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NCT06729827
Single shot spinal anesthesia (SA) is the most commonly used technique for Caesarean section (CS) . SA is associated with maternal hypotension (Post Spinal Hypotension - PSH) often accompanied by nausea, vomiting, bradycardia and fetal acidosis. Preventive administration of vasopressors is widely used to counterbalance hypotension. Routine prophylactic infusion of phenylephrine and norepinephrine raises concerns for unnecessary treatment, reactive hypertension, baroreceptor-mediated bradycardia, and effects on fetal acidosis. Non-invasive continuous measurement of arterial pressure using a finger cuff is well established. Hypotension Prediction Index - HPI is an algorithm that could predict the onset of hypotension in working on invasive and non-invasive arterial waveform signal. The aim of this prospective randomized study is to compare the amount of PSH during elective caesarean section among two groups of patients receiving standard intermittent hemodynamic monitoring versus continuous ClearSight-HPI monitoring. The primary hypothesis is that hemodynamic management HPI-guided reduces the incidence, entity and duration of post-spinal hypotension, defined as mean arterial pressure (MAP) lower than 65 mmHg lasting more than one minute. The secondary aim was to study the impact of maternal PSH during CS on foetal outcome evaluated by comparing neonatal Apgar scores at 1 and 5 minutes after birth, and umbilical cord arterial and venous pH in the two groups.
NCT07370103
Baseline Measurements For the ultrasound parameters, it is the average of three readings In supine position . The investigators will continuously monitoring during induction and 10 minutes after. Hemodynamic Monitoring: * Heart rate from ECG * SpO2 * Etco2 * Blood pressure . invasive Blood pressure * The radial artery level is the site of continuous arterial pressure monitoring with an arterial catheter. * Ultrasound Measurements: The patient will be positioned in a supine position, with the right side of the neck completely exposed. The transverse part Of the main carotid artery beneath the thyroid cartilage will be precisely identified using ultrasound device (sonosite edge portablp.fojy usa)via a linear array probe (4-15 MHz), with the marker directed toward the patient's head. Thus, the sampling line will be positioned at the center of the carotid lumen, around 2 cm from the carotid bifurcation, and the electronic angle correction cursor will be pointed in the direction of blood flow. Insonation angles between the ultrasound beam and blood flow will be maintained at or \< 60°. Next, the carotid blood flow waveform will be acquired, and the consecutive stable carotid pulse Doppler flow spectrum will be determined with an optimal level of image quality. The Correction: To get the corrected carotid flow time (ccFT), the measured FT will be adjusted for the patient's heart rate (HR). A commonly used formula is Wodey's formula. A single, experienced sonographer will perform all measurements, and a subset of measurements will be reviewed by a second blinded observer to assess inter-rater reliability." Peak Velocity: Measure the peak systolic blood flow velocity at the same location. Respiratory Variation (ΔVpeak): Calculate the difference between the maximum and minimum peak velocities during a single respiratory cycle: \\Delta V\_{peak} = (V\_{peak(max)} - V\_{peak(min)}) / ((V\_{peak(max)} + V\_{peak(min)})/2) \\times 100\\%. The patient should be asked to breathe normally during this measurement. Flow time (FT), which is known as the time period between the systolic increase phase and dicrotic notch, was calculated and then adjusted for heart rate (HR) via equations outlined below. Wodey's (W) equation∶ FTc(W) = FT + 1.29 ∗ (HR - 60) Anasthesia: Patients will have routine fasting for at least 6 to 8 h and will not allowed to drink any solution or fluid 2 to 4 h prior to surgery. No premedication will be given A standardized induction protocol will be used. At the operating theatre, a three-lead electrocardiogram (ECG), pulse oximetry (SpO2), and noninvasive arterial pressure monitoring will be applied. After pre-oxygenation for 5 min anesthesia induction of propofol 1\_2mg , fentanyl 1 ug/kg, and 0.15 mg/kg cisatracurium . After 3 min of mask ventilation, direct laryngoscopy will be employed for tracheal intubation. . Respiratory setting