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Hypotension clinical trials

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NCT ID: NCT04703088 Not yet recruiting - Hypotension Clinical Trials

ONDANSETRON AND EFFECTIVE DOSE IN 50% OF SUBJECTS OF PROPHYLACTIC NOREPINEPHRINE INFUSIONS FOR PREVENTING SPINAL ANESTHESIA-INDUCED HYPOTENSION DURING CESAREAN DELIVERY

Start date: June 2021
Phase: Phase 3
Study type: Interventional

Spinal anesthesia is the preferred technique for elective cesarean section as per ASA guidelines. Hypotension is the main complication of this technique and is secondary to both sympatholysis and its associated decrease in systemic vascular resistance and to the Bezold-Jarisch reflex, which causes hypotension and bradycardia in response to noxious stimuli detected in the cardiac ventricles. In pregnant patients, spinal anesthesia induced hypotension is worsened by compression of the aorta and inferior vena cava by the gravid uterus. In this setting, hypotension could lead to uteroplacental hypoperfusion and fetal distress. In its 2020 guidelines for enhanced recovery after cesarean section, SOAP states that preventing spinal-induced hypotension is an important strategy to enhance maternal and neonatal outcomes in cesarean delivery Recent studies showed that 5-hydroxytryptamine-3 receptor antagonists, mostly used as nausea and vomiting prophylaxis agents, also contributed to inhibit the Bezold-Jarisch reflex and its associated hemodynamic consequences. Ondansetron is the most studied molecule in this field. Many recent studies and meta-analyses show renewed interest in the use of norepinephrine as a first line agent for preventing and treating spinal anesthesia-induced hypotension in obstetric anesthesia practice instead of phenylephrine. Norepinephrine has the advantage of a better cardiac output and cardiac frequency as compared to phenylephrine without any fetal side effect. The combination of ondansetron and phenylephrine for the prevention of spinal anesthesia-induced hypotension has been studied, but not the combination of ondansetron and norepinephrine. The main objective of this study is to evaluate the sparing effect of a standard dose of ondansetron on norepinephrine consumption during elective cesarean section under spinal anesthesia by determining the effective dose in 50% of subjects (ED50) of a prophylactic norepinephrine infusion after receiving a single dose of 4 mg of ondansetron or a saline control.

NCT ID: NCT04701190 Completed - Hypotension Clinical Trials

Different Noradrenaline Protocols in Post Spinal Hypotension in CS

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

The incidence of hypotension after spinal anesthesia is approximately 60% in parturients undergoing cesarean section. As a consequence of hypotension, nausea-vomiting, dyspnea and neurological deterioration in patients and low Apgar scores in newborns may occur. Therefore, there is an increasing interest to prevent maternal post spinal hypotension by using several drugs including noradrenaline given in different protocols to the patients undergoing spinal anesthesia for cesarean section. However, there is no conclusive answer to the question of which dosage is the best to prevent the maternal post spinal hypotension in literature. In this prospective randomized study, we aimed to compare different noradrenaline protocols for preventing maternal post spinal hypotension during elective cesarean delivery.

NCT ID: NCT04700397 Recruiting - Clinical trials for Ischemic Heart Disease

A Validation Study of Nitroglycerin Induced Acute Drop of Pd/Pa (NTG-Pd/Pa) in Clinical Practice

Start date: January 2, 2021
Phase:
Study type: Observational [Patient Registry]

Hyperemia with adenosine was an elemental process in FFR examination. Adenosine injection will induce some discomfort, and increase cost expenditure. Nitroglycerine will induce an acute drop of Pd/Pa, and this lowest Pd/Pa was determined as NTG-Pd/Pa. NTG-Pd/Pa has a linear relationship with FFR value and has a good diagnostic accuracy to predict FFR≤0.80 in our recent study. There is only one prospective study report on the relationship between NTG-Pd/Pa and FFR. In this study, we aim to evaluate the safety of NTG-Pd/Pa, the repeatability and dose-response of this novel index. Furthermore, we will investigate the diagnostic accuracy of NTG-Pd/Pa, with FFR≤0.8 and Resting full-cycle ratio≤0.89 as ischemic threshold respectively.

NCT ID: NCT04697498 Recruiting - Chronic Pain Clinical Trials

Bilateral Bi-level Erector Spine Plane Block as a Component of General Anesthesia in Surgical Correction of Spinal Deformations

BBESPB
Start date: December 16, 2020
Phase: N/A
Study type: Interventional

Improving the anesthesiology management for surgical correction of spinal deformations with introducing the diagnostic methods and treatment strategy of acute pain, preventing the evolution of chronic pain. Development and implementation in clinical practice perioperative intensive care protocols for surgical correction of spinal deformities.

NCT ID: NCT04692870 Completed - Hypotension Clinical Trials

Association Between Preoperative Shock Index and Hypotension After Spinal Anaesthesia for Non- Elective Caesarean Section

Start date: January 6, 2021
Phase:
Study type: Observational

This is a prospective observational study done in parturient planned for non-elective caesarean section. Association between shock index (HR/SBP) and post-spinal hypotension in parturient undergoing non-elective caesarean section will be evaluated in this research.

NCT ID: NCT04688450 Active, not recruiting - Clinical trials for Hypotension and Shock

BP Management System User Acceptance Testing

Start date: January 21, 2021
Phase: N/A
Study type: Interventional

This is a feasibility study for an investigational clinical decision support system ("the System") intended to optimize the management of blood pressure (BP) for patients during vasopressor infusion. The investigational outcomes are the perceptions of the nurse-subjects who are managing the BP of the patient-subjects; the operational performance of the System; and any technical failures of the software during real-time operation.

