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Anesthesia Awareness clinical trials

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NCT ID: NCT06323616 Recruiting - Anesthesia Clinical Trials

The Effect of Anesthesia Depth Monitoring on Emergence Delirium in Pediatrics

Start date: March 25, 2024
Phase: N/A
Study type: Interventional

Some changes in the patient's cognitive state are observed during the recovery period from general anesthesia. This period of behavioral dysregulation has been called emergence agitation (EA) and emergence delirium (ED). ED and EA occur in the early postoperative period (often within the first 30 minutes). The incidence of ED ranges from 10% to 80% in children and is described as a distressing clinical condition by 42% of pediatric anesthesiologists. Self-harm by the child increases the risk of delayed discharge and may increase the cost of medical care. Sevoflurane is a widely used agent for the induction and maintenance of anesthesia, but its use is associated with the occurrence of ED in the pediatric population. Clinical findings are characterized by hallucinations, struggling, restlessness, crying, and disorientation. In the literature, the Pediatric Anesthesia Rescue Delirium (PAED) Scale Score is used in the diagnosis of ED and EA. This score consists of 5 criteria (maximum score 20) scored using 0-4 point scales. These criteria; The child needs to make eye contact with the caregiver, the child's movements are purposeful, the child is aware of the environment, the child is restless/angry, the child cannot be consoled. While the sensitivity of ≥10 points for the diagnosis of ED is 64% and the specificity is 86%, the sensitivity of >12 points for the diagnosis of ED is 100% and the specificity is 94.5%. Monitoring intraoperative depth of anesthesia in the adult population has been recommended by the American Society of Anesthesiologists (ASA) due to its potential benefits such as faster recovery time and lower drug dosage, as well as prevention of adverse effects such as the incidence of hypotension. The use of anesthesia depth monitors used so far for children is controversial because brain development in children has not yet been completed and the calculation algorithms of these indices are based on adult EEG characteristics. There are very few studies in the literature on the relationship between anesthesia depth monitoring and EA/ED in children, and further studies are needed.

NCT ID: NCT05991453 Recruiting - Depression Clinical Trials

Trajectories of Recovery After Intravenous Propofol Versus Inhaled VolatilE Anesthesia Trial

THRIVE
Start date: September 13, 2023
Phase: N/A
Study type: Interventional

The investigators will conduct a 12,500-patient randomized multi-center trial to determine (i) which general anesthesia technique yields superior patient recovery experiences in any of three surgical categories ((a) major inpatient surgery, (b) minor inpatient surgery, (c) outpatient surgery) and (ii) whether TIVA confers no more than a small (0.2 %) increased risk of intraoperative awareness than INVA in patients undergoing both outpatient and inpatient surgeries

NCT ID: NCT05193747 Recruiting - Clinical trials for Anesthesia Awareness

The Depth of Paediatric Anaesthesia: Observational Trial

ANAPED
Start date: January 14, 2022
Phase:
Study type: Observational

Perioperative measurement of the Depth of anaesthesia is currently recommended part of daily anaesthesia good clinical practice. The optimal depth of anaesthesia measured by Bispectral index could be between 40-60. The lower (over 60) depth of anaesthesia could be associated with accidental intraoperative episodes of awareness and deeper (below 40) anaesthesia could lead to higher adverse events or even haemodynamic instability.

NCT ID: NCT04788732 Recruiting - Clinical trials for Anesthesia Awareness

Heart Rate Variability to Quantify General Anesthesia Depth

Start date: January 4, 2021
Phase:
Study type: Observational [Patient Registry]

The shortage of anesthetic agents can lead to intraoperative awareness while overdosing can trigger severe intra and postoperative problems. Therefore, monitoring anesthesia's depth (DoA: Depth of Anesthesia) is a crucial but still challenging task. Although some commercial monitors are based on electroencephalogram (EEG), designed to quantify DoA, their use in clinical practice has limitations. On the other hand, heart rate variability (HRV) has valuable information about physiological states, both from the heart and the organism. Classical indices derived from HRV have been shown to be able to differentiate the different stages of anesthesia. In this study, it is proposed to create a model to monitor DoA combining several HRV indices. Patients will be divided into three groups, according to the type of anesthesia to which they will be submitted (inhalation, total or balanced intravenous) and will have the electrocardiogram recorded during the entire surgical procedure. Various HRV indices will be calculated, and machine learning techniques will be used to combine and identify the most relevant index to compose a score that reliably represents DoA. Several commercial devices have been developed to monitor the level of consciousness during anesthesia. Among the most popular tools are included: Narcotrend TM (MonitorTechnik, Bad Bramstedt, Germany); the M-Entropy TM (GE Healthcare, Helsinki, Finland); Nindex SA (Controls, Montevideo, Uruguay) and the Bi-Spectral Index (BIS, TM Medtronic-Covidien, Dublin, Ireland). In this study, BIS or Nindex will also be monitored during the entire period that the patients remain anesthetized and will later be used to compose the DoA score based on HRV. As a result, a computer program will be created to monitor DoA in real-time.

NCT ID: NCT04009018 Recruiting - Clinical trials for Anesthesia Awareness

Adaptation of Perioperative Satisfaction Scale in Regional Anesthesia and Investigation of Its Psychometric Properties

Start date: June 20, 2019
Phase: N/A
Study type: Interventional

The aim of the study is to determine the psychometric properties of Perioperative Satisfaction Scale in Regional Anesthesia. In the Turkish version of the scale, a blind reverse translation method will use. And validity and reliability analyses will conduct.

NCT ID: NCT03773588 Recruiting - Clinical trials for Anesthesia Awareness

Entropy and Surgical Pleth Index Guided Closed Loop Target Controlled Infusion Total Intravenous Anesthesia With Propofol

Closedloop TCI
Start date: October 10, 2018
Phase: N/A
Study type: Interventional

Closed-loop infusion system for target controlled infusion of propofol by using TCI pump designed by BD Technology. (Germany) guided with entropy and surgical pleth index (GE) will not only prevent awareness from Anesthesia but also optimise the dose anesthetic agents based on feedback from adequacy of Anesthesia monitoring. Which not only reduces Anesthesia agents but also enhances recovery from Anesthesia. Innovation using TCI combined with closed-loop controlled intravenous anesthesia under the guide of Entropy.In this study we performed a randomized, controlled, study to compare closed-loop control and open-loop control of propofol by using the Entropy and SPI guided closed-loop infusion system.

NCT ID: NCT03476213 Recruiting - Clinical trials for Anesthesia Awareness

Manual Versus Targer-controll Infusion in Reduction of Awareness and Dreaming

Start date: March 16, 2018
Phase: N/A
Study type: Interventional

This study compares manual total intravenous anesthesia (TIVA) and target-controll infusion (TCI) in reduction of awareness and dreaming, and the haemodynamical stability during operation. Half of patients will be anesthetized using manual TIVA and other half using TCI.