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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorThe Second Affiliated Hospital of Chongqing Medical University

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Remimazolam

    Drug

    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

    Drug

    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.

Treatment groups

174 Participants
are divided into 2 treatment groups
Group A: remimazolam for general anesthesiaExperimental treatment 1 intervention
Group B: propofol for general anesthesiaActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Cognitive function

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.

Time frame
30 minutes after extubation and 24 hours after surgery
2

Cognitive function

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.

Time frame
30 minutes after extubation and 24 hours after surgery
3

Cognitive function

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.

Time frame
30 minutes after extubation and 24 hours after surgery
4

Cognitive function

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.

Time frame
30 minutes after extubation and 24 hours after surgery

Secondary outcomes

1

Patient activity/rest condition

From 24 hours before surgery to 24 hours after surgery, the patient will wear a Huawei sports bracelet to record the patient's activity and rest condition

Time frame
30 minutes after extubation and 24 hours after surgery
2

The quality of recovery score

The quality of postoperative recovery was assessed by quality of recovery score-15(QoR-15). The quality of postoperative recovery score includes 15 questions, with a maximum of 10 points for each question, a maximum of 150 points, and a minimum of 0 points. The higher the score, the better the patient's recovery quality.

Time frame
24 hours after surgery to complete the QoR-15 score assessment
3

ramsay sedation score

The degree of sedation was assessed by ramsay sedation score.1 score: restlessness;2 points: sober, quiet and cooperative;3 points: lethargy, quick response to instructions;4 points: light sleep state, can quickly wake up;5 points: sleep, slow response to calls;6 points: Deep sleep, unresponsive to calls.

Time frame
30min after extubation to complete the ramsay sedation score assessment
4

Anesthesia adverse events

such as hypotension, hypertension, bradycardia or other anesthesia adverse events

Time frame
during surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: