Electroencephalography, General Anesthesia, Laparoscopic Cholecystectomy, Propofol, Remimazolam
Conditions
Keywords
Electroencephalography, General Anesthesia, Remimazolam, Propofol, Laparoscopic Cholecystectomy
Brief summary
How anesthetic drugs induce and maintain the behavioral state of general anesthesia is an important question in medicine and neuroscience. Different anesthetic drugs act on different molecular targets and neural circuit mechanisms, exhibiting drug-specific EEG features. As a novel ultra-short-acting benzodiazepines drugs, remimazolam has been accepted for induction and maintenance of clinical anesthesia. Compared to the traditional benzodiazepines drugs, remimazolam combines the safety of midazolam with the effectiveness of propofol, and also has the advantages of acting quickly, short half-life, no injection pain, slight respiratory depression, independent of liver and kidney metabolism, long-term infusion without accumulation, and has a specific antagonist: flumazenil. This study aimed to investigate the differences in the characteristics of EEG oscillations during general anesthesia by comparing propofol and remimazolam.
Interventions
DRUGRemimazolam
The experimental group was sedated with remimazolam.
DRUGPropofol
The control group was sedated with propofol.
Sponsors
Second Affiliated Hospital of Nanchang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Right-handed, age 18-60 years, sex not limited. 2. Patients proposed to undergo elective laparoscopic cholecystectomy under general anesthesia in the morning, with an expected operative duration of approximately 1h to 2h. 3. Body mass index (BMI) \<28 kg/m2. 4. Anxiety score \>50, both without anxiety and sleep disorders. 5. ASA anesthesia classification grade I with Mallampati class I airway anatomy. 6. Can communicate effectively with the physician. 7. Patients were aware of and voluntarily signed the informed consent form.
Exclusion criteria
1. Relative contraindications to general anesthesia: patients with severe cardiac or pulmonary function disease. 2. Patients taking drugs that may confound EEG or behavioral findings or during pregnancy. 3. Patients with a history of psychiatric or neurological disorders, drug abuse, or drug addiction. 4. Any cerebrovascular accident within 3 months, such as stroke, transient ischemic attack (TIA), etc.; 5. Inability to cooperate in completing the test, or refusal of the patient or family members to participate. 6. Those with known allergies, or allergies to the test drug.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EEG waveforms | Duration from the time the patient enters the operating room to the time they leave the post-anesthesia care unit, average two hours. | Contrasting differences in electroencephalographic oscillatory characteristics during general anesthesia with propofol and remimazolam. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| diastolic pressure | Up to 5 hours including preoperative, intraoperative, and postoperative periods | Indicators related to perioperative hemodynamics |
| mean pressure | Up to 5 hours including preoperative, intraoperative, and postoperative periods | Indicators related to perioperative hemodynamics |
| heart rate | Up to 5 hours including preoperative, intraoperative, and postoperative periods | Indicators related to perioperative hemodynamics |
| systolic pressure | Up to 5 hours including preoperative, intraoperative, and postoperative periods | Indicators related to perioperative hemodynamics |
| Recovery times | Up to 30 minutes after operation | The period from discontinuation of anesthetic drugs to the recovery of the patient's self-consciousness and can respond correctly to external stimuli. All the patients can be allowed to leave the post-anesthesia care unit after Aldrete ≥ 9. Delayed awakening is defined as failure to achieve Aldrete ≥ 9 more than 30 minutes after surgery. |
| Complication | During the perioperative period | All the perioperative complications are recorded. |
| pulse | Up to 5 hours including preoperative, intraoperative, and postoperative periods | Indicators related to perioperative hemodynamics |
Countries
China
Contacts
Primary ContactFuzhou Hua, professor
Backup ContactDanying Yang, Dr.
Outcome results
None listed