The Impact of Remimazolam Tosilate on Oxygenation and Postoperative Cognitive Function in Elderly Patients Undergoing Thoracoscopic Lobectomy

NCT07086911 | Not Yet Recruiting Phase 1

• 1 other identifier: ZKL-KY20241015-78
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Remimazolam Besylate; Thoracoscopic Lobectomy; Oxygenation; Postoperative Cognitive Dysfunction

Outcome Measures

Primary Outcomes (2)

• (1)The oxygenation index and shunt fraction of the patients at different times;

  (1) Oxygenation index and shunt fraction of patients at different times: before one-lung ventilation (T1), 30 minutes of one-lung ventilation (T2), 60 minutes of one-lung ventilation (T3).

  perioperative

• (2)Cognitive function situation

  (2) cognitive function: POCD occurs within 7 days following surgery.

  within 7days following surgery

Study Arms (3)

Remimazolam Group (Group R)

EXPERIMENTAL

After intubation, remimazolam was maintained at a pump rate of 1-2mg/kg/h until 10 minutes before the end of the operation.

Drug: Remimazolam

Propofol group (Group P)

ACTIVE COMPARATOR

After intubation, propofol was maintained at a pump rate of 4-10mg/kg/h until 10 minutes before the end of the operation

Drug: Propofol

Remimazolam combined with propofol group (Group C)

EXPERIMENTAL

After intubation, remimazolam at a dose of 0.3-1mg/kg/h and propofol at a dose of 3-6 mg/kg/h were maintained until 10 minutes before the end of the operation

Drug: Remimazolam; Drug: Propofol

Interventions

Remimazolam DRUG

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.

Remimazolam Group (Group R); Remimazolam combined with propofol group (Group C)

Propofol DRUG

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.

Propofol group (Group P); Remimazolam combined with propofol group (Group C)

Eligibility Criteria

• Age: 65 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients scheduled for thoracoscopic surgery under general anesthesia at the First Affiliated Hospital of Kunming Medical University;
• Age 65 to 75 years old;
• BMI18-30 kg/m ²;
• ASA grades I to III;
• There are no contraindications to any related drugs;
• Both the patient and their family members agreed to participate in this study and signed the informed consent form

You may not qualify if:

• Patients with severe sinus bradycardia (heart rate \<50 beats per minute) and atrioventricular block;
• Respiratory tract infection and the use of non-steroidal anti-inflammatory drugs or hormone drugs within 2 weeks before the operation;
• Those with central nervous system and psychological disorders;
• Have taken anticholinergic drugs, anticonvulsants, anti-anxiety drugs, antidepressants, etc. in the past half year;
• Severe liver and kidney dysfunction and immune system diseases, uncontrolled hypertension and diabetes;
• History of preoperative radiotherapy and chemotherapy;
• Patients with communication barriers who are unable to cooperate to complete the test;
• The OLV \< 60 min or interim thoracotomy patients;
• Intraoperative blood loss \> 1500ml;
• Patients transferred to the ICU ward after the operation.

Sponsors & Collaborators

• Jinqiao Qian: lead

Study Sites (1)

The First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650032, China

Location

MeSH Terms

Conditions

Postoperative Cognitive Complications

Interventions

remimazolam; Propofol

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Jinqiao Qian, doctor

  First Affiliated Hospital of Kunming Medical University

  STUDY DIRECTOR

Central Study Contacts

Zhuoran Wang, doctor

CONTACT

+86 18468116284; wangzhuoranbb@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The person responsible for grouping; Data analyst
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: deputy director

Model Details: Remimazolam group (Group R): After intubation, remimazolam was maintained at a pump rate of 1-2mg/kg/h until 10 minutes before the end of the surgery. Propofol group (Group P): After intubation, propofol was maintained at a pump rate of 4-10mg/kg/h until 10 minutes before the end of the surgery. Remimazolam combined with propofol group (Group C): After intubation, it was maintained at 0.3-1mg/kg/h of remimazolam +3-6 mg/kg/h of propofol until 10 minutes before the end of the operation.

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: July 25, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The sharing period is from August 2025 to August 2026.
• Access Criteria: All researchers have access to the IPD and supporting information. They can access the study protocol design, as well as subsequent data collection and analysis results. They can search for this information on this website by entering the study title.

Locations

CN (1)