of anesthesia machine (Aestiva, GE/Datex-Ohmeda) will be set as follows: volume-controlled ventilation (VCV), inspiratory-expiratory (I:E) ratio of 1:2, respiratory rate of 8-10 bpm, tidal volume of 8 mL/kg of ideal weight \[45.5 + 0.91x (height in cm-152.4)\], and PEEP of 5 cm H2O in 50% oxygen with air. Respiratory settings will be adjusted to maintain the PETCO2 at less than 50 mmHg. Anesthesia will be maintained with sevoflurane (1.5-2.5%) and intermittent injection of cisatracurium 0.02mg/kg as needed to keep the entropy scale between 40 and 60 and for muscle relaxation. The mean arterial pressure was kept between 60 and 80 mmHg. Hemodynamic Data Collection: Invasive mean arterial pressure (MAP) will be continuously recorded for 5-10 minutes post-induction. Hypotension Definition: Hypotension will be defined as a decrease in MAP by \>20% from the baseline value or an absolute MAP of \<65 mmHg for more than one minute.This definition is clinically relevant and widely used in the anesthesia literature. Postinduction hypotension will be treated with 250 ml saline iv boluse repeated if successfully restore blood pressure. If refractory to fluid we will inject intravenous ephedrine in 3 mg bolus doses and repeated when necessary. Significant bradycardia (heart rate \< 40 beats/min) will be treated with intravenous boluses of atropine (0.5 mg). Study duration 3 months or end of recruitment of sample
NCT06814054
In this observational study, we will assess cFT by Carotid ultrasound and IVC collapsibility index for prediction of hypotension after induction of general anesthesia in geriatric patients undergoing elective surgery.
NCT06426784
C-section is one of the commonly performed surgical procedures. During this surgical procedure the surgeon cuts into uterine cavity through abdominal wall and takes out the baby. This is done by by making the lower half body of the patient numb by injecting local anesthesia drugs into the space surrounding the spinal cord. This allows the mother to remain awake and immediately bond with the baby once it gets delivered. Also this technique provides effective pain relief both during and after the surgery. However like any other technique or drug it is associated with a number of side effects. The most important being fall in blood pressure. There are numerous ways to treat it. However if one is able to predict fall in blood pressure before administration of anesthetic technique one can easily prevent it. One of the recently discovered novel way to predict fall in blood pressure is Perfusion index which is calculated by Pulse oximeter. It is a device use to check amount of oxygen in blood and heart rate. Perfusion index refers to the total amount of blood present in the limbs of the person. Once we administer drug in the space surrounding the spinal cord the amount of blood in the limbs increases while the amount returning to heart decreases which ultimately results in less amount of blood being pumped out by heart resulting in fall in blood pressure. Therefore theoretically those individuals who have a high baseline Perfusion index will more likely to develop low blood pressure. This study aims to identify the cut off value of perfusion index to predict fall in blood pressure.
NCT06787404
The goal of this observational study is to compare post-induction hypotension treatments with PRAM method in Gynecologic Oncological Cases. The goal of this observational study is to compare post-induction hypotension treatments with PRAM method in Gynecologic Oncological Cases.
NCT05969886
Post-induction hypotension (PIH) is a common occurrence during the period from induction of general anesthesia to initiation of incision. PIH has been identified as an independent risk factor for postoperative major complications. Identifying high-risk patients for PIH could potentially help prevent its occurrence. Several risk factors associated with PIH have been identified, including patient conditions and use of specific anesthetic agents. Ventricular-arterial coupling (VAC) is evaluated using the ratio Ea/Ees and represents the interaction between the left ventricle (LV) and the arterial system. It reflects how changes in LV contractility (Ees) and changes in arterial load (Ea) work together to maintain optimal LV performance. A study aims to investigate the relationship between preoperative Ea/Ees ratio and the incidence of PIH (defined as MAP \< 65 mmHg).
