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Spinal Anesthesia clinical trials

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NCT ID: NCT05305248 Completed - Sedation Clinical Trials

Sedation With Remimazolam During Spinal Anesthesia

Start date: April 19, 2022
Phase: N/A
Study type: Interventional

Remimazolam is a benzodiazepine-binding site antagonist of the GABA receptor, metabolized by esterases, and exhibits a stable context-sensitive half-life of 6-7 minutes. Remimazolam has a high clearance rate and a small volume of distribution in the pharmacokinetic model. The US FDA has approved sedation for surgery. Although there have been studies on the use of remimazolam as a sedative for procedures such as endoscopy, there have been no reports of the use of remimazolam in spinal anesthesia. The purpose of this study is to compare and analyze the hemodynamics and recovery profile of patients undergoing surgery under spinal anesthesia by maintaining sedation with dexmedetomidine or remimazolam.

NCT ID: NCT05277220 Not yet recruiting - Spinal Anesthesia Clinical Trials

Evaluation of the Recovery of the Sympathetic Block After Spinal Anesthesia by Thermographic Image

THERMOSYMPA
Start date: March 2022
Phase:
Study type: Observational

Spinal anesthesia is a locoregional perimedullary anesthesia which consists of temporary interruption of nerve transmission within the subarachnoid space. This anesthesia is produced, via a lumbar puncture, by injecting a solution of local anesthetics into cerebrospinal fluid. Spinal anesthesia generates installation of three consecutive blocks: (i) a sympathetic block (vasodilation, increased skin heat in the sleeping area, arterial hypotension); (ii) a sensory block (i.e. a sensory paralysis: no pain or sensations at the incision), the level of which is assessed by the "touch" test and (iii) a motor block (a motor paralysis : immobility of the limb at the incision) measured by the Bromage score. Spinal anesthesia is a common method of anesthesia in orthopedic surgery of the lower limbs, as demonstrated by field practice at the Surgical Center Emile Gallé (CCEG). This mode of anesthesia is an alternative to general anesthesia, especially because of a higher benefit / risk ratio. Patients at high-risk will be referred preferentially to a spinal anesthesia to prevent complications related to general anesthesia. If the regulatory conditions are met (formalized expert recommendations 2009), some orthopedic procedures can be performed in the context of day hospitalization. The constraints of day hospitalization involve the use of anesthetic agents or doses compatible with a short duration of action equivalent to the duration of the act of surgery. They must allow a duration of action of maximum 4 hours, a predictable extension of the block at the T10 level (at the sensory level of the umbilicus), a short period of autonomy in ambulation, a rapid recovery from the dysfunction bladder and absence of hemodynamic effects. The return to normal motor function is the sine qua non of fitness for the street. The discharge from the post-intervention monitoring room of a patient operated on under spinal anesthesia is validated once the recovery of the 3 blocks has been objectified : the motor block (bromage score), the sensory block (touch test) and the sympathetic block ( hemodynamic parameters). One of the side effects associated with spinal anesthesia is the installation of a sympathetic block causing more or less significant hemodynamic variations. In current practice, its recovery is objectified when the hemodynamic parameters (FC, PNI) postoperatively (measured every 10 minutes) differ by less than 15% from the basic parameters pre-locoregional anesthesia (LRA). This evolution (with a threshold value of 15%) of the hemodynamic parameters constitutes the reference test (Gold Standard) to objectify a recovery of the sympathetic block. In reality, the criteria on which the recovery of the sympathetic block is based are imperfect because side effects (low blood pressure, nausea, vomiting) can be observed when returning to the outpatient surgery sector's, indicating the presence of a residual block. Data from literature suggest that thermography would be an interesting alternative tool for evaluating the effectiveness of a nerve block after locoregional anesthesia (LRA). Installation of a nerve block is objectified by the change in temperature of the blocked body areas. In fact, the sympathetic block causes vasodilation in these areas and therefore an increase in local temperatures visible on thermography. Concretely, performed before locoregional anesthesia (LRA), thermography gives a basal body mapping of local temperatures. These are the reference temperatures. After performing locoregional anesthesia, the sympathetic block sets in and causes vasodilation which is itself responsible for an increase in local temperatures (appearance of warm colors on the body map). Then the return to the initial temperatures (i.e. those observed at the preoperative time) is done gradually as the sympathetic block recovers. Use of the thermographic method to detect the recovery of sympathetic block after spinal anesthesia has never been evaluated. However, by comparison to these preoperative images, thermography could allow the detection of areas of local temperatures that are still high postoperatively (persistence of hot colors on the body map), while a return to basic local temperatures is expected. (neutral or cool colors). This could alert to the persistence of a residual sympathetic block, with areas of the body where vasodilation persists despite the return to normal of hemodynamic parameters, and prevent complications in outpatient surgery sector's. Main research hypothesis of the investigators is that thermographic image evaluation has very good sensitivity for the recovery of sympathetic block after spinal anesthesia compared to the reference method based on hemodynamic parameters. In addition, second research hypothesis of the investigators is that the recovery of the residual sympathetic block evaluated by thermographic image can reduce the occurrence of subsequent adverse events.

NCT ID: NCT05240846 Recruiting - Obesity, Morbid Clinical Trials

Spinal Anesthesia Using Ultrasound Assistance Versus Conventional Palpation in Morbidly Obese Patients

Start date: February 23, 2022
Phase: N/A
Study type: Interventional

The aim of this study is to compare the paramedian approach for spinal anesthesia using ultrasound assistance (USAS) versus conventional palpation in morbidly obese patients undergoing elective surgeries.

