Clinical trials

Background: During thoracoscopic lobectomy in elderly patients, one-lung ventilation (OLV) is a common procedure. However, this process is prone to cause hypoxemia and postoperative cognitive dysfunction (POCD), which seriously affect the postoperative recovery and prognosis of patients. At present, there is still a need for further exploration and optimization of effective anesthetic drugs and regimens to improve intraoperative oxygenation and reduce the occurrence of POCD in such patients. Remimazolam besylate, as a novel anesthetic drug, has not yet had its advantages in thoracoscopic surgery in elderly patients fully clarified. This study is conducted to explore its effects on oxygenation and postoperative cognitive function in this specific surgical setting, so as to provide new references for clinical drug use and improve the perioperative management and postoperative outcomes of elderly patients. Objective:To mainly investigate the effects of remimazolam besylate on oxygenation and intrapulmonary shunting during one-lung ventilation in elderly patients undergoing thoracoscopic surgery, as well as its impact on postoperative cognitive dysfunction. Research Content:The research content includes the observation and evaluation of oxygenation index, shunt fraction, cognitive function status, intraoperative conditions (such as OLV duration, blood loss, etc.),hemodynamic indicators, blood gas analysis indicators, serum indicators, and postoperative recovery status (such as postoperative sedation, pain, adverse reactions, pulmonary complications, hospital stay duration, etc.) in elderly patients undergoing thoracoscopic lobectomy. Research Methods: Study Design: A randomized controlled study will be adopted. Case Selection: Inclusion Criteria: Patients aged 65-75 years old, with a BMI of 18-30 kg/m², ASA classification of I-III, no contraindications to related drugs, and consent from the patient and their family to participate in the study and sign the informed consent form, who are scheduled for thoracoscopic surgery under general anesthesia at the First Affiliated Hospital of Kunming Medical University from December 2024 to December 2025, will be selected. Exclusion Criteria: Patients with severe arrhythmias, preoperative respiratory tract infections, central nervous system diseases, hepatic or renal insufficiency, immune system diseases, a history of preoperative radiotherapy or chemotherapy, communication barriers, etc., will be excluded. Exclusion Criteria: Patients with OLV duration less than 60 minutes or conversion to thoracotomy, intraoperative blood loss greater than 1000 ml, and those transferred to the ICU after surgery will be excluded. Grouping and Anesthesia Methods: Patients will be randomly divided into three groups: Remimazolam Group (R Group), Propofol Group (P Group), and Remimazolam Combined with Propofol Group (C Group), with 50 cases in each group. After anesthesia induction, the three groups will be maintained with different drugs and doses until 10 minutes before the end of the surgery, while remifentanil will be combined, and the infusion rate of the drugs will be adjusted according to the BIS value. Data Collection: Detailed records will be kept of the patient's general information, intraoperative conditions, perioperative cardiovascular reactions, blood gas analysis indicators, serum indicators, as well as postoperative cognitive function assessment, sedation and pain assessment, adverse reactions, and complications. Sample Size Calculation: Based on the oxygenation index at 60 minutes of OLV, which is the primary endpoint, and in combination with relevant literature and statistical requirements, the sample size for each group is calculated to be 58. Considering the dropout and withdrawal rates, the final sample size for each group is determined to be 70. Statistical Analysis: SPSS 27.0 software will be used. Normal distribution measurement data, non-normal distribution measurement data, and count data will be analyzed using independent sample t-test, Wilcoxon rank-sum test, and chi-square test or Fisher's exact probability method, respectively. A P value less than 0.05 will be considered statistically significant. Technical and Feasibility Assurance: Relying on the clinical resources and technical platform of the First Affiliated Hospital of Kunming Medical University, as well as the research team's proficiency in thoracic anesthesia techniques and the operation of related equipment, the smooth conduct of the study will be ensured.

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.