NCT06775366

The Effect of General Anesthesia with Remimazolam and Propofol on Rhythmic State and Cognitive Function

Effects of General Anesthesia with Remimazolam and Propofol on Rhythmic State and Cognitive Function

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 174 (estimated)
• Sponsor: The Second Affiliated Hospital of Chongqing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cognitive Functioning
• Propofol
• Remimazolam
• Circadian Rhythm

Interventions

Type	Name	Description
DRUG	Remimazolam	Remimazolam 6mg/kg/h was pumped intravenously for 2.5 min, Sufentanil 0.5 μg/kg and rocuronium 0.6mg/kg were injected intravenously, and endotracheal intubation was performed 3 minutes later. Remimazolam was then pumped at 1 mg/kg/h, the BIS was kept in the range of 40-60 through general anesthesia, and the remimazolam infusion rate was adjusted (0.5-3 mg/kg/h).If the BIS cannot be maintained at ≤ 60 or there are signs of potential inadequate anesthesia (such as cough, sweating, and patient movement), and the maximum infusion dose of remimazolam has been given, supplemental sedation with the remedial drug sevoflurane or propofol is used and the case is dismissed.
DRUG	propofol	Propofol (2-3mg/kg), Sufentanil (0.5μg /kg), rocuronium (0.6mg/kg) were injected intravenously, and endotracheal intubation was performed for 3 minutes. Subsequently, propofol was pumped at 4-10mg/kg/h to maintain the BIS in the range of 40-60.

Timeline

• Start date: 2025-02-24
• Primary completion: 2026-04-30
• Completion: 2026-05-30
• First posted: 2025-01-15
• Last updated: 2025-02-14

Locations

1 site across 1 country: China