NCT05842759
In this clinical proof-of-concept study, the aim is to investigate the efficacy of a hypotension avoidance strategy to prevent post-induction hypotension. Specifically, it will be investigate how much postinduction hypotension occurs when using a hypotension avoidance strategy - combining continuous intraarterial blood pressure monitoring, careful administration of anesthetic drugs, and continuous administration of norepinephrine to treat hypotension - in high-risk patients having elective non-cardiac surgery.
NCT05536323
Remimazolam is a newly introduced intravenous anesthetic, with rapid onset and offset. Although it is known to cause less hemodynamic instability, the incidence hypotension is the one of the most frequent adverse events with its use. For anesthetic induction, remimazolam can be used either as bolus dose or as continuous infusion. This study is aimed to investigate the incidence of hypotension after anesthetic induction with bolus (0.14-0.33 mg/kg) or continuous (12 mg/kg/hr) remimazolam administration.
NCT05884918
The primary objective of this observational study is to investigate the risk factors for intraoperative hypotension and identify the underlying pathomechanisms leading to it, both during the period after general anesthesia induction and throughout its course. The main questions it aims to answer are: * how frequent is intraoperative hypotension * what are the underlying pathomechanism causing it The study is including patients who have been identified as having a high risk of perioperative complications (ASA3 or ASA4). Patients included in the study undergo advanced hemodynamic monitoring during the procedure. Anesthesia induction, maintenance, and termination are conducted by an anesthesiologist in accordance with current medical knowledge, and the planned experiment does not in any way influence the course of action. Investigators will analyse medical documentation, including the patient's medical history, anesthesia records, and hemodynamic parameter data obtained from the hemodynamic monitor (an Excel file containing comprehensive data related to specific cardiovascular parameters) to describe the incidence of intraoperative hypotension and answer key questions in accordance with the designed study protocol.
NCT05424510
Hypotension is a common side-effect of general anesthesia induction, and is related to adverse outcomes, including a significantly increased risk of one-year mortality. Hypovolemia is a significant risk factor, and optimized fluid therapy remains the cornerstone of its treatment. Ultrasound measurements of inferior vena cava (IVC) diameter with respiration have been recommended as rapid and noninvasive methods for estimating volume status. Several recent studies reported that preoperative IVC ultrasound has a reliable predicting ability of arterial hypotension after the induction of general anesthesia. The practical effect of optimizing fluid status before surgery using this ability has not been studied. Our hypothesis is that preoperative ultrasound-guided intravenous fluid bolus administration may reduce the incidence of hypotension after the induction of general anesthesia in adults presenting for elective non-cardiac, non-obstetric surgery
NCT05497700
Hypotension occurs frequently after anesthesia induction and is more frequent in patients with chronic renal insufficiency. This hypotension occurs most frequently during the 20 minutes after anesthesia induction. Hypotension is commonly corrected by ephedrine bolus injection. However, presynaptic noradrenaline reserve may be lower in patients with chronic renal insufficiency rendering this treatment less effective. Another drug commonly used is norepinephrine, which action is independent of presynaptic noradrenaline storage. The primary hypothesis is that in patients with chronic renal insufficiency, bolus injection of norepinephrine will be more effective then ephedrine injections to correct hypotension after anesthesia induction. 60 patients with a glomerular filtration rate less than 45 mL/min/m2 (KDIGO classification less than grade 3b) will be included in this prospective double blind trial. All patients will be anesthetized by target-controlled infusion of propofol adjusted to a patient state index (Measured by Sedline, Masimo) of 25-50. Sufentanil injection will be based on noxious stimuli according to the attending anesthesiologist's judgement. Non-invasive blood pressure will be measured at the pre-anesthesia clinic, before induction and every minute up to 20 minutes post anesthesia induction. Episodes of hypotension, defined as a mean arterial blood pressure less than 65 mm Hg, will be treated either by a bolus injection of 6 mg ephedrine or a bolus injection of 6 mcg norepinephrine, which are equipotent doses. Seringues containing either ephedrine 3 mg/mL or norepinephrine 3 mcg/mL will be prepared by an anesthesia nurse not involved in the care of the patient and labeled as "VASO-IRC-inclusion number". Randomization will be done by a computer generated list in a block randomization of 5. Primary outcome is the number of boluses needed to maintain arterial blood pressure above a mean of 65 mm Hg.
