Clinical trial NCT06775366: The Effect of General Anesthesia with Remimazolam and Propofol on Rhythmic State and Cognitive Function
Official title: Effects of General Anesthesia with Remimazolam and Propofol on Rhythmic State and Cognitive Function
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cognitive Functioning
Propofol
Remimazolam
Circadian Rhythm
Lead sponsor: The Second Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2025-01-15
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study want to observe the effects of remimazolam and propofol for general anesthesia on postoperative rhythm and cognitive function. The observation group was given remimazolam for general anesthesia, and the control group was given propofol for general anesthesia. Both drugs are commonly used as intravenous anesthetics for general anesthesia and have been shown to be safe for use in general anesthesia. The investigators hope can understand the effects of remimazolam and propofol for general anesthesia on rhythm status and cognitive function through this study, further reduce the occurrence of postoperative cognitive function impairment, and enable subjects to better recover.

Detailed description: Benzodiazepines are one of the most important and commonly used intravenous sedatives in the perioperative period. However, benzodiazepines are often associated with a variety of side effects, including respiratory depression, cardiovascular depression, excessive sedation, delayed recovery, disturbance of consciousness, dizziness and nausea, postoperative delirium, and postoperative cognitive impairment. Remimazolam is a new type of benzodiazepine anesthetic drug. It can be rapidly hydrolyzed into inactive carboxylic acid metabolites by widely existing carboxylesterases in the human body. Therefore, it has the characteristics of fast onset, fast metabolism, little impact on liver and kidney function, and little inhibition of respiratory circulation. However, as a benzodiazepine, remimazolam has little effect on postoperative cognitive function.

Biorhythms are currently a hot topic in medical research. Many organisms, including mammals, have the suprachiasmatic nucleus (SCN), a circadian clock pacemaker located in the hypothalamus, which drives the rhythms of activity and rest, fasting and eating, body temperature and hormones to synchronize to 24 hours. Many anesthetic drugs, such as propofol, dexmedetomidine, and volatile anesthetic drugs such as sevoflurane and desflurane, interfere with the expression of circadian rhythm genes in mammals. For example, the expression of rhythm genes per1 and per2 in supratasmatic nucleus of rats injected with a single dose of propofol is down-regulated, and irregular resting activity rhythm is observed in patients undergoing colonoscopy under anesthesia with propofol. The circadian period of patients undergoing general anesthesia is obviously advanced, and the disturbance of circadian rhythm is an important feature of postoperative sleep disorders. However, sleep disorders can aggravate postoperative delirium and postoperative cognitive dysfunction, and related rhythm genes such as Dbp participate in the plasticity of the hippocampus, so the interference of anesthesia drugs on the biological rhythm of the body may be an important cause of postoperative cognitive dysfunction. Since propofol is commonly used in clinical intravenous anesthesia, this study intends to compare the effects of remimazolam and propofol on patients' activity rest rhythm and their effects on learning and memory functions.

Eligibility criteria: Inclusion Criteria:

Age 18-65 years old, ASAI-III class, BMI18.5-25kg/m2 Inpatients undergoing laparoscopic cholecystectomy The estimated time of operation is 1.5\~2.5 hours Preoperative brief mental status examination (MMSE) score ≥24 Voluntary participation and signed informed consent

Exclusion Criteria:

Pregnant or lactating women Patients who are allergic to remimazolam or contraindicated Patients who are dependent on or tolerant to opioids or have long-term alcoholism Serious cardiovascular system, respiratory system, liver and kidney diseases History of obstructive sleep apnea mental disorders or neurological diseases Patients who participated in clinical trials of other drugs within the last 3 months The attending physician or researcher considers that there are other circumstances that are not suitable for participation in this study Refuse to participate in the study

Primary outcomes:
measure: Cognitive function
timeFrame: 30 minutes after extubation and 24 hours after surgery
measure: Cognitive function
timeFrame: 30 minutes after extubation and 24 hours after surgery
measure: Cognitive function
timeFrame: 30 minutes after extubation and 24 hours after surgery
measure: Cognitive function
timeFrame: 30 minutes after extubation and 24 hours after surgery
measure: Cognitive function
timeFrame: 30 minutes after extubation and 24 hours after surgery
Secondary outcomes:
measure: Patient activity/rest condition
timeFrame: 30 minutes after extubation and 24 hours after surgery
measure: The quality of recovery score
timeFrame: 24 hours after surgery to complete the QoR-15 score assessment
measure: ramsay sedation score
timeFrame: 30min after extubation to complete the ramsay sedation score assessment
measure: Anesthesia adverse events
timeFrame: during surgery
measure: drug-related adverse reactions
timeFrame: during surgery
measure: Use of vasoactive drugs
timeFrame: during surgery
measure: fluid volume
timeFrame: during surgery
measure: Record the time of extubation
timeFrame: From the end of the surgery to leaving the postoperative recovery room
measure: Numerical rating scale 24 hours after surgery
timeFrame: from 24 hours after surgery to complete the NRS pain assessment
measure: Postoperative nausea numerical rating scale
timeFrame: from 24 hours after surgery to complete the postoperative nausea NRS score
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The Second Affiliated Hospital of Chongqing Medical University
Study officials:
References: