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Hypotension clinical trials

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NCT ID: NCT05405608 Not yet recruiting - Clinical trials for Bone Cement Syndrome

The Effect of iv Ondansetron on Reducing Hypotension Due to BCIS in Total Knee Prosthesis Surgery

Start date: June 2022
Phase:
Study type: Observational

Bone cement implantation syndrome (BCIS) is a complication associated with the implantation of polymethylmethacrylate bone cement. Hypoxia, hypotension, and/or unexpected loss of consciousness often result from cementation, prosthetic placement, joint reduction, or tourniquet removal; It is a major cause of intraoperative and postoperative morbidity and mortality. Therefore, reducing the occurrence and severity of BCIS is an important issue. BCIS is mainly known for its association with hip hemiarthroplasty, total hip arthroplasty (TKA), and vertebroplasty, but is also seen during total knee arthroplasty (TKA). The incidence and associated mortality of BCIS has been investigated only in cemented hemiarthroplasty after displaced femoral neck fractures and in operations performed with cemented TCA and hemiarthroplasty in cancer patients. To our knowledge, the incidence associated with BCIS (compared to hemiarthroplasty or TKA), associated factors, and mortality for other hips, knee, or shoulder arthroplasty is not yet known. Little is known about the incidence, mortality risk, and factors associated with the development of BCIS during hip hemiarthroplasty and cemented arthroplasty procedures other than primary TKA. The pathophysiology of BCIS is unclear. The first theories focused on circulating MMA monomers; however, recent evidence suggests an embolism-mediated model. Other additional theories focus on the role of histamine release, complement activation, and finally the multimodal possibilities of all these factors together. Ondansetron, a 5-hydroxytryptamine 3 (5-HT3) receptor antagonist, has been given preoperatively and intraoperatively to block serotonin-induced pulmonary vasoconstriction. This study aimed to investigate whether blocking type 3 serotonin receptors with intravenous ondansetron would reduce hypotension due to bone cement syndrome in patients undergoing TKA under combined spinal-epidural anesthesia.

NCT ID: NCT05237856 Not yet recruiting - Clinical trials for Intraoperative Hypotension

The Use of Integrated Pulmonary Index During Cesarean Section Under Spinal Anesthesia

Start date: February 1, 2022
Phase:
Study type: Observational

Postspinal hypotension (PSH) is a common side effect with an incidence of 15.3 to 33% that can result in organ hypoperfusion and ischemic events. In pregnant patients, this incidence may increase to 70% and severe PSH increases the risk of maternal and fetal complications. Therefore, it is extremely important for anesthesiologists to recognize PSH early and treat it quickly during cesarean sections. Integrated pulmonary index (IPI) is an algorithm that has been used recently. IPI takes into account four parameters: respiratory rate, end tidal CO2, heart rate and O2 saturation. Capnography device measuring IPI can continuously monitor and display the patient's respiratory status in a single digit range from 1-10. This index value can be observed continuously on the monitor as digital data or as a waveform. "10" indicates a normal respiratory condition, while "1" indicates that the patient requires immediate intervention. The relationship between values and the patient status is evaluated as follows; 10 = Normal, 8-9 = Normal range, 7 = Near normal range; Requires attention, 5-6 = Requires attention and may require intervention, 3-4 = Requires intervention, 1-2 = Requires immediate intervention. IPI monitorization is mostly used during sedation (gastroscopy, cardioversion), intensive care units (for adjusting mechanical ventilator settings, monitoring the weaning process). As a result, IPI monitoring has attracted attention because it allows non-invasive, dynamic and real-time measurement, reflects respiratory status with high specificity and sensitivity, and enables respiratory problems to be detected earlier. End tidal CO2, which is one of the 4 parameters that IPI value takes into account, is a parameter that can be used to evaluate the effectiveness of ventilation, but is also related to cardiac output (CO) because the delivery of CO2 to the pulmonary system depends on it. Studies have shown that ETCO2 value correlatively decreases when CO decrease, in cases such as hypotension and hypovolemia. We think that ETCO2 will decrease due to pulmonary hypoperfusion in post spinal hypotension and it may cause a change in IPI value. In our study, we will monitor patients who are scheduled for cesarean section under spinal anesthesia with a capnometry device and we will try to determine the significance of IPI monitorization in predicting hypotension.

