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Intraoperative Awareness clinical trials

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NCT ID: NCT05254704 Not yet recruiting - Quality of Life Clinical Trials

Validation of the French Version of the TEX-Q Questionnaire.

TEX-Q-F
Start date: April 2022
Phase:
Study type: Observational

It is now known that the level of patients' expectations about a treatment (intervention, medication) can influence their prognosis. Positive expectations impact the effectiveness of the intervention, while negative expectations may lead to adverse events. It would therefore be useful to measure these expectations. However, there is no standardized questionnaire to report the overall level of expectation in the pre-operative phase. A team (led by Pr Meike C Shedden-Mora) has recently developed a questionnaire that aims to assess a patient's general level of expectation regarding a therapeutic intervention, taking into account the direct benefits and the expected adverse effects. This questionnaire, the brief version of the treatment expectation questionnaire (TEX-Q) is composed of 15 items. There's currently no French translation of the TEX-Q, nor has it been tested on a population scheduled for surgery. In addition to expectations regarding the surgical procedure, patients seem to have various expectations regarding the impact and specific role of anesthesia. Little literature exists on specific expectations regarding the role of anesthesia. Thus, we believe it is necessary to validate a French version of the TEX-Q questionnaire (TEX-Q-F) applied to the context of scheduled surgery, as well as to evaluate the specific expectations of anesthesia.

NCT ID: NCT05250882 Active, not recruiting - Clinical trials for Intraoperative Awareness

Enhanced Perioperative Care for the Prevention of Colorectal Anastomotic Leakage

DOUBLE CHECK
Start date: September 5, 2021
Phase: N/A
Study type: Interventional

This multicenter open-label trial is designed to evaluate if the implementation of an enhanced peri-operative care protocol results in an optimal intraoperative condition of the patient and in a decrease in incidence of anastomotic leakage after colorectal resection as compared to current practice.

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: NCT05032443 Completed - Nurse's Role Clinical Trials

Anesthesia Awareness in Pediatric Gastrointestinal Endoscopy Nurses

Start date: August 23, 2021
Phase:
Study type: Observational [Patient Registry]

Background and Aim: Pediatric gastrointestinal (GI) endoscopy is an increasingly common procedure performed to investigate and diagnose problems in the GI tract in children. Procedures in pediatric endoscopy units are routinely performed under sedation and general anesthesia, unlike adult endoscopy. Nurses working in pediatric gastroenoscopy units where sedoanalgesia is applied have important duties and responsibilities in terms of quality standards in preoperative, intraoperative and postoperative periods. Considering the increasing need for high-quality pediatric endoscopy applications, the attitudes and behaviors of nurses about sedation in pediatric patients are important as a member of the team. There is almost no literature on the experience and awareness of pediatric endoscopy nurses in clinical practice, and this encourages our team to conduct a survey across our country and to develop knowledge and clinical practices. With this questionnaire survey, it was aimed to evaluate the experience and attitudes of the endoscopy nurses working in the pediatric endoscopy unit in our country on sedation/general anesthesia management for pediatric patients

NCT ID: NCT05019560 Completed - Clinical trials for Awareness, Anesthesia

Awareness in Old Aged Patients During Laryngoscopy and Intubation Using Isolated Forearm Technique

Start date: September 5, 2021
Phase: Phase 4
Study type: Interventional

Awareness during general anesthesia - that has an incidence between 0.1% and 0.9% of cases and may be more in elderly - remains a concern for anesthesiologists. Awareness experiences range from isolated auditory perceptions to reports of a patient being fully awake, immobilized, and in pain. The isolated forearm technique allows assessment of consciousness of the external world (connected consciousness) through a verbal command to move the hand (of a tourniquet-isolated arm) during intended general anesthesia.

NCT ID: NCT04949815 Completed - Clinical trials for Arteriovenous Malformations

Awake Craniotomy for Arteriovenous Malformation

Start date: April 1, 2018
Phase:
Study type: Observational

The study aimed to retrospectively review cases of brain arteriovenous malformation that were surgical resected with the patient awake during the procedure.

NCT ID: NCT04826146 Active, not recruiting - Pain Clinical Trials

Pediatric Validation of CONOX Monitor During Surgery

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

Pediatric Validation of CONOX Monitoring device (qCON and qNOX indices) for anesthesia depth during surgery

NCT ID: NCT04813952 Completed - Clinical trials for Anesthesia; Functional

The Effect of Minimal Flow Sevoflurane Anesthesia

Start date: February 15, 2021
Phase: N/A
Study type: Interventional

Our aim is to investigate the effect of minimal flow anesthesia with sevoflurane on hemodynamics and arterial blood gas parameters in laparoscopic cholecystectomy operations.

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: NCT04747379 Recruiting - Depression Clinical Trials

Psychological Effect of Explicit Recall After Sedation (PEERS)

PEERS
Start date: September 16, 2021
Phase:
Study type: Observational

Awareness, or explicit recall, under sedation is often intended and expected by anesthesiologists and is assumed that does not associate with any sequelae. Thus, awareness under sedation is a common event and is estimated to occur in around one-quarter of patients in our population. However, two recent registry studies suggested some patients with awareness under sedation have comparable psychological sequelae to those patients with awareness during general anesthesia. As such, we plan to conduct a a single center, prospective cohort study to evaluate the incidence, experience and psychological consequence of awareness under sedation. In this study, we will prospectively include 2500 patients who will be scheduled to have major joint replacement surgery under regional anesthesia and sedation at University Hospital, London Health Sciences Center. All participants will be assessed at four separate time points including: 1. Enrollment/Surgical Preparatory Area (~ 2 hours before surgery) 2. Post Anesthesia Care Unit (or up to 6 hours after surgery) 3. Postoperative day one (in hospital) 4. Postoperative 3 months (expected to be after discharge via telephone)