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Sedation Complication clinical trials

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NCT ID: NCT06337877 Active, not recruiting - Clinical trials for Sedation Complication

Assessment of Sedation Depth in ARDS Patients Undergoing Therapeutic Paralysis

Start date: October 1, 2023
Phase:
Study type: Observational

"In intensive care units, therapeutic paralysis has been a routine treatment method for many years in a select group of patients. Sufficient and appropriate sedation in patients undergoing therapeutic paralysis is crucial to prevent awareness and reduce the risk of excessive sedation. Both inadequate and excessive sedation levels can be highly detrimental to the patient. Clinical assessment may not always provide accurate information regarding sedation depth. Recently, the frequency and workload of therapeutic paralysis treatment in intensive care units have increased due to COVID-19 pneumonia. Therefore, the investigators believe that inadequate sedation may be common in these patients. Processed electroencephalogram parameters such as bispectral index or patient state index (PSI), routinely used in operating rooms and intensive care units, are commonly used to indicate sedation depth. In this study, the investigators aimed to determine sedation levels in patients during paralysis, assess the prevalence of inadequate or excessive sedation, and observe the doses of sedatives and analgesics used."

NCT ID: NCT06270212 Recruiting - Clinical trials for Perioperative Complication

Medical Device for Airway Patency During Sedation

STAIRWAY-2
Start date: February 1, 2024
Phase: N/A
Study type: Interventional

OVERALL SYNOPSIS PART A: Systematic evaluation in spontaneously breathing healthy volunteer study participants - of cumulative duration of manual measures for airway patency and for mask ventilation with airway device prototype (STAIRWAY) vs. standard procedure (no device) during target-controlled induction of mild and moderate-to-deep sedation with propofol in the supine position - of minimum anteroposterior and lateral transpharyngeal distances at tongue-base and soft-palate levels, determined by magnetic resonance imaging (MRI) with STAIRWAY vs. biteblock or no device during no, mild and moderate-to-deep steady-state sedation with propofol in the supine position. PART B: Systematic evaluation (in the body position [normally supine] considered most optimal for the procedural intervention) of the cumulative duration - of adjuvant manual airway support and ventilation - of respiratory arrest (interrupted monitoring of endtidal carbon dioxide [ETCO2]) - of hypoxemia (hemoglobin saturation of oxygen [SpO2] <95 %), and - of perceived sedational comfort, of sedational and procedural usability, and of sedational and procedural preference with STAIRWAY vs. standard procedure (biteblock or no device) during PS according to SOC for scheduled diagnostic or therapeutic procedures planned to be carried out under PS with propofol in spontaneously breathing study patients.

NCT ID: NCT06225037 Recruiting - Anesthesia Clinical Trials

EEG-guided Propofol Sedation Versus Standard Care for Oesophagogastroduodenoscopy and Colonoscopy in Children

EPOC
Start date: December 15, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare electroencephalogram (EEG) guided propofol sedation versus standard care in paediatric patients aged 6-16 undergoing oesophagogastroduodenoscopy and colonoscopy. The main questions it aims to answer are whether EEG guided propofol sedation will result in: - faster wake up time - reduced time to discharge - reduced cumulative propofol dosage - lower incidence of intraoperative adverse events - no difference in intraoperative undesirable movement - lower incidence and severity of emergence delirium - lower intraoperative depth of sedation Participants will wear an EEG sensor (Sedline) prior to undergoing propofol sedation until they wake up post procedure.

NCT ID: NCT06174168 Completed - Elderly Patients Clinical Trials

The Decisiveness of MFI-11 in Predicting Complications in Patients > 65 Years Who Underwent EBUS-TBNA Under Sedation

Start date: October 1, 2023
Phase:
Study type: Observational [Patient Registry]

The aim is to evaluate the feasibility of MFI-11, one of the comprehensive frailty tests, before EBUS-TBNA. The secondary aim is to evaluate the usefulness of MFI-11 in predicting complications in risk assessment before EBUS-TBNA.

NCT ID: NCT06124027 Recruiting - Clinical trials for Sedation Complication

Impact of Sedation With HFNOT on tcPCO2, mitoPO2 and mitoVO2.

Start date: February 13, 2023
Phase:
Study type: Observational

Deep procedural sedation has seen an increased use indication over the last couple of years aided by the introduction of high flow nasal oxygen therapy (HFNOT) during these procedures. However, this level of deep sedation does come with the increased risk of examining whether a patient is adequately ventilated during this procedure. The definition of deep sedation is: 'a drug-induced depression of consciousness during which patients cannot be easily aroused but respond purposefully following repeated or painful stimulation. The ability to independently maintain ventilatory function may be impaired. Patients may require assistance in maintaining a patent airway, and spontaneous ventilation may be inadequate. Cardiovascular function is usually maintained.' As the definition showed there may be an insufficient ventilation during deep sedation. Therefore, HFNOT is used to ensures that the peripheral oxygen saturation is sufficient. However, there are two potential disadvantages. HFNOT can mask the presence of an insufficient respiratory minute volume and an insufficient gas exchange, which can lead to high arterial CO2 (paCO2) levels. Another risk associated with HFNOT is the fact that high oxygen levels are toxic, and prolonged exposure to high partial oxygen pressures, can cause oxidative damage to cell membranes, collapse of the alveoli in the lungs, retinal detachment, and seizures. Most of this damage can be explained by hyperoxia that increases the 'leak' of electrons from the mitochondrial electron transport chain and the resulting increased generation of reactive oxygen species (ROS). Low paCO2 levels and hyperoxia cannot be examined using standard monitoring techniques therefore, this study will use the transcutaneous carbon dioxide (tcPCO2) a proven technique which correlates well to the arterial CO2 (paCO2) to evaluate whether there is an adequate level of ventilation during deep procedural anesthesia with HFNOT. Moreover, the cutaneous mitochondrial oxygenation (mitoPO2) will be monitored to determine the effects that deep procedural sedation with HFNOT has on the cellular oxygenation.