NCT ID: NCT05166330 Not yet recruiting - Hypotension Clinical Trials

Two Ratios of Propofol-ketamine Admixture for Rapid-sequence Induction Anesthesia for Emergency Laparotomy

Start date: December 2021
Phase: Phase 4
Study type: Interventional

Hypotension during anesthesia is associated with serious organ failure and death. The most critical period for intraoperative hypotension is the postinduction period during which, one-third of intraoperative hypotension occurs. Post-induction hypotension has many contributing factors; however, it is closely related to anesthetic drugs. Therefore, manipulation of induction agents makes post-induction hypotension likely preventable. Emergency laparotomy is a critical category of surgery whose patients are usually hemodynamically compromised and prone to post-induction hypotension; furthermore, these patients are usually at high risk of aspiration of gastric contents and require rapid-sequence induction of anesthesia and optimum intubating conditions. Thus, induction of anesthesia for emergency laparotomy requires meticulous balance between achievement of adequate hypnosis and maintenance of stable blood pressure. Propofol is the commonest hypnotic agent worldwide. However, it is usually associated with hypotension especially in compromised patients. Ketamine produces dissociative anesthesia and sympathetic stimulation which provides more stable hemodynamic profile; however, ketamine is not widely used as a routine hypnotic because it produces psychomimetic effects such as delirium and emergence agitation. Nevertheless, ketamine still has a role in induction of anesthesia in patients with shock and during procedural sedation. Ketamine is also used as analgesic adjuvant during general anesthesia. Propofol/ketamine admixture (ketofol) was introduced in anesthetic practice aiming to compensate the side effects of the two drugs and to provide, consequently, the desired balance between adequate hypnosis and hemodynamic stability. Ketofol is currently used with a diversity in the ratio between the two drugs which ranges between 1:1 and 1:10 between ketamine and propofol. Despite its frequent use in sedation and complete anesthesia, most of the available literature for comparisons of different ketofol mixtures was restricted to procedural sedation whose results are not applicable in induction of anesthesia due to the different desirable level of hypnosis and recovery. Therefore, the best combination of the two components of ketofol for induction of anesthesia is unknown

NCT ID: NCT05120258 Not yet recruiting - Clinical trials for Post Spinal Hypotension

Can Subclavian / Infraclavicular Axillary Vein Collapsibility Index Predict Post-Spinal Hypotension in Caesarean Section Operations?

Cesarean
Start date: November 8, 2021
Phase:
Study type: Observational

Postspinal hypotension (PSH) is a common side effect with an incidence of 15.3% to 33%, which may result in organ hypoperfusion and ischemic events (1,2). In pregnant patients, this incidence may increase to 70% and severe PSH may increase the risk of maternal and fetal complications (3). Therefore, it is important for anesthesiologists to estimate the incidence of PSH in cesarean sections and to identify possible mechanisms (4). One of the important factors affecting the susceptibility of patients to intraoperative hypotension is the preoperative intravascular volume status. Recently, ultrasonography of the central veins has been used frequently by anesthesiologists in the preoperative period in order to evaluate the intravascular volume status (5). Salama and Elkashlan stated that the collapsibility index of the inferior vena cava is a new predictive value for PSH (6). Choi et al. showed that the subclavian vein or infraclavicular axillary vein collapsibility index is an important predictive value for hypotension after induction of general anesthesia (7). In this study, we wanted to investigate whether the subclavian vein or infraclavicular axillary vein collapsibility index can be used as a predictive value for PSH in cesarean section.

NCT ID: NCT05035472 Not yet recruiting - Adverse Effect Clinical Trials

The Potency of Prophylactic Norepinephrine and Phenylephrine Boluses for Postspinal Anesthesia Hypotension

Start date: January 1, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the potency between prophylactic norepinephrine and phenylephrine boluses for postspinal anesthesia hypotension in patients with severe preeclampsia during caesarean section.

NCT ID: NCT04991220 Not yet recruiting - Clinical trials for Hypotension on Induction

Evaluation of the Changes of Pleth Variability Index During Preoxygenation for Predicting Hypotension

Start date: August 30, 2021
Phase: N/A
Study type: Interventional

The aim of this study is to investigate whether the change in pleth variation index (PVI) according to preoxygenation can predict hypotension during anesthesia induction.

NCT ID: NCT04934410 Not yet recruiting - Blood Pressure, Low Clinical Trials

Induction Agent and Incidence of Hypotension in Heart Failure Patients Undergoing LVAD-Implantation

INTENS
Start date: November 1, 2021
Phase:
Study type: Observational

The induction of anesthesia is one of the most critical situations for high-risk-patients undergoing major surgery. For several reasons, it is crucial to maintain adequate blood pressure and cardiac output during this phase. This observational study aims to find out if the choice of the induction agent has a major impact on blood pressure and the use of antihypotensive drugs during the induction and the surgical procedure in heart-failure patients undergoing the implantation of a left ventricular assist device (LVAD).

