Fentanyl

Researchers are evaluating the safety, tolerability, pharmacokinetics, and efficacy of CS-1103 given by intravenous infusion in healthy adults aged 18 to 55. This study involves a fentanyl challenge combined with naloxone blockade to assess how CS-1103 interacts with these drugs. The study is a randomized, double-blind, placebo-controlled Phase 2 trial sponsored by Clear Scientific, Inc., focusing on fentanyl overdose and poisoning scenarios. Participants receive naloxone (400 mcg IV) first, followed by fentanyl (200 mcg IV), and then either CS-1103 (1,000 mg IV) or a placebo (saline) infusion. The trial compares the effects of CS-1103 against placebo under these controlled drug administration conditions. The study includes a single dose of the investigational drug administered intravenously after fentanyl and naloxone. During the study, participants are closely monitored for adverse events through physical exams, ECGs, vital signs, and laboratory tests over a period of three days plus a follow-up on Day 10. Blood and urine samples are collected for up to 48 hours to measure CS-1103 and fentanyl levels. The trial also evaluates the impact of CS-1103 on QT intervals and naloxone pharmacokinetics. Total participation lasts through these monitoring and follow-up periods to ensure safety and gather efficacy data.

Researchers are studying the effects of Huperzine A Injection on reducing postoperative delirium in elderly patients aged 75 and older who are undergoing non-cardiac surgery. This randomized, double-blinded, placebo-controlled trial aims to observe how this treatment may influence the occurrence of delirium after surgery in this older population. Participants will be randomly assigned to receive either Huperzine A Injection or a placebo of 0.9% Sodium Chloride Injection during their non-cardiac surgical procedure. The study includes patients with an anesthesia grade of III to IV and an estimated operation time of at least 2 hours. The treatments will be administered under controlled conditions to carefully assess their effects on postoperative delirium. During the study, participants will be monitored for delirium incidence within 7 days after surgery, with additional evaluations at 24, 48, and 72 hours post-operation. Researchers will also assess the type, severity, and duration of delirium, length of hospital stay, economic costs, complications, mortality rates, and cognitive function using the Mini-mental State Examination and EuroQol scale. Follow-up assessments will continue up to 2 months after surgery, with some evaluations occurring around 30 days after discharge.

Adolescent overdose deaths are a leading cause of death among youth aged 10 to 19 in the United States, with numbers continuing to rise. Researchers are evaluating a brief overdose prevention education intervention designed for youth in primary care settings. This pilot study aims to assess how feasible and acceptable this intervention is for both healthcare providers and young patients, addressing a gap as there are currently no recommended overdose prevention programs specifically for youth in healthcare. In this two-arm cluster randomized controlled trial, pediatric and family medicine providers are randomly assigned to either deliver the brief overdose prevention education or provide usual care. Providers in the intervention group receive a 45-minute training, conducted in person or via Zoom, which covers overdose prevention education, intervention delivery, practice, and fidelity checklist completion. The intervention includes informing youth about overdose risk factors, safety strategies, recognizing and responding to overdoses, and naloxone use, with naloxone kits offered to take home. Youth participants aged 13 to 26 scheduled for a comprehensive physical exam with participating providers complete assessments at baseline, 2 weeks, and 6 months. Researchers will measure the feasibility and acceptability of the intervention by providers and youth, as well as youth knowledge and skills related to overdose risk, recognition, and response. The study excludes youth unable to consent or with cognitive limitations or acute medical/psychiatric distress. Participation is tracked over six months to evaluate the intervention's impact and acceptability.

