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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Cognitive function — 30 minutes after extubation and 24 hours after surgery
  The digital symbol task was measured 30 minutes after extubation and 24 hours after surgery to assess the patient's attention and executive ability. The test requires subjects to quickly transcribe numbers into symbols within their line of sight. The score is the number of correct numeric symbols recorded by the subject within 20 seconds.
• Cognitive function — 30 minutes after extubation and 24 hours after surgery
  The finger tap test was measured 30 minutes after extubation and 24 hours after surgery to assess the fine motor ability. The average stroke number of a normal person within a 10-second time limit is about 40, and the speed of the right hand is about 1.1 times that of the left hand. The test includes a keystroke and a device that records the number of keystrokes. We performed this test using a tablet: a square area was placed in the middle of the screen to allow the subject to click as quickly as possible, while the tablet automatically recorded the completion time.The subjects were asked to complete 10 seconds of tapping with each hand separately and take short breaks between each test.Record the number of strokes each hand completes in 10 seconds.
• Cognitive function — 30 minutes after extubation and 24 hours after surgery
  The digital span test was measured 30 minutes after extubation and 24 hours after surgery to assess the short-term memory. The digital span test assays memory ability and attention span by having subjects recall the correct number immediately after seeing a randomly appearing string of numbers and input it into an electronic device, and increase the length of the string one digit at a time after remembering it correctly. Record the length of the numeric string that the subject can eventually recall.
• Cognitive function — 30 minutes after extubation and 24 hours after surgery
  The stroop color word test was measured 30 minutes after extubation and 24 hours after surgery to assess the distraction and conditioned reflex suppression. Mixing words with different colors and meanings and the same meaning in the center of the screen (for example, on the word "green" written in red) requires subjects to quickly select the meaning of the word and suppress automatic reflexes to recognize the color. Record the subject completion time.
• Cognitive function — 30 minutes after extubation and 24 hours after surgery
  The schulte square test was measured 30 minutes after extubation and 24 hours after surgery to assess the patient attention level ability. The investigators used a tablet to do this test: there are 16 grids in the center of the screen. The grid is arbitrarily filled with Arabic numerals 1-16, with a total of 16 digits. During the test, participants were asked to manually click on number locations in order of 1-16, and only after clicking the correct location could they proceed to the next number click. The software automatically records the time spent. Subjects were asked to complete two trials each time, with a short break between each trial, and to record the shortest time to complete the trial between the two tests.

Trial sites (1)

More The Second Affiliated Hospital of Chongqing Medical University trials in China

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