NCT04603469
Children generally undergo induction of anesthesia by inhalation of sevoflurane. Children with Down Syndrome experience bradycardia with induction of anesthesia using sevoflurane. It is unknown if this bradycardia is isolate or results in hypotension, thus requiring treatment. Isolate bradycardia without hypotension does not require treatment and should be avoided as many of these patients have underlying cardiac anomalies.
NCT04573842
Intra operative hypotension is a risk factor in pediatric anesthesia (McCann ME et al.Pediatr Anesth 2014; 24: 68-73). In summary, the study aims at examine if ultrasound assessment of the diameter and collapsibility index of the subclavian vein is correlated to fasting time and if they are correlated to the degree of hypotension seen post anesthesia induction in children undergoing general anesthesia.
NCT04051073
Background During anaesthesia for repair of a broken hip, many patients experience low blood pressure. There have been many studies showing that patients who experience low blood pressure during anaesthesia are at increased risk of sustaining kidney or heart damage, strokes, having a post-operative infection, or dying. During anaesthesia, in most cases blood pressure is monitored using a cuff which inflates on the arm (the 'normal' way blood pressure is measured in a GP practice or hospital ward). This gives a reading each time the cuff goes up and down, every 3-5 minutes typically. There is a less well used way to measure blood pressure, using an additional cuff on the finger which gives a constant, continuous measure of blood pressure. We think that using this monitor, rather than the 'standard' monitor, will mean that low blood pressure is recognised more quickly, therefore treated more quickly, and will lead to patients having less exposure to dangerously low blood pressures. If this is the case, we hope that it will reduce how often patients experience kidney or heart damage, have an infection after surgery, suffer a stroke, and reduce the risk of death. Methodology To test this, we would need to run a large clinical trial comparing the continuous monitor to the standard monitor. This would be expensive and involve a great deal of work in a large number of hospitals, and so first we wish to determine whether the trial we would like to run is practical, and possible to deliver in the real world. To do this we plan to run the trial first on a small-scale feasibility (pilot) study, where we will recruit 30 patients, half of whom will have the standard monitor, and half of whom will have the continuous monitor. We will see what proportion of the patients who could enter the trial actually do so and complete it, and use it as an opportunity to iron out problems with the trial. If we find it is possible to run the trial on a small scale, we will apply for funding to run a full study. This will aim to answer the question of whether the continuous monitor improves the patient outcomes which were agreed during development with the patient public involvement group locally; rate of kidney damage, heart damage, stroke, post-operative infections, risk of death, and hospital length-of-stay. Expected outcomes and implications. We anticipate we will find the trial to be feasible with amendments to the way it is run, and if this is the case, we will apply to run the full scale trial. If this shows that using the continuous monitor improves the patient outcomes above, then it would represent new, significant evidence that may lead to the NHS adopting it's use as 'standard care' during anaesthesia for repair of a broken hip, and would like lead to similar trials in other operations where patients may benefit in a similar way.
NCT04682717
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.
NCT04291794
To compare haemodynamics and bispectral index values between conventional bolus propofol induction and target-controlled propofol infusion.
NCT03580590
* The primary endpoint is the effect of the addition of oral Diltiazem and Tranexamic Acid to general anesthesia aided reduction in blood loss during functional endoscopic sinus surgery (FESS). * The secondary endpoint is surgeon's assessment of the surgical field and hemodynamics.