Researchers are evaluating a new AI-assisted co-pilot system called SEASCAPE to improve pain management during general anesthesia. This system uses machine learning to monitor and control nociception—the nervous system's response to pain—by analyzing real-time physiological data from multiple monitors. The goal is to optimize the dosing of intravenous opioids like remifentanil to reduce both over- and under-dosing, potentially improving patient outcomes and reducing opioid-related complications during surgery. The study involves patients scheduled for elective surgeries requiring general anesthesia, where standard analgesia is provided by continuous remifentanil infusion controlled by a pharmacokinetic/pharmacodynamic model. SEASCAPE integrates this existing model with real-time data from monitors tracking hemodynamics, EEG, neuromuscular relaxation, and analgesia indices to provide personalized dosing recommendations. The project is conducted in three phases: initial data collection from 30 patients, expanded data collection from 100 patients under different anesthetic techniques, and usability assessment involving 20 anesthesiologists using the system in pilot mode. Participants will undergo general anesthesia with standard care while data is collected from multiple devices connected via a digital platform. The system will classify nociception levels and suggest adjustments to opioid dosing without altering usual clinical decisions. Researchers will analyze physiological patterns, anesthetic depth, muscle relaxation, and clinician feedback to assess the system's accuracy and usability. The entire process spans from the start to the end of anesthesia, aiming to refine intraoperative pain control and improve postoperative outcomes.

Researchers are evaluating the effects of four different anesthetic maintenance methods on surgical conditions, blood pressure stability, and brain protection during functional endoscopic sinus surgery (FESS) performed with controlled low blood pressure. The study compares propofol-remifentanil alone, propofol-remifentanil with added ketamine and magnesium, sevoflurane-remifentanil alone, and sevoflurane-remifentanil with added ketamine and magnesium. The main focus is on measuring blood markers of brain injury and assessing the quality of the surgical field and bleeding during surgery. Participants are randomly assigned to one of the four groups receiving general anesthesia with either propofol-remifentanil or sevoflurane-remifentanil, with or without continuous infusions of ketamine and magnesium. The infusions are administered continuously during surgery according to the assigned group. This trial is conducted at a single center and includes a triple-blind design to reduce bias. During the study, participants will have blood samples taken at three key times: before surgery starts, 20 minutes after controlled low blood pressure begins, and at surgery end to measure brain injury markers. Surgeons will rate surgical field visibility and bleeding at the end of surgery. Recovery will be assessed immediately after extubation using standard scores, and postoperative pain will be measured within 24 hours. The total participation involves the surgery and immediate postoperative period, with ongoing monitoring of outcomes related to anesthesia methods and brain protection.

Researchers are evaluating the pain relief effects and safety of three drugs—oliceridine, morphine, and sufentanil—in patients undergoing elective lumbar spine surgery. This randomized controlled trial aims to compare these medications when used for postoperative pain control, focusing on how well they reduce pain during movement six hours after surgery. The study also examines side effects such as nausea, vomiting, sleepiness, breathing problems, and itching within the first 48 hours after surgery. Participants are randomly assigned to one of three groups to receive intravenous patient-controlled analgesia after their surgery. The oliceridine group receives a 1.5 mg loading dose followed by a continuous infusion of 0.01 mg per kilogram per hour. The morphine group receives a 4 mg loading dose followed by an infusion of 0.03 mg per kilogram per hour. The sufentanil group receives a 4 microgram loading dose followed by an infusion of 0.03 micrograms per kilogram per hour. Each infusion is diluted in 100 ml of saline and delivered at a rate of 2 ml per hour. During the study, participants' pain levels are assessed using a Visual Analogue Scale both at rest and during movement at multiple time points up to 48 hours after surgery. Researchers also monitor sedation levels, the number of times patients use the pain control button, the need for extra pain medication, and vital signs shortly after the initial dose. The study lasts through the first 48 hours after surgery, focusing on both pain relief and safety outcomes to better understand how these medications compare.

Researchers are evaluating sedation protocols for adults undergoing cataract surgery to find the best approach for patient comfort and safety. This study compares the effects of three sedation methods: dexmedetomidine combined with fentanyl, propofol combined with fentanyl, and a combination of dexmedetomidine, propofol, and fentanyl. The goal is to understand how these protocols impact sedation levels, heart rate, blood pressure, respiratory events, surgeon satisfaction, and side effects like bradycardia, hypotension, and nausea. Participants will be randomly assigned to one of three groups receiving different sedation treatments. The dexmedetomidine groups receive a loading dose followed by maintenance infusion, propofol is given via target-controlled infusion to reach a specific sedation level, and all groups receive a single bolus of fentanyl. Three anesthesiologists will administer the protocols during elective cataract surgery on one or both eyes, with monitoring throughout the procedure and recovery. During the study, trained anesthesiologists and nurse anesthetists will assess sedation using the Ramsay sedation scale during surgery and in recovery. Participants will be closely monitored for vital signs and adverse effects. Surgeons will share their satisfaction with the sedation. The main outcomes measured are sedation levels during surgery and recovery, tracked over approximately one year. Safety and comfort will be carefully observed throughout the study period.

