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Orthopedic Surgery clinical trials

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NCT ID: NCT04335968 Recruiting - Orthopedic Surgery Clinical Trials

Melatonin for Prevention of Postoperative Delirium After Lower Limb Fracture Surgery in Elderly Patients

DELIRLESS
Start date: January 23, 2021
Phase: Phase 3
Study type: Interventional

Postoperative delirium (POD) is one of the most frequent complications after surgery in elderly patients, affecting between 20 and 40% of patients older than 60 after major surgery. This complication has huge consequences for the patients, families and society: increase of morbidity and mortality, prolonged length of stay, cognitive and functional decline leading to loss of autonomy, and important additional healthcare costs. Among numerous risk factors identified, perioperative inflammatory stress is a key element in delirium genesis: surgical trauma releases danger signals in systemic circulation, activating immune cells and leading to neuroinflammation. Melatonin is a neurohormone regulating circadian rhythm. But it also exhibits antioxidant and free radical scavenger properties, and regulates energy metabolism and immune function. It has already demonstrated a neuroprotective potential in various animal models. Its use against delirium is promising: it decreases delirium incidence in elderly patients hospitalized in medical ward, and several studies are now recruiting in ICU. The hypothesis of the trial is that in a high-risk population, perioperative melatonin can reduce the incidence of POD. The main objective is to evaluate the effect of perioperative melatonin administration on postoperative delirium incidence in the first 10 days after surgery, in elderly patients (over 70 years old) being hospitalized and scheduled for acute surgery of fractured lower limb (from femoral head to tibial plateau). This is a prospective, national multicentric (24 centers), phase III, superiority, comparative randomized (1:1) double-blinded clinical trial with two parallel arms: Experimental group: melatonin 4mg per os every night, starting the evening before surgery (or 2 hours before emergency surgery) and until day 5 after surgery. Control group: placebo of this drug with the same schedule, during the same period of time. The patients are aged 70 or older, hospitalized and scheduled for surgery of a severe fracture of a lower limb (from femoral head to tibial plateau).

NCT ID: NCT04288869 Recruiting - Orthopedic Surgery Clinical Trials

Change in Brain Perfusion During Induction of General Anesthesia

CERVO2
Start date: January 27, 2021
Phase:
Study type: Observational

Arterial hypotension during general anesthesia remains a factor of poor outcomes, increases the risk of myocardial infarction, acute kidney injury and 1-year mortality. Furthermore, arterial hypotension may also decrease cerebral perfusion contributing to worsen neurological outcome. It seems necessary to monitor cerebral perfusion during anesthesia and to define individual dynamic targets of blood pressure. The goal of this study is to evaluate cerebral perfusion change in adult patients with or without cardiovascular risk factors during a standardized propofol-remifentanil anesthesia induction. Cerebral perfusion will be evaluated and compared by simultaneous measurements of cerebral blood flow, cerebral oxygen saturation and neurological function with use of transcranial Doppler (TCD), Near infrared spectroscopy (NIRS) and the Bispectral index (BIS) monitoring, respectively. Those measurements will be also repeated during and after treatment of arterial hypotension episodes in both groups.

NCT ID: NCT02737137 Recruiting - Orthopedic Surgery Clinical Trials

Dynamic Multimodal Monitoring for Ultrasound Guided Peripheral Nerve Blockade

Start date: January 2016
Phase: N/A
Study type: Interventional

In clinical practice, local anesthetic injection pressure monitoring is performed manually or by a pressure transducer according to the availability of the equipment or preferences of clinicians. To date, no comparative study has measured the advantages of this measure during PNB. The aim of this study is to evaluate injection pressure monitoring in order to reduce the risk of intraneural injection during peripheral nerve blocks

NCT ID: NCT01205295 Recruiting - Anxiety Clinical Trials

Patient Anxiety and Concern as Predictors for the Perceived Quality and Efficacy of Treatment

Start date: September 2010
Phase: N/A
Study type: Observational

Background: Previous studies have shown that anxiety and dissatisfaction with patient progress are predictors for increased postoperative pain and reduced impact and efficacy of pain treatment. However, it remains to be shown whether patient anxiety and concern are predictors for the perceived quality of patient progress and the perceived efficacy of treatment. The aim of this study is to investigate whether there is a correlation between preoperative anxiety and concern, and the perceived quality and efficacy of postoperative treatment. The hypothesis is that anxious and concerned patients are less satisfied with treatment and have a poorer response of their treatment. Methods/design: This PhD-project consists of four coherent studies. 1) A methodological study evaluating the CMD-SQ (Common Mental Disorder - Screening Questionnaire) questionnaire by a test-retest study. 2) The main study, a prospective follow-up study, has the aim of investigating the correlation between patient anxiety and concern, their perceived quality of patient progress and the perceived efficacy of treatment. This correlation will be detected by means of five questionnaires: CMD-SQ, EQ-5D, SF-12, HVOK, OHS or OSS. 3) A study consisting of an explicit internal medical audit with the aim to investigate whether the medical assessment of patient efficacy of treatment is consistent with their own self-reported efficacy of treatment. 4) An intervention study designed as a randomized clinical trial. The aim is to investigate whether a targeted effort towards patients with a high score of CMD-SQ, i.e. patients with anxiety and concern, can increase their self-reported efficacies of treatment and their perceived quality of progress. A total of 800 hip- and shoulder-patients will be included. Discussion: If a correlation between patient anxiety and concern, their perceived quality of progress and the perceived efficacy of treatment is found, it will be relevant to screen all hip- and shoulder-patients for anxiety and concern preoperatively and deal with this before their operation. This study will provide a proposition of how these patients can be taken care of through cognitive behavioural therapy as a targeted effort towards their anxiety and concern. Aim and hypothesis: The aim of this study is to investigate whether there is a correlation between patient anxiety and concern, and their perceived quality and efficacy of treatment. The overall hypothesis is that patients who are anxious and concerned are less satisfied with their treatment and have a poorer overall efficacy of their treatment.

NCT ID: NCT01050738 Recruiting - Clinical trials for Rheumatoid Arthritis

Local Analgesia in Knee- and Hipatroplastic Surgery in Patients With Rheumatic Disease: Extra- vs. Intracapsulare Position of Catheter

Start date: January 2010
Phase: N/A
Study type: Interventional

Postoperative pain is part of surgery trauma. In orthopedic surgery artroplastic replacement of knee- and hipjoints are common. Postoperative pain relieve can be complicated. A new concept for pain relieve postoperative is local infiltration analgesia (LIA). This technique implicates that a catheter is left in the surgical area and that local anestesia can be administered post surgery. The goal is no or only little pain with minimal side effects. The catheter could be placed intra- or extracapsulare. The best position is not known. Primary aim is to study if position of the catheter effects the need of other postoperative analgesia. Secondary aim is to study if the position effects patient mobility within the first two days.