Clinical Research Directory

Intranasal Dexmedetomidine-esketamine Administration and Postoperative Pain in Pediatric Patients

Postoperative pain after adenoid and tonsil surgery is significant, with approximately 75% of pediatric patients experiencing severe postoperative pain. Currently, there is a lack of clinical strategies to safely and effectively manage postoperative pain in children undergoing adenoid and tonsil surgery. Dexmedetomidine and esketamine can achieve appropriate sedation levels and alleviate postoperative pain when used in children. Both drugs can be administered intranasally, and their pharmacological effects complement each other, reducing side effects. This study aims to investigate whether intranasal administration of dexmedetomidine-esketamine combination can improve postoperative analgesia in children undergoing adenoid and tonsil surgery.

The Efficacy and Safety of Short Term S-ketamine Infusion as an Adjunctive Therapy in Patients With Fibromyalgia

Fibromyalgia is a chronic pain syndrome where current medications have limited efficacy and a slow onset of action. Esketamine shows potential as a rapid-acting analgesic, but previous low-dose studies failed to demonstrate long-term benefits. The efficacy of higher-dose ESK as an adjunctive therapy when standard treatments are insufficient remains unclear.

Subanesthetic Esketamine in Modified ECT for Severe Depression in Adolescents: Clinical and Mechanistic Study

The study design was a randomized, double blind, parallel controlled trial.The goal of this clinical trial is to learn if esketamine-assisted modified electroconvulsive therapy (ESK-MECT) works to treat severe depression in adolescents. It will also learn about the safety of ESK-MECT. The sample size was calculated based on the response rate of patients with depression undergoing electroconvulsive therapy(ECT).According to the results of the pilot study,the efficacy rate of subjects receiving adjunctive esketamine was approximately 78%,while the efficacy rate of those receiving only propofol was 63%.The expected superiority difference in remission rates between the two groups was 15%(one-sided)for the power calculation.Assuming a significance level of α=0.05 and a test power of β=0.2,with a 1:1 ratio of sample sizes between the two groups,the total sample size was calculated to be 198 using the PASS software(PASS 2023).Considering a dropout rate of 10%,a total of 220 subjects were required,with 110 subjects in each group. 1. experimental group The patients were given intravenous injection of 0.25 mg / kg esketamine, 1.5 mg / kg propofol and 1 mg / kg succinylcholine in turn. After anesthesia, the patients were given electroconvulsive therapy. 2. In the control group The patients were given normal saline consistent with esketamine injection volume, 1.5mg/kg of propofol and 1mg / kg of succinylcholine. After anesthesia, the patients were given electroconvulsive therapy. Efficacy evaluation 1. Main efficacy indicators Response rate of depressive symptoms after MECT treatment Response is defined as two consecutive HAMD-24 scores ≤ 50% before treatment after receiving MECT treatment. The response rate is calculated as the number of patients who achieved as response divided by the total number of patients receiving MECT.In this study, the 24-item version of HAMD was utilized. Participants will: Be randomly assigned to the esketamine group or the control group, and receive standard MECT treatment. Have seizure parameters, seizure duration, vital signs, and complications recorded. Complete psychiatric scale assessments, including HAMD-24, BSS, PANSS, WMS-RC and MoCA. Be assessed at the following time points: HAMD-24 and BSS after each treatment; PANSS after each treatment course;WMS-RC and MoCA before MECT and after one treatment course. All subjects did not discontinue antidepressants before modified electroconvulsive therapy(MECT),and they were fasting for 8 hours and no fluids for 2 hours.Three minutes before MECT,continuous qCON monitoring(Apollo-9000A,Chongqing Xideer Medical Equipment Co.,Ltd.,China)was initiated,while monitoring blood pressure,heart rate,and peripheral capillary oxygen saturation.Preoxygenation was administered for 3 minutes.The qCON monitor uses three electrodes on the forehead to collect raw electroencephalogram(EEG)signals.The qCON monitoring includes the qCON index,qNOX index,burst suppression(BS),and signal quality index(SQI).

Impact of Perioperative Dexmedetomidine and Esketamine on Postoperative Quality of Recovery

For patients after surgery, quality of recovery has significant impacts on the prognosis, quality of life, and rational allocation of medical resources. Dexmedetomidine and esketamine have each been used during the perioperative period and improved postoperative analgesia and subjective sleep quality. This 2x2 factorial trial is designed to explore the effects of dexmedetomidine, esketamine, and their combination on the quality of recovery in patients recovering from surgery under general anesthesia.

