cholangiopancreatography (ERCP) could significantly reduce the occurrence of intraoperative hypotension, facilitate rapid induction, and result in fewer associated complications.

NCT ID: NCT06257316 Not yet recruiting - Hypotension Clinical Trials

Appropriate Dosage of Vasopressor in Neonates and Infants

Start date: February 15, 2024
Phase: Phase 4
Study type: Interventional

In this study, the investigators will evaluate cerebral blood flow before and after drug infusion using ultrasound to suggest blood pressure criteria and dosage of ephedrine, a vasopressor, to maintain adequate cerebral blood flow in neonates and infants undergoing surgery and anesthesia.

NCT ID: NCT06248593 Not yet recruiting - Hypotension Clinical Trials

Continuous Infusion of Norepinephrine vs Phenylephrine During Spinal Anesthesia for Cesarean Section (INPEACE)

INPEACE
Start date: February 15, 2024
Phase: Phase 4
Study type: Interventional

The goal of this clinical trial is to compare norepinephrine and ephedrine in maintaining blood pressure during spinal anaesthesia for elective cesarean delivery. The main questions it aims to answer are: - Do phenylephrine and norepinephrine administered as manually controlled continuous infusion during elective cesarean delivery have different effects on neonatal outcome ? - Do phenylephrine and norepinephrine administered as manually controlled continuous infusion during elective cesarean delivery have different effects on maternal hemodynamics? Participants will receive either phenylephrine or norepinephrine infusion, at the time of performing spinal anesthesia, the infusion rate will be adjusted manually depending on maternal arterial pressure.

NCT ID: NCT06247384 Not yet recruiting - Clinical trials for Hypotension During Surgery

The Hypotension Prediction Index in Major Abdominal Surgery

Start date: August 1, 2024
Phase: N/A
Study type: Interventional

The goal of this randomized clinical trial is to compare different types of advanced hemodynamic monitoring in patients undergoing major abdominal surgery. Participants undergoing major abdominal surgery will receive anesthesia with two different types of hemodynamic monitoring - group A will receive arterial pressure cardiac output algorithm with the FloTrac sensor and group B will receive hemodynamic monitoring with the Hypotension Prediction Index. The main question the study aims to answer is: • will the hypotension prediction index algorithm reduce the rate of hypotension in comparison to arterial pressure cardiac output algorithm.

NCT ID: NCT06240234 Not yet recruiting - Clinical trials for Monitoring, Intraoperative

Artificial Intelligence - to Predict and Prevent Hypotension During Surgery

Start date: February 2024
Phase: N/A
Study type: Interventional

The goal of this medtech clinical trial is to develop and evaluate a machine learning algoritm to predict low blood pressure episodes during major surgery. The main questions it aims to answer are: - Could a novel method for cardiac output estimation through alterations in carbon dioxide improve the performance of a blood pressure based algoritm in order to predict low blood pressure episodes during major abdominal surgery? - Will the predictive performance of the algoritm improve with the addition of other patient specific data? - Do the estimated cardiac output and central venous saturation by the novel method agree with our invasive arterial pressure method for cardiac output, and samples via a central venous line, respectively? 300 participants will be anesthetized with total intravenous anesthesia and ventilated with the novel carbon dioxide based method, and arterial and central venous blood gases will be taken regularly throughout the operation. All physiological data will be stored for later analyses and development of the algoritm by machine learning methods. No other invasive interventions will be performed outside our standard clinical peroperative protocol.

NCT ID: NCT06237543 Not yet recruiting - Hypotension Clinical Trials

TAPSE/PASP Anesthesia

TAPSE/PASP
Start date: February 1, 2024
Phase:
Study type: Observational

TAPSE, one of the methods for evaluating right ventricular systolic function; It is a bar parameter that can easily measure apex-basal shortening and provides specific information about global RV function. TAPSE/PASP can be calculated as load-independent parameters to evaluate RV function. Because RV function is sensitive to change in afterload, known as the RV-pulmonary circulation (PC) connection. This study aims to identify patients who are candidates for hypotensive events due to general anesthesia in a hemodynamically stable population.

NCT ID: NCT06231316 Not yet recruiting - Anesthesia Clinical Trials

Preventing Hypotension in the Spine During Cesarean Delivery.

Start date: March 1, 2024
Phase:
Study type: Observational

Examining the advantages associated with the utilization of noradrenaline in preventing spinal hypotension during cesarean births. This involves assessing the positive outcomes and potential benefits derived from incorporating noradrenaline into the medical approach.

NCT ID: NCT06213935 Not yet recruiting - Clinical trials for Post Spinal Anesthesia Hypotension

Preoperative Oral Midodrine Versus Intraoperative Intravenous Norepinephrine in Preventing Post-spinal Anesthesia Hypotension in Cesarean Section: A Prospective Double-blind Randomized Clinical Trial

Start date: February 1, 2024
Phase: N/A
Study type: Interventional

Neuraxial blockade such as spinal anaesthesia can cause severe hypotension due to pharmacological sympathectomy resulting in potential deleterious consequences for the patient, Prevention of this spinal anaesthesia induced hypotension is of utmost importance, Techniques currently in use for preventing hypotension include intravenous fluid prehydration, sympathomimetic drugs, and physical methods such as positioning and leg compression. Midodrine is an orally active α-adrenergic agonist ,Used in clinical management of patients with orthostatic hypotension or hypotension secondary to other clinical conditions or drug therapies. Midodrine is almost completely absorbed after oral administration and undergoes enzymatic hydrolysis to form its pharmacologically active metabolite, de-glymidodrine , causes venous and arterial vasoconstriction through stimulation of α1- receptors located in the vasculature, However ,Midodrine may cause several side effects as chills ,numbness , tingling ,paresthesia ,polyuria ,dysuria and headache. On the other hand, Norepinephrine is a vasoconstrictor that predominantly stimulates α1 receptors to cause peripheral vasoconstriction and increase blood pressure. It also has some β1 receptor agonist activity that results in a positive inotropic effect on the heart at higher doses. Norepinephrine also may cause side effects as headache, blurred vision, chest pain ,nervousness, bradycardia or tachycardia.