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Orthopedic Surgery clinical trials

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NCT ID: NCT05298228 Recruiting - Orthopedic Surgery Clinical Trials

Dose Finding Study of Remimazolam for Laryngeal Mask Airway Insertion

Start date: March 2022
Phase: N/A
Study type: Interventional

Laryngeal mask airways (LMA) are widely used in patients receiving general anesthesia and are known to have the following advantages over the endotracheal tube: lower incidence of postoperative sore throat, lower incidence of cough during emergence, and lower incidence of postoperative vomiting. Although LMAs can be inserted without the use of muscle relaxants, a sufficient depth of anesthesia is necessary for placement. Remimazolam is a newer anesthetic that is ultra-short acting with a rapid onset and short context-sensitive half-life allowing for fast recovery. However, the dose of remimazolam needed for LMA insertion without muscle relaxants is not well known. This dose-finding study aims to find the ED50 and ED95 of a single bolus dose of remimazolam for LMA insertion without muscle relaxants in adult patients. This is an interventional study done in a single group using the Dixon's up-and-down method which requires at least six success/failure pairs in the same direction. The primary endpoint of this study is to investigate the dose of remimazolam associated with 50% (ED50) and 95% (ED95) probability for adequate depth of anesthesia for LMA insertion without muscle relaxants. The beginning dose of remimazolam is 0.3 mg/kg, and when LMA insertion is successful, the dose will be decreased by 0.05 mg/kg in the next patient. When LMA insertion is unsuccessful (failed), the dose will be increased by 0.05 mg/kg in the next patient. Successful LMA insertion is defined as symmetrical chest wall movement and square-wave capnographic traces observed with manual ventilation.

NCT ID: NCT05295199 Recruiting - Orthopedic Surgery Clinical Trials

The Effect of Progressive Relaxation Exercise on Fatigue and Comfort Level After Major Orthopedic Surgery

Start date: March 10, 2022
Phase: N/A
Study type: Interventional

This study was planned to determine the effect of progressive relaxation exercise to be applied after major orthopedic surgery on post-operative fatigue and comfort level.

NCT ID: NCT05286021 Recruiting - Orthopedic Surgery Clinical Trials

Comparison of the Clinical Performance and Safety of the Ambu®AuraGainTM Laryngeal Mask in Children Undergoing Surgery in the Supine and Prone Position - A Prospective, Noninferiority Clinical Trial

Start date: March 2022
Phase:
Study type: Observational

The Ambu Auragain is a 2nd generation laryngeal mask airway that is widely used in adult and pedicatric patients. While its use is generally recommended in patients undergoing surgery in the supine position, depending on patient characteristics, type of surgery and experience of the anesthesiologist, it may also be used in the lateral or prone position. There have been reports of LMA use in patients undergoing short procedures in the prone position, but its safety in pediatric patients is not clear. This study was designed to compare oropharyngeal leak pressure between children undergoing surgery in the supine and prone position using the Ambu Auragain LMA.

NCT ID: NCT05257278 Active, not recruiting - Orthopedic Surgery Clinical Trials

MonoPlus® in Orthopedic Surgery

UNITE
Start date: January 18, 2022
Phase:
Study type: Observational

Single-center postmarket clinical follow-up study (PMCF) on the performance and safety of MonoPlus® in patients undergoing orthopedic surgery

NCT ID: NCT05181163 Not yet recruiting - Orthopedic Surgery Clinical Trials

Biofilm Formation and Antibiotic Sensitivity Patterns

Start date: January 2022
Phase:
Study type: Observational

Detection of bacteria that form biofilm and its sensitivity to antibiotics in patients with surgical site infection after orthopedic surgery.

NCT ID: NCT05169281 Completed - Surgery Clinical Trials

Distribution of Medication Disposal Packets - Acute Opioid Prescribing

Start date: March 24, 2021
Phase: N/A
Study type: Interventional

Many prescription opioids following surgery are left unused and are at risk of being misused or diverted. Encouraging proper disposal is important, yet motivating this behavior remains challenging as patients must understand the risks of opioids, the benefits of disposal, and identify opportunities and places to dispose of them safely. Alternative disposal techniques can improve disposal rates but may be lost or forgotten. Applying behavioral economics techniques may lower the barriers and promote disposal. The objective is to test the effect of a specifically timed, mailed, at-home kit on disposal rates following surgery.

NCT ID: NCT05120739 Completed - Orthopedic Surgery Clinical Trials

Efficacy of CHX Cloths Versus CHX Soaps for Bathes Before Orthopedic Surgery

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

Surgical site infections (SSI) in orthopedic surgery are rare events but associated with great morbidity as well as a significant additional cost. The World Health Organization (WHO) recently carried out meta-analyzes on all the existing prophylactic measures and could not rule on the use of chlorhexidine (CHX) cloths due to the low number of studies available. CHX cloths could actually benefit patients for whom preoperative showering is not possible, whether in emergency or trauma settings due to pain-induced functional impotence. A randomized controlled clinical study aimed at evaluating the in vivo microbiological efficacy of CHX cloths in a population of orthopedic surgery patients while evaluating the psycho-social determinants of adherence to a new preoperative preparation technique seems essential.

NCT ID: NCT05110690 Completed - Depression Clinical Trials

Behavioral Activation and Medication Optimization for Perioperative Mental Health Feasibility Study

Start date: November 17, 2021
Phase: N/A
Study type: Interventional

Inadequate management of preoperative mental health disorders often contributes to poor postoperative outcomes, including increased rates of readmission, delirium, falls, and mortality. However, very little work has been done to improve perioperative mental health. In particular, there have been limited systematic efforts that identify evidence-based behavioral and pharmacological strategies that were originally developed for depression and anxiety in otherwise medically well psychiatric patients. A mental health intervention bundle, composed of behavioral and pharmacological strategies, can mitigate anxiety and depression symptoms during the perioperative period. However, lacking is conclusive evidence on effectiveness of such an intervention bundle focused on the delivery of perioperative mental health care in older surgical patients. Towards this end, the investigators will develop and test an intervention bundle that encompasses: (1) behavioral activation, and (2) medication optimization.

NCT ID: NCT04491656 Completed - Orthopedic Surgery Clinical Trials

Evaluating Clinical Outcomes for Determining the Optimal Delay to Skin Incision Under WALANT

WALANT
Start date: January 1, 2019
Phase: N/A
Study type: Interventional

Further studies are needed to establish the effects of WALANT in performing most common hand surgeries, in relation to its clinical outcomes and intraoperative blood loss. Therefore, this study aims to identify the best interval time to perform elective hand surgeries using WALANT technique, document clinical outcomes and identify potential complications

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).