NCT ID: NCT05133648 Active, not recruiting - COVID-19 Clinical Trials

Anesthesia Technique in COVID-19 Positive Hip Fracture Patients

Start date: January 5, 2023
Phase:
Study type: Observational

Patients with COVID undergoing hip fracture repair have high mortality rates. If spinal anesthesia is associated with decreased rates of mortality, this study could provide hypothesis generating data for prospective studies. Investigators hypothesize that spinal anesthesia (SA) is associated with decreased mortality compared to general anesthesia (GA) for patients undergoing hip fracture surgery. The primary objective is to determine for patients undergoing hip surgery with COVID-19 infection, whether SA, as compared to GA, is associated with a lower rate of mortality 30 days postoperatively. The secondary objective is to determine whether SA, as compared to GA, is associated with a lower rate of morbidity 30 days postoperatively. Investigators will be analyzing a data set provided by the National Surgical Quality Improvement Program (NSQIP). Descriptive statistics will be performed. Multivariable logistic regression will be performed for the primary and secondary objectives.

NCT ID: NCT05133271 Recruiting - Spinal Anesthesia Clinical Trials

Prediction of Maternal Arterial Hypotension After Spinal Anesthesia by Passive Leg Raise Test.

EDLIDL
Start date: February 3, 2021
Phase: N/A
Study type: Interventional

Spinal anesthesia for cesarean section is associated with a high incidence of low blood pressure. However, the pathophysiology of this arterial hypotension is not unequivocal and could involve, in addition to drug vasoplegia, a mechanical cause linked to lower caval compression or even true or relative hypovolemia. Passive leg raise test has been proposed in an attempt to identify parturients who are more likely to develop low blood pressure after spinal anesthesia. Nevertheless, the data available on this volume expansion test to predict hemodynamic variations after performing spinal anesthesia are still limited and few objective criteria have been described to predict this arterial hypotension. The objective of the research is to study the hypothesis according to which the presence of hypovolaemia (true or relative) objectified by a positive passive leg raise test would cause hypotension more frequent and more marked in intensity.

NCT ID: NCT05063292 Not yet recruiting - Spinal Anesthesia Clinical Trials

Effect of Prewarming On Skin Temperature Changes

Start date: October 5, 2021
Phase: N/A
Study type: Interventional

In this randomized prospective single-blind study,American Society of Anesthesiologists physical status classification system ( ASA )I-II-III patients aged 50-80 years undergoing transurethral bladder resection will be randomly divided into two groups. First group will be covered with 41 centigrade degrees double layered cotton cloth. Second group will receive active prewarming. Core temperature of all patients will be monitorized via tympanic membrane. Skin temperature will be monitorized from 4 different body areas. Spinal anesthesia will be applied at the level of L3-L4 by a 25 Gauge quincke needle with a dose of 12.5-15 mg hyperbaric bupivacaine. Pinprick test will be used for sensorial block assessment. T10 sensorial block will be our goal. Hemodynamic parameters will be recorded. Skin temperature will be monitorized before and after spinal anesthesia and changes will be recorded. Operation time, amount and temperature of irrigation fluids, transfusion requirement, discharge time from postoperative care unit will also be recorded. Shivering score and thermal comfort scale will be used. The two groups will be compared for the temperature changes.

NCT ID: NCT05002257 Recruiting - Spinal Anesthesia Clinical Trials

Impact of Listening to Music on Anxiety Postoperative in a Postanesthesic Care Unit (PACU) After Spinal Anesthesia

MusicAnx-SSPI
Start date: May 25, 2021
Phase: N/A
Study type: Interventional

Our hypothesis is that listening to music has a beneficial effect on the French population receiving spinal anesthesia for a scheduled procedure. We think we can reduce anxiety when switching to SSPI, using creative music therapy software (Music Care) French validated by clinical research.

NCT ID: NCT04975386 Not yet recruiting - Spinal Anesthesia Clinical Trials

Echocardiography Examination Of The Cardiac Effects Of Different Regional Anesthesia Methods

Start date: July 29, 2021
Phase: N/A
Study type: Interventional

Nerve blocks applied with neuraxial anesthesia and ultrasonography are used for many operations today. Neuraxial blocks cause varying degrees of decrease in the blood pressure level of the patients. Peripheral blocks may be preferred to avoid the cardiac effects of the neuraxial anesthesia method.

NCT ID: NCT04806997 Completed - Spinal Anesthesia Clinical Trials

Changes in the Microvascular Reactivity on Leg During Spinal Anesthesia

Start date: December 29, 2016
Phase:
Study type: Observational

Anesthesia alters microcirculation and tissue oxygen saturation (StO2). We sought to examine changes in StO2 using near-infrared spectroscopy and a vascular occlusion test (VOT) during spinal anesthesia. This prospective observational study was included 51 patients without comorbidities who underwent elective surgery under spinal anesthesia. We measured the StO2 in the lower extremity during VOT before and after intrathecal injection.

NCT ID: NCT04778189 Completed - Spinal Anesthesia Clinical Trials

Effect of Intravenous Dexamethasone on Duration of Hyperbaric Bupivacaine Spinal Anesthesia in Lower Abdominal Surgery

Start date: December 1, 2021
Phase: Phase 2
Study type: Interventional

The use of dexamethasone, administered either systemically or perineurally, as an adjunct to peripheral or neuraxial regional blocks, is currently one of the hottest topics in the field of regional anesthesia.