Remimazolam: Remimazolam group (Group R) : After intubation, remimazolam was maintained at a pump rate of 1-2mg/kg/h until ten minutes before the end of the operation. Group C (remimazolam combined with propofol): After intubation, maintain with 0.3-1 mg/kg/h of remimazolam and 3-6 mg/kg/h of propofol until 10 minutes before the end of surgery.
Propofol: Propofol group (Group P) : After intubation, propofol was maintained at a pump rate of 4-10mg/kg/h until surgery ten minutes before the end. Group C (remimazolam combined with propofol): After intubation, maintain with 0.3-1 mg/kg/h of remimazolam and 3-6 mg/kg/h of propofol until 10 minutes before the end of surgery.
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.
| Facility | City | Region | Status |
|---|---|---|---|
| The First Affiliated Hospital of Kunming Medical University | Kunming | Yunnan |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07086911 on ClinicalTrials.gov ↗ ← All trials in China