NCT ID: NCT04682717 Completed - Clinical trials for Hypotension on Induction

Perfusion Index as a Predictor of Postinduction Hypotension of General Anesthesia in Geriatric Patients

Start date: December 1, 2020
Phase:
Study type: Observational

The influence of hemodynamic aberrations during anesthesia on adverse outcomes is an important clinical issue. There is evidence that hypotension and hypertension during general anesthesia are independently associated with adverse outcomes in patients having both noncardiac and cardiac surgery.One of the intervals of general anesthesia during which hypotension is prevalent is the period after the induction of anesthesia but before the onset of surgical stimulation. This period is particularly prone to decreased vigilance with regard to hemodynamic changes. Statistically significant predictors of hypotension 0-10 min after anesthetic induction included: ASA III-V, baseline MAP <70 mm Hg, age > or =50 years, the use of propofol for induction of anesthesia, and increasing induction dosage of fentanyl.While the potential preoperative factors associated with hypotension 5-10 min after the induction of anesthesia in patients with ASA I-II included baseline MAP 70 mm Hg, age > 50 years, use of propofol during induction, and magnitude of fentanyl dose during induction. Perfusion index (PI) is a relatively new parameter estimating the pulsatility of blood in the extremities, calculated using infrared spectrum as part of plethysmography waveform processing. It is a simple,cost-effective and non-invasive method of assessing peripheral perfusion determined by the percentage of pulsatile to non-pulsatile blood flow in the extremities. PI indicates the status of the microcirculation which is densely innervated by sympathetic nerves, and therefore, is affected by multiple factors responsible for vasoconstriction or vasodilatation of the microvasculature.It is an indicator of systemic vascular resistance (SVR). PI is said to be useful in monitoring depth of anesthesia, hypothermia, successful epidural placement in parturients, adequate relief from ureteric obstruction, response to fluid therapy in critically ill and intraoperative patients and adequacy of circulation in newborn.The value of PI is inversely related to the vascular tone, though not in a linear fashion. Therefore, vasodilatation reflecting higher baseline PI has been associated with reductions in blood pressure (BP) following spinal anesthesia.The resting SVR can influence incidence and severity of post-spinal hypotension in parturients. It has been established that a positive correlation between pre-anesthetic plethysmographic variability index (PVI) and reduction in BP following induction of anesthesia using propofol in healthy adults, that is, higher PVI was associated with more mean arterial pressure (MAP) reductions. Similarly, a significant proportion of hypotension after induction of anesthesia with propofol can be attributed to the baseline SVR. Mehandale SG. and Rajasekhar P. underwent A prospective observational study on fifty adults for the use of Perfusion index as a predictor of hypotension following propofol induction and revealed that a baseline PI <1.05 predicted incidence of hypotension at 5 min with sensitivity 93%, specificity 71%, positive predictive value (PPV) 68% and negative predictive value (NPV) 98%. the hypothesised was that it is possible to define a threshold baseline value of PI that predicts hypotension based on individual's pre-induction SVR in patients > 65 years old following anesthetic induction with propofol and fentanyl as multifactorial risk for postinduction hypotension. Outcomes: A cut-off value of baseline PI below which hypotension at 5 min post induction could be predicted will be the primary outcome, while positive and negative predictive values at 15 minutes will be secondary outcomes.

NCT ID: NCT04680039 Completed - Clinical trials for Hypotension of Hemodialysis

Early Warning of Intradialytic Hypotension in Hemodialysis Patients

Start date: January 15, 2021
Phase:
Study type: Observational

In this study, the investigators will monitor patients undergoing hemodialysis treatment with a non-invasive wearable PPG-based device. Measurements will include blood pressure, heart rate, oxygen saturation, stroke volume, cardiac output, cardiac index and systemic vascular resistance, among others. The aim is to diagnose intradialytic hypotension more rapidly than with current noninvasive methods and prevent related poor outcomes.

NCT ID: NCT04676152 Completed - Healthy Clinical Trials

Validation of Noninvasive Blood Pressure Device

Start date: October 5, 2020
Phase: N/A
Study type: Interventional

This is a prospective, nonrandomized multi-center study for the investigation of noninvasive sphygmomanometers. The purpose of the study is to validate the clinical performance of the Masimo noninvasive blood pressure device compared to reference auscultatory measurements.

NCT ID: NCT04673253 Completed - Hypotension Clinical Trials

Can Passive Leg Raise Prevent Spinal Anesthesia-induced Hypotension During Cesarean Section?

Start date: November 15, 2020
Phase: N/A
Study type: Interventional

All over the world, spinal anesthesia is widely used in cesarean sections due to its superiority over general anesthesia. Due to reasons such as increased sensitivity to local anesthetics and increased intra-abdominal pressure in pregnant women, the frequency of hypotension increases by up to 70%. As a result of the blockage of sympathetic vasoconstrictor fibers originating from T1-L2 segments, loss of peripheral resistance, venous ponding occurs, and cardiac output decreases. Also, the level required for cesarean operation is T4 or T5, and the possibility of affecting the cardiac accelerator fibers, so bradycardia due to the increase in parasympathetic activity may deepen the hypotension. If postspinal hypotension is not managed correctly, it may lead to maternal and fetal complications. In addition to classical methods such as fluid loading and prophylactic vasoconstrictor application to prevent hypotension in pregnant women after spinal anesthesia, techniques such as wrapping the lower extremity, lifting, or applying both together have been in question. Passive leg raise application is an easy method that allows the blood collected in the lower part of the body to participate in the central circulation with the effect of gravity. An increase in venous return occurs with the passage of blood from the lower extremities to the thorax. Thus, it leads to an increase in stroke volume and an increase in cardiac output. In this study, we aimed to determine the effectiveness of passive leg raising in preventing or reducing the depth of hypotension after spinal anesthesia in pregnant women who underwent cesarean section under spinal anesthesia.