Clinical trials

Obesity is a growing global health problem, and patients with obesity are at higher risk of hypoxemia during induction of general anesthesia. This is because excess body weight reduces the lungs' oxygen storage capacity, causing blood oxygen saturation to decline faster than in normal-weight individuals once breathing stops. Currently, the most common preventive method is preoxygenation with a face mask delivering 100% oxygen for several minutes before anesthesia induction. However, face masks often fail to seal properly in obese patients, potentially compromising preoxygenation effectiveness. High-flow nasal oxygen therapy is a newer technique that delivers heated and humidified oxygen at high flow rates through nasal cannulae. It not only provides effective preoxygenation but may also continue to supply oxygen during apnea (apneic oxygenation), thereby prolonging the safe apnea time. Nevertheless, it remains unclear which flow rate is most effective and whether high-flow nasal oxygen is truly superior to conventional face masks. This prospective randomized controlled trial will enroll 147 obese patients (BMI ≥ 28kg/m²) scheduled for elective surgery at Lianyungang First People's Hospital. Participants will be randomly assigned to one of three groups: (1) traditional face mask preoxygenation at 15 L/min, (2) high-flow nasal oxygen at 45 L/min, or (3) high-flow nasal oxygen at 70 L/min. All patients will receive 100% oxygen for 3 minutes. The primary outcome is safe apnea time - the duration from cessation of breathing until SpO₂ drops to 93%. Secondary outcomes include arterial blood gas values, patient comfort during preoxygenation, tolerance rate, and hemodynamic stability. The study hypothesis is that high-flow nasal oxygen at 70 L/min will provide a longer safe apnea time than both traditional face mask preoxygenation and high-flow nasal oxygen at 45 L/min in obese patients. The results will provide high-quality evidence for optimizing perioperative preoxygenation strategies in this population.

This is a prospective, single-arm phase II clinical study. It intends to evaluate the efficacy and safety of stereotactic radiation therapy (SRT) combined with envafolimab and endostar as first-line treatment in stage IV non-small cell lung cancer (NSCLC) patients without actionable EGFR/ALK/ROS1 driver gene alterations and with PD-L1 TPS ≥ 1%. A total of 61 eligible participants will receive combination treatment of stereotactic radiotherapy, envafolimab and endostar. Tumor response will be evaluated every 6 weeks according to RECIST v1.1, and treatment-related adverse events will be monitored based on NCI-CTCAE v5.0. The treatment will continue until disease progression, patient withdrawal, loss of follow-up or death.

This is a randomized, double-blind, active-controlled clinical study evaluating the efficacy and safety of Anrikefon (HSK21542) Injection for patient-controlled analgesia (PCA) in patients undergoing thoracoscopic lung surgery. Subjects aged 18-85 years with a postoperative resting NRS score ≥ 4 will be enrolled. Eligible participants will be randomized 1:1 to receive either Anrikefon (HSK21542) or sufentanil via PCA pump for 24 hours post-surgery. The primary endpoint is the 24-hour summed pain intensity difference (SPID₂₄). A total of 88 subjects are planned for enrollment. The study has received ethics committee approval.

Postpartum depression (PPD) is a common mental health condition affecting 10%-30% of new mothers, with serious consequences for both mother and child. Effective prevention is limited by barriers to psychological or pharmacological treatments. This study evaluates whether short-term 40 Hz light and sound stimulation during and immediately after elective cesarean section can reduce PPD risk. The intervention group receives three 30-minute sessions of combined 40 Hz flashing light and pulsed sound (starting after baby delivery, then at 24 and 48 hours postpartum). The control group receives identical non-flickering light and white noise as placebo.The main outcome is the Edinburgh Postnatal Depression Scale score at 42 days postpartum. Secondary outcomes include depression rates, insomnia severity, and anxiety levels.Participants are women aged ≥18 years with single full-term pregnancy scheduled for elective cesarean section. Exclusion criteria include psychiatric disorders, epilepsy, or eye conditions affecting light sensitivity. If effective, this non-invasive, drug-free intervention could provide a safe and accessible PPD prevention strategy during routine cesarean delivery.

In patients undergoing general anesthesia with planned tracheal intubation , a prospective, randomized, controlled study was conducted to record the occurrence of cough 2 minutes after injection of Sufentanil or Tegilerdine. The cough was graded based on the frequency and duration: Grade I, no cough; Grade II, a single mild cough; Grade III, multiple coughs with duration \<1 second; Grade IV, continuous coughing with a duration \>15 seconds.

This clinical study aims to find out if a modified mini-open spine surgery (modified mini-open transforaminal lumbar interbody fusion，mMO-TLIF) is as good as, or better than, the traditional open surgery (traditional transforaminal lumbar interbody fusion，traditional TLIF) for treating low back pain, leg pain, and walking difficulties caused by lumbar spinal stenosis with instability. The study will also look at the safety of both surgeries. It is designed to answer these main questions: Is the mMO-TLIF surgery as good as the traditional TLIF surgery at improving patients' lower back function and quality of life? Does the mMO-TLIF surgery reduce blood loss during the operation and shorten hospital stays and recovery time? What medical problems (like infections or nerve injuries) might patients experience after having the mMO-TLIF surgery? Researchers will compare the results of the mMO-TLIF surgery group with the traditional TLIF surgery group to see which one works better. Participants will: Be randomly assigned to receive either the mMO-TLIF minimally invasive surgery or the traditional TLIF open surgery. Come back to the hospital for check-ups before surgery, and then at 1 month, 3 months, 12 months and 24 months after surgery. During these check-ups, they will have physical exams, fill out questionnaires about their symptoms, dysfunction and quality of life, and get X-rays or CT scans to see how their bones are healing.

This research protocol aims to investigate the 90% effective dose (ED90) of taiglididine for inhibiting laryngeal mask insertion response in elderly patients. It is a non-randomized controlled trial using a biased coin design up-down method (BCD-UDM). A total of 54 elderly patients aged 65-80 years with ASA I-III, BMI 18-30 kg/m², and suitable for urological surgery under general anesthesia with laryngeal mask insertion will be enrolled. The first patient receives an intravenous injection of 1 mg taiglididine, followed by propofol and rocuronium. Subsequent doses of taiglididine are adjusted dynamically based on the previous patient's response: increasing by 0.1 mg if the insertion response is positive, or using BCD-UDM (11% probability to decrease by 0.1 mg, 89% to remain) if negative. The primary efficacy endpoint is the occurrence of laryngeal mask insertion response, while secondary endpoints include adverse events, vital sign changes, insertion success rate, and various time intervals. Safety is evaluated by monitoring vital signs. Statistical analysis will use SPSS 25.0 and R software to calculate ED90 and 95% confidence intervals via probit regression and bootstrap method, with at least 45 valid patients required to complete the trial.

1. Objective: Primary: Compare the effect of Ciprofol vs Propofol on LVOT VTI at 2 minutes post-injection (T1) in elderly patients (≥65 years). Secondary: Assess hypotension incidence, injection pain, nausea/vomiting, hypoxia (SpO₂≤90%), bradycardia (HR\<50 bpm), sedation success rate, induction/recovery times, procedure duration, drug doses, and patient satisfaction. 2. Design: Single-center, randomized, double-blind, controlled trial. Group C (Ciprofol):0.2-0.5 mg/kg IV induction (\>30s injection). Group P (Propofol)::1-2 mg/kg IV induction (\>30s injection). Rescue doses allowed (C: 0.1 mg/kg; P: 0.5 mg/kg; max 5 doses/15 min). 3. Participants: N = 120 elderly patients (65-80 years, ASA I-III, BMI 18-30 kg/m²) scheduled for elective painless colonoscopy. Exclusion: Significant cardiorespiratory, hepatic, renal, or neurological disorders; recent MI/unstable angina (≤6 months); NYHA ≥II; drug allergies; recent trial participation. 4. Key Assessments: Primary Endpoint: LVOT VTI (via transthoracic echocardiography, TTE) at T1. Secondary Endpoints: Adverse events (hypotension, pain, nausea/vomiting, hypoxia, bradycardia, body movement, awareness). Sedation success rate, induction/recovery times (MOAA/S scale), procedure time. Drug doses (induction, total, vasoactive agents). Patient satisfaction (5-point scale). LVEF and IVC Collapse Index (TTE at T0, T1, T2). Safety: Vital signs (HR, BP, SpO₂). 5. Statistical Analysis: SPSS 26.0; α=0.05. Methods: t-test, RM-ANOVA, Mann-Whitney U, Chi-square/Fisher's exact, rank-sum tests. This study aims to determine whether Ciprofol provides superior hemodynamic stability (as measured by LVOT VTI) and fewer adverse effects compared to Propofol for sedation in elderly patients undergoing painless colonoscopy.

To evaluate the efficacy and safety of SRT combined with anlotinib in the treatment of limited brain metastases from non-small cell lung cancer.