Determination of ED50 and ED95 With Clinical Efficacy of Intranasal Dexmedetomidine Combined With Esketamine for Preoperative Sedation in Pediatric General Anesthesia

For pediatric patients undergoing general anesthesia, poor anesthesia induction compliance often has adverse effects on individual behavior in the early postoperative period. Dexmedetomidine can reduce the cardiovascular responses and postoperative mental adverse reactions caused by esketamine anesthesia induction \[6\]. This study aims to explore the ED50 and ED95 and clinical effects of the combination of dexmedetomidine and esketamine nasal drops for preoperative sedation in children of different ages undergoing general anesthesia, providing a theoretical basis for the combined use of dexmedetomidine and esketamine for preoperative sedation in children undergoing general anesthesia.

Sedation With Dexmedetomidine-esketamine Combination and Delirium in ICU Patients

Patients in the intensive care unit (ICU) often develop anxiety and agitation, sleep disturbances, and delirium. Delirium occurrence is associated with worse early and long-term outcomes. Dexmedetomidine and ketamine are recommended for sedation and analgesia in postoperative ICU patients, but each may induce side effects. The sedative effects of dexmedetomidine can help mitigate the neuropsychiatric side effects of esketamine. Recent studies showed that dexmedetomidine-esketamine combination improved analgesia and sleep quality without increasing side effects. This trial is designed to test the hypothesis that dexmedetomidine-esketamine combination for sedation and analgesia in postoperative ICU patients may reduce delirium.

Dexmedetomidine-esketamine-ropivacaine Versus Sufentanil-ropivacaine for Epidural Labor Analgesia

Sufentanil-ropivacaine combination is commonly used for epidural labor anesthesia, but is associated with some adverse events. Dexmedetomidine and esketamine, each has been effectively used for neuraxial anesthesia in combination with local anesthetics. Plenty of evidences show that both dexmedetomidine and esketamine, combined with ropivacaine, are also effective as the sufentanil-ropivacaine combination when used for epidural labor analgesia. This pilot trial is designed to evaluate the efficacy and safety of the dexmedetomidine-esketamine-ropivacaine versus sufentanil-ropivacaine combination for epidural labor analgesia, and to test the feasibility of a future large randomized trial.

Effect of Dexmedetomidine and Esketamine on Catheter-related Bladder Discomfort

Catheter-related bladder discomfort (CRBD) is common in patients awaking from general anesthesia with an urinary catheter. We suppose that that use of dexmedetomidine and/or esketamine during anesthesia may reduce the occurrence of CRBD. This 2x2 factorial randomized trial is designed to explore the effects of esketamine, dexmedetomidine, and their combination on the occurrence CRBD in patients undergoing transurethral urological surgery.

Different Dose Esketamine and Dexmedetomidine Combination for Supplemental Analgesia After Scoliosis Correction Surgery

Scoliosis correction surgery is associated with severe pain. Patients after scoliosis correction surgery usually require high dose opioids and long duration analgesia, which may increase side effects and drug tolerance. In a recent trial, mini-dose esketamine and dexmedetomidine combination as a supplement to sufentanil significantly improved analgesia and subjective sleep quality after spinal correction surgery without increasing adverse events; however, the proportion of patients with moderate-to-severe pain remained high. The authors speculate that increasing esketamine dose in the combination may further improve analgesic effects.

Dexmedetomidine-Esketamine Combination for Sedation and Analgesia in ICU Patients

Patients with mechanical ventilation in the intensive care unit (ICU) often develop anxiety and agitation, sleep distuebances, and delirium. Delirium occurrence is associated with worse early and long-term outcomes. Dexmedetomidine and ketamine are recommended for sedation and analgesia in ICU patients, but each may induce side effects. The sedative effects of dexmedetomidine can help mitigate the psychiatric side effects of esketamine. Recent studies showed that dexmedetomidine-esketamine combination improved analgesia and sleep quality without increasing psychiatric side effects. This trial is designed to test the hypothesis that dexmedetomidine-esketamine combination for sedation and analgesia in ICU patients with mechanical ventilation may reduce delirium and improve respiratory recovery.

Mini-dose Dexmedetomidine-Esketamine Infusion and Perioperative Sleep Quality

Sleep disturbances are prevalent in older patients with osteoarthrosis or fracture who are scheduled for knee or hip replacement surgery. The occurrence of sleep disturbances is associated with worse outcomes including increased risk of delirium and cardiac events, and worsened functional recovery. Dexmedetomidine is a highly selective α2-adrenergic agonist with sedative, anxiolytic, and analgesic properties. It exerts sedative effects via activating the endogenous sleep pathways and produces a state like non-rapid eye movement sleep, which is different from opioid- and benzodiazepine-induced sedation. Esketamine is a N-methyl-D-aspartic acid receptor antagonist and has been used as an anesthetic and analgesic. Recent studies showed that low-dose esketamine has anti-depressive and sleep-promoting effects. The investigators suppose that mini-dose dexmedetomidine-esketamine combined infusion at night can improve perioperative sleep quality in patients scheduled for knee or hip replacement surgery.

Different Dose Esketamine and Dexmedetomidine for Supplemental Analgesia and Longterm Outcomes

Chronic postsurgical pain (CPSP) refers to pain that occurs or increases after surgery and lasts longer than 3 months. Severe acute postoperative pain is one of the major risk factors of CPSP. Spinal correction surgery is associated with severe pain due to large trauma and long duration. Ketamine and esketamine are N-methyl-D-aspartate receptor antagonists; they have antihyperalgesic effects and may reduce CPSP. Dexmedetomidine is an alpha 2-adrenoceptor agonist with sedative, anxiolytic, and analgesic effect; it is frequently used as an adjuvant to postoperative analgesia. In a previous trial of 200 patients after scoliosis correction surgery, mini-dose esketamine-dexmedetomidine in combination with opioids significantly improved analgesia and sleep quality but did not reduce CPSP. The authors speculate that increasing esketamine dose in the combination may further improve analgesia and, therefore, reduce the occurrence of CPSP.

Immunoinflammatory Regulation of Esketamine in Septic Patients

Studies have shown that excessive systemic inflammatory response and concomitant immunosuppression are the main cause of early death in patients with sepsis. Therefore, it is very important to reduce excessive inflammation and improve immunosuppression in the acute phase of sepsis. Clinical studies have shown that esketamine combined with propofol for sedation has been proven to be safe and effective for septic patients in the ICU due to its cardiovascular stability. Previous studies have demonstrated that esketamine has anti-inflammatory effects against depression and surgical stress. Our preliminary experimental studies have found that esketamine had strong anti-inflammatory effects in the acute phase of sepsis. However, it is not clear whether esketamine could reduce excessive inflammation and improve immunosuppression in septic patients primarily sedated with a continuous infusion of propofol. This intervention study is to investigate whether three consecutive days of intravenous esketamine infusions via infusion pump (0.07 mg/kg/h) could reduce excessive inflammation and improve immunosuppression in septic patients requiring mechanical ventilation in the ICU under sedation primarily with propofol.

Etomidate and Esketamine on Postoperative Pain After Tonsillectomy Undergoing Children

Objective: To explore the effect of etomidate and esketamine on postoperative pain after tonsillectomy in children. Methods: Investigators enrolled 64 children with American Society of Anesthesiologists (ASA) physical status I and II, aged 2-10 years, and scheduled for elective undergoing tonsillectomy with general anesthesia. All the enrolled patients were randomly divided into etomidate and fentanyl group (Group A) and etomidate and esketamine group (Group B). In the etomidate-fentanyl group (group A), 0.3 mg/kg etomidate and 4 µg/kg fentanyl were given at the induction of anesthesia, followed by continuous infusion of propofol at 4-12 mg/kg/h and remifentanil at 3-6 µg/kg/h until the end of the surgery, respectively; in the etomidate-esketamine group (group B), induction of anesthesia with 0.3 mg/kg etomidate and 0.5 mg/kg esketamine , followed by continuous infusion of propofol at 4-12 mg/kg/h and remifentanil at 3-6 µg/kg/h until the end of the operation. Anesthesiologists who were unaware of the grouping recorded the FlACC Pain Scale at 2 h, 8 h, and 24 h after surgery.

Application of Remimazolam, Dexmedetomidine, and Esketamine in Pediatric Preoperative Sedation

By comparing the application effects of three drugs in pediatric preoperative sedation, this study explores the optimal medication regimen, aiming to provide safer, more effective, and more personalized medication options for pediatric preoperative sedation. Additionally, this research will also focus on the impact of these three drugs on postoperative agitation in children, offering valuable references for the overall management of pediatric surgical anesthesia.