Researchers are evaluating the effects of the timing of bilateral maxillary nerve block administration on intraoperative remifentanil use and postoperative pain control in patients undergoing septorhinoplasty surgery. This regional anesthetic technique targets the maxillary nerve to provide pain relief during and after midfacial and maxillary surgeries. The study compares administering the block after intubation versus before extubation to assess impacts on opioid consumption and pain management. Participants will be randomly assigned to receive the maxillary nerve block either after intubation or before extubation. The block is performed under ultrasound guidance using an infrazygomatic approach to access the pterygopalatine fossa. Each side receives 4 mL of a local anesthetic solution consisting of 2 mL of 0.5% bupivacaine and 2 mL of 2% lidocaine. The procedure involves visualization of anatomical landmarks and careful injection to ensure proper delivery. During the study, researchers will monitor intraoperative remifentanil consumption, mean arterial pressure, heart rate, and postoperative pain scores within the first 24 hours after surgery. The block procedure preparation includes aseptic techniques and the use of ultrasound imaging. Participation involves standard surgical care with added nerve block administration and close monitoring of vital signs and pain levels to evaluate the effects of the timing of the block.

Researchers are evaluating the effects of an emergency department community health worker-peer recovery specialist program called the Substance Misuse Assistance Response Team (SMART) on people with substance use disorders. This observational, prospective case-control study aims to understand participant experiences with SMART, evaluate its effectiveness on recovery outcomes and linkage to treatment, and assess program implementation over time. The study focuses on improving recovery service connections for patients after substance use-related emergency visits, a critical time when the risk of death is elevated. The study compares two groups: patients who receive SMART services and those who do not. SMART provides personalized support, short-term case management, and navigation to social services, harm reduction, recovery, and addiction treatment both inside and outside the emergency department. Services include assistance with buprenorphine initiation, behavioral counseling, and help accessing housing, transportation, and other social resources. Patients not receiving SMART services receive usual care with referral at the emergency department team's discretion. Participants will complete surveys at enrollment, and again at 3 and 6 months after their initial emergency visit. Researchers will link survey data with state administrative databases to measure outcomes such as addiction treatment engagement, recovery capital, social services use, acute care visits, repeat hospitalizations and overdoses, mortality, employment changes, and criminal justice encounters. The study will provide important information about how SMART impacts patient outcomes and program delivery, with follow-up through October 2026.

Researchers are evaluating the safety and feasibility of using a balanced 1:1 ratio of tetrahydrocannabinol (THC) and cannabidiol (CBD) cannabis oil as an additional therapy to methadone-based opioid agonist therapy (OAT) for individuals with opioid use disorder (OUD). This pilot study is conducted in a community setting and involves adults diagnosed with OUD who have recently started or restarted methadone treatment. The trial is designed as a Phase II, placebo-controlled, double-blind study to assess these treatments over a 12-week period. The study has two phases. In Phase 1, 24 participants are randomly assigned to receive either the THC:CBD cannabis oil or a placebo oil alongside their methadone therapy. The cannabis oil or placebo is self-administered sublingually with an initial dose of 5 mg per day, which can be adjusted with medical guidance up to a maximum of 40 mg per day. After completing Phase 1, eligible participants may join Phase 2, a 12-week open-label extension where all receive the THC:CBD cannabis oil. Research visits occur every two weeks during this extension. Participants will be involved in regular assessments including safety monitoring, adherence to treatment, and acceptability of the cannabis oil. Researchers will track treatment-emergent adverse events, the risk of treatment contamination, dose adequacy, and blinding effectiveness over 24 to 28 weeks. Other measures include enrollment rates, screening failure rates, and visit completion. The full study duration covers screening, two treatment phases, and follow-up visits to ensure thorough evaluation of the therapy combination.