NCT ID: NCT04908917 Not yet recruiting - Mild Hypertension Clinical Trials

Reducing Air Pollution to Lower Blood Pressure

AIR PRESSURE
Start date: July 1, 2021
Phase: N/A
Study type: Interventional

Fine particulate matter <2.5 μm (PM2.5) air pollution is the fifth leading risk factor for global mortality. Mitigating the clinically significant blood pressure (BP) elevation from air pollution by reducing PM2.5 exposure will likely contribute to the reduction in cardiovascular disease-related mortality. Twin epidemics of air pollution and high BP converge in underserved urban communities (i.e., Detroit) and warrant immediate attention. Prior studies with short duration (a few days) showed indoor portable air cleaners (PACs) are a novel approach to reduce the health burden of both high BP and PM2.5. Trials over several weeks employing remote technologies with a large sample size of patients residing in their own homes in vulnerable urban communities are needed to demonstrate if the BP-reduction from PAC usage is sustainable in real-world settings. The investigators' specific aims are to 1) determine if compared to sham, active PAC use during 3 weeks can provide sustained reductions in home BP levels by reducing personal-level PM2.5 air pollution exposures in patients with mild high BP residing in vulnerable disadvantaged communities across Detroit and 2) explore clinical markers (e.g., age, sex, body mass index) that predict BP-responses to PAC intervention to better target at-risk populations in larger-scale trials and future real-world clinical settings. A randomized, double-blind, sham-controlled parallel limb trial of overnight bedroom PAC use versus sham with 200 Detroit community individuals with mild high BP will be conducted. Continuous bedroom PM2.5 levels and home BP will be measured throughout 28 days. PAC will be used in the bedroom before bedtime on the 7th day continuously for 21 days. The reduction of systolic BP (SBP) will be calculated for both the intervention and control groups and the significance will be compared using mixed-effects modeling with repeated measurements of SBP as the dependent variable and group (active vs sham PAC use) as the independent variable with a fixed-effect. Linear multiple regression modeling with SBP as the dependent variable and participant-level characteristics including body mass index, waist circumference, race, ethnicity, or sex as predictors will be explored. This study is expected to demonstrate a significant sustainable reduction in home SBP for active PAC vs sham use in this population with mildly high BP.

NCT ID: NCT04886089 Not yet recruiting - Clinical trials for Post-induction Hypotension

Pleth Variability Index as a Predictor for Post-induction Hypotension in Elderly Patients

Start date: May 2021
Phase:
Study type: Observational

Hypotension after induction of general anesthesia and before surgical stimulation is a prevalent anesthesia-related side effect. The post-induction hypotension disrupts organ perfusion and may cause organ damage particularly acute kidney injury, cerebrovascular stroke, and myocardial ischemia. Post-induction hypotension occurs with greater frequency and severity in the elderly. This is because of aged-related diminished cardiac reserve and impaired autonomic homeostasis. Pleth variability index (PVI) is a software program that measures the dynamic changes of the PI that occurs during a complete respiratory cycle. Our primary outcome is to determine the predictive ability and the optimal cut-off value of pre-anesthesia PVI for predicting elderly patients who are at risk of developing post-induction hypotension

NCT ID: NCT04839536 Not yet recruiting - Kidney Diseases Clinical Trials

Comparing Sevoflurane With Propofol Sedation in ESRF Patients

Start date: April 1, 2021
Phase: Phase 4
Study type: Interventional

End-stage renal failure (ESRF) cohorts undergo brachiocephalic fistula(BCF) transposition with supraclavicular block. However, this is inadequate because the incision may extend to the axillary region which requires intercostobrachial (T2) dermatome blockage. Sedation is commonly indicated to allay anxiety whilst allowing intraprocedural lignocaine infiltration. It is challenging to administer safe sedation to ESRF patients due to multiple comorbidities, polypharmacy, altered pharmacokinetic drug handling. Intraoperative hypotension can be common and evident from the residual effect of antihypertensive and intravascular hypovolemia from regular hemodialysis. Midazolam is metabolized to an active metabolite which can accumulate causes apnea and delayed recovery. TCI propofol needs higher induction doses to achieve hypnosis causes exaggerated hypotension which may jeopardize organ perfusion. The investigators are exploring the potential benefit of sevoflurane sedation which are independent of renal clearance, rapid onset and offset, and ischemic preconditioning property in ESRF cohorts.