Effect of Low-dose EsketaMine on dElirium in High-risk Elderly Patients uNdergoing elecTive Surgery (ELEMENT)

Delirium is an acutely occurred neurocognitive disorder characterized by fluctuating symptoms of inattention, altered consciousness and cognitive dysfunction. Delirium is reported to occur in 4% to 65% of postoperative patients depending on the population, and is especially common in older patients. Postoperative delirium is disturbing to patients and their families, and it is a strong predictor of both early and long-term worse outcomes including increased non-delirium complications, increased perioperative mortality, shortened overall survival, declined cognitive function, and lowered quality of life. Although ketamine/esketamine has anti-inflammatory and neuroprotective effects, evidence on its efficacy in reducing postoperative delirium remains inconsistent and inconclusive. Existing studies are limited by heterogeneity, small sample sizes, single-center designs, and a focus on specific type of surgery. Research on elderly high-risk patients is lacking, and most studies administer the drug intraoperatively, with limited exploration of postoperative use. The optimal dosing and timing for POD prevention are unclear. This study aims to carry out a multicenter, single-blind, placebo-controlled, large-sample randomized controlled trial assessing the effect of low-dose esketamine, given intraoperatively and postoperatively, on delirium in elderly high-risk patients undergoing major non-cardiac surgery.

Dexmedetomidine-Esketamine Combination and Sleep Disturbances After Major Noncardiac Surgery

Sleep disturbances are common early after major surgery, and are associated with delayed recovery. A previous study showed that dexmedetomidine-esketamine combination as a supplement to patient-controlled intravenous analgesia improved postoperative analgesia and subjective sleep quality in patients after scoliosis correction surgery. The purpose of this trial is to test the hypothesis that dexmedetomidine-esketamine combination used as a supplement during general anesthesia and postoperative intravenous analgesia may reduce sleep disturbances in adult after major noncardiac surgery.

Effects of Esketamine on Oxygenation and Quality of Recovery in Patients Undergoing Thoracoscopic Surgery

A total of 126 patients undergoing elective thoracoscopic surgery under general anesthesia were randomly divided into three groups: normal saline group (Group C), dexmedetomidine group (Group D), and esketamine group (Group E),with 42 patients in each group.In Group C,an equal volume of normal saline was continuously infused. In Group D,a loading dose of dexmedetomidine (1 μg/kg) was administered 10 min before induction of anesthesia, followed by a continuous infusion at a rate of 0.4 μg·kg-1·h-1 until 30 minutes before the end of the surgery. In Group E, 0.2mg/kg esketamine was infused intravenously before the induction of anesthesia for 10 min, and then maintained at 0.15 mg·kg-1·h-1 until 30 minutes before the end of the surgery. The primary outcome measures of this study were the oxygenation index (OI) at the following time points: before one-lung ventilation (OLV) (T1), 30 minutes after OLV initiation (T2), and 60 minutes after OLV initiation (T3). The secondary outcome measures included: (1)The duration of OLV, blood loss, fluid infusion volume, the dosages of propofol, remifentanil and vasoactive drugs(ephedrine and atropine) were recorded in each group.(2)Heart rate (HR) and mean arterial pressure (MAP) were recorded at the following time points: upon entering the operating room (T0), before OLV (T1), 30 minutes after OLV initiation (T2), 60 minutes after OLV initiation (T3), before extubation (T4), and 5 minutes after extubation (T5).(3)Blood gas anlaysis parameters,airway plateau pressure,tidal volume and positive end-expiratory pressure were recorded from T1 to T3，and dynamic lung compliance and intrapulmonary shunt fraction were calculated.(4) White blood cell counts, neutrophil percentage,and C-reactive protein (CRP) levels were recorded preoperatively and 24 hours postoperatively.(5)Postoperative pain was evaluated using the visual analogue score (VAS) at 2, 6, 12, and 24 hours after surgery, and the number of patients requiring rescue analgesia in each group was recorded. The occurrence of postoperative adverse reactions and postoperative pulmonary complications (PCCs) within one week after surgery were recorded. The postoperative quality of recovery was evaluated using the QOR-15 scale at 24 and 48 hours after surgery,and the postoperative hospital stay was recorded.

Effect of Subanesthetic Dose of Esketamine on Sleep Quality

The goal of this clinical trial is to explore whether subanesthetic doses of esketamine can improve the sleep quality of patients undergoing modified radical mastectomy for breast cancer. In this study, 184 people are expected to participate from admission to three days after surgery. The process requires participants to cooperate with the completion of the digital rating scale, the Athens Insomnia Scale, the Visual Analog Pain Rating Scale, the Hospital Anxiety and Depression Rating Scale, and the collection of venous blood for research indicators (IL-6, TNF-α, cor, BDNF). If participants agree to participate in this study, the investigators will assign a unique identification number to each participant and create a medical record for participants. One day before surgery, the investigators will conduct assessments using the Athens Insomnia Scale, the Visual Analog Pain Rating Scale, and the Hospital Anxiety and Depression Scale, and collect approximately 6 mL of venous blood. One day after surgery, the investigators will repeat the assessments using the Athens Insomnia Scale, the Visual Analog Pain Rating Scale, and the Hospital Anxiety and Depression Scale. Additionally, the investigators will collect another 6 mL of venous blood and monitor the use of analgesics. The investigators will follow up with participants three days after the surgery. During this follow-up, investigators will assess any sleep disturbances, administer the Hospital Anxiety and Depression Scale, and review the use of analgesics.