NCT ID: NCT06060626 Recruiting - Clinical trials for Sedation Complication

Optimization of Sedation Protocol for Endoscopic Procedures Using Impedance Ventilation Monitor.

Start date: November 16, 2023
Phase: N/A
Study type: Interventional

The aim of the study is to evaluate the effect of opioids administered during sedation on patients' respiratory activity (ventilation) and comfort of the operator and patient during the endoscopic procedure. A common side effect of sedation is the effect on patients' ventilation, resulting from a combination of attenuation of respiratory centre activity and loss of patent airways. Shallow sedation will reduce these risks, but in addition to patient discomfort, it also increases the difficulty or impossibility of the endoscopist to perform the procedure. Choosing the appropriate method of sedation thus fundamentally affects the course of the procedure from the point of view of both the patient and the endoscopist. The aim is to prove that sedation with propofol alone compared to sedation with propofol and fentanyl premedication leads to the need for higher cumulative doses of administered propofol, higher risk of respiratory depression and lower patient and operator comfort. In addition, the non-invasive respiratory volume monitor (ExSpiron 2Xi) will be used for standard patient monitoring during the procedure, which assesses the lung tidal volume and respiratory rate by measuring the electrical impedance of the chest. This measurement captures inadequate ventilation before saturation drops, allowing even slight differences between selected drugs to be compared.

NCT ID: NCT06044298 Not yet recruiting - Frailty Clinical Trials

Advers Events in Patients Undergoing Gastrointestinal Procedural Sedation

Start date: January 2024
Phase:
Study type: Observational

Investigators will include in our study patients aged 60 and over who have been evaluated in the pre-anesthesia clinic for procedures such as endoscopy, colonoscopy, ERCP, PEG, EUS, and ESD, and who have received sedation by an anesthesiologist. Patients will be assessed for frailty prior to the procedure; during and after the procedure, respiratory monitoring (SpO2, capnography) will be closely observed, and they will be contacted by phone three days later. Primary goal of the study is to prospectively investigate the incidence of peri-procedural complications (desaturation, bradycardia, hypotension, etc.) in elderly patients undergoing gastrointestinal procedural sedation, and to assess its relationship with detected frailty using the FRAIL scale.Secondary goals of the study are to identify risk factors for adverse events, examine the relationship of these factors with 'ASA score - age and frailty scale', and determine their impact on the incidence of adverse events. Additionally, investigators aim to research the effects of capnography-based respiratory monitoring on adverse events.

NCT ID: NCT06033729 Completed - Lung Cancer Clinical Trials

Remifentanil Target Controlled Infusion Versus Standard of Care for Conscious Sedation During EBUS-TBNA

Start date: September 20, 2021
Phase: N/A
Study type: Interventional

Background: endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is a minimally invasive procedure for diagnosing and staging mediastinal lymph node lesions in lung cancer. Adequate sedation is crucial for patient comfort and diagnostic accuracy. Different sedation modalities, including moderate sedation/conscious sedation, deep sedation, and general anesthesia, are utilized. This study aims to evaluate patient comfort and satisfaction levels of healthcare providers (bronchoscopists and anesthesiologists) when administering remifentanil through Target Controlled Infusion (TCI) for conscious sedation during EBUS-TBNA. A prospective randomized study design compares this approach to the standard sedation protocol involving midazolam, fentanyl, and/or propofol. Methods: this study will enroll 30 eligible patients randomly divided into two groups. Group 1, "REMIFENTANIL TCI", underwent EBUS-TBNA under conscious sedation with remifentanil TCI infusion targeting a concentration of 3-6 ng/ml. Group 2, "STANDARD", received conscious sedation with a combination of midazolam, fentanyl, and/or propofol administered in boluses based on clinical requirements. Complications, safety, and satisfaction levels of the operator, anesthesiologist, and patients will be evaluated.

NCT ID: NCT06014138 Recruiting - Clinical trials for Acute Respiratory Distress Syndrome

Volatile Sedation for Patients With the Acute Respiratory Distress Syndrome

ISO-DRIVE
Start date: November 1, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

This study will investigate how different types of routine sedation may affect patient's breathing whilst on a ventilator in the Intensive Care Unit (ICU). There are different approaches to sedation which may have advantages and disadvantages. During the study patients will receive both intravenous and inhaled volatile sedation (similar to anaesthetic 'gases' used for general anaesthesia) and the drive to breath, breathing efforts and function of the lung will be assessed.

NCT ID: NCT05996588 Completed - Clinical trials for Sedation Complication

Comparison Between Sevoflurane and Propofol for Maintenance of Sedation During ERCP

Start date: January 5, 2022
Phase: Phase 4
Study type: Interventional

After approval of ethical committee of Sindh Institute of Urology & Transplantation (SIUT), 86 patients were enrolled for the elective endoscopic retrograde cholangiopancreatography (ERCP). Randomization was done by a computer-generated randomization table. Patients were divided in two groups based on agents used for the research study. Both the groups were induced by injection midazolam 0.06 mg/kg body weight and injection nalbuphine 0.1 mg/kg body weight. In group A, anesthesia was maintained by Sevoflurane inhalation via nasal prongs with oxygen to achieve minimum alveolar concentration (MAC) approximately 0.25%. Whereas, in Group B propofol infusion at 50 ug/Kg/min started for maintenance of anaesthesia. Ketamine 0.5mg/kg intravenously was used to rescue the sedation level in both groups