Fentanyl or Esketamine for Traumatic PAIN (FORE-PAIN) Trial

Fentanyl and esketamine are both standard of care for treatment of acute severe traumatic pain in the prehospital setting in the Netherlands. However, it is not known whether they are equally effective and safe. It is also not known whether intranasal (IN) administration of fentanyl or esketamine is equally effective and safe as intravenous (IV) administration. The FORE-PAIN trial is a double-blind multi-arm randomized non-inferiority trial comparing Fentanyl IN, esketamine IV and esketamine IN (intervention arms) to fentanyl IV (comparator arm) for prehospital management of traumatic pain. The investigators hypothesize that all intervention arms provide analgesia that is non-inferior to the comparator arm, and that all study arms are equally safe.

Esketamine on Postoperative Sleep Disturbance of Patients Undergoing Spinal Surgery

The goal of this clinical trial is to learn about the effect of intraoperative esketamine infusion on postoperative sleep disturbance(PSD) of patients undergoing spinal surgery. The main aims to answer are: * To explore the effect of intraoperative infusion of esketamine on the incidence of postoperative sleep disturbance and sleep quality in patients undergoing spinal surgery. * To explore the effect of intraoperative infusion of esketamine on postoperative pain, anxiety and depression ; Participants will be patients undergoing spinal surgery with general anesthesia at Beijing Tiantan Hospital. 0.3mg/kg/h esketamine or saline will be infused during surgery . The incidence of sleep disturbance , sleep quality, pain scores, hospital anxiety and depression scores and perioperative adverse events after surgery will be investigated.

Mini-dose Dexmedetomidine-Esketamine Supplemented Analgesia in Patients at High-risk of OSA

Patients with obstructive sleep apnea (OSA) are at increased risk of developing sleep disturbances after surgery. Dexmedetomidine is a highly selective α2-adrenergic agonist with sedative, analgesic, and anxiolytic effects. Ketamine is a noncompetitive N-methyl-d-aspartate (NMDA) receptor antagonist. Esketamine is the S-enantiomer of racemic ketamine and twice as potent as racemic ketamine for analgesia. A recent trial showed that mini-dose esketamine-dexmedetomidine in combination with opioids improved analgesia and subjective sleep quality after scoliosis correction surgery. This trial is designed to test the hypothesis that mini-dose dexmedetomidine-esketamine supplemented analgesia may improve postoperative sleep quality in patients at high-risk of OSA.

Esketamine in Microelectrode Recording-guided Subthalamic Deep-Brain Stimulation for Parkinson's Disease

Under regional anesthesia, subthalamic nucleus deep brain stimulation (STN-DBS) has proven to be an effective therapeutic approach for improving motor symptoms in Parkinson's disease. However, a significant portion of Parkinson's disease (PD) patients is unable to cooperate with the surgery, necessitating the use of awake sedation. Nevertheless, the administration of anesthetic drugs often impacts the electrical signals recorded by microelectrodes to varying degrees. This study is designed as a prospective, randomized, placebo-controlled, double-blind, two-arm investigation. PD patients scheduled for bilateral STN-DBS surgery will be randomly assigned to either the Dexmedetomidine group or the Dexmedetomidine combined with Esketamine group. The differences in neural activity between the two groups will be assessed using the normalized root mean square (NRMS) method. The primary outcome measure is NRMS, while secondary outcome measures include differences in beta oscillation power spectrum analysis, postoperative delirium incidence, postoperative changes in sleep disturbances, postoperative depression, anxiety status, and occurrence of adverse events.

Effect of Esketamine on Conscious State in Patients With pDoC

The goal of this clinical trial is to learn about the effect of intraoperative infusion of subanesthetic dose of esketamine on conscious status in patients with prolonged disorders of consciousness under sevoflurane anesthesia. Participants will be patients with prolonged disorders of consciousness undergoing surgery with general anesthesia at Beijing Tiantan Hospital. 0.3mg/kg esketamine or saline will be infused will be infused intravenously at a constant speed within 30 min after tracheal intubation/pneumatectomy fixation. Coma recovery scale-revised, Glasgow coma scale, Full Outline of UnResponsiveness scores, SedLine multi-channel electroencephalogram and perioperative adverse events after surgery will be investigated.