Clinical trial NCT05533567: Electroencephalographic Profiles During General Anesthesia: a Comparative Study of Remimazolam and Propofol
Official title: Electroencephalographic Profiles During General Anesthesia: a Comparative Study of Remimazolam and Propofol
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: General Anesthesia
Electroencephalography
Laparoscopic Cholecystectomy
Remimazolam
Propofol
Keywords: Electroencephalography
General Anesthesia
Remimazolam
Propofol
Laparoscopic Cholecystectomy
Lead sponsor: Second Affiliated Hospital of Nanchang University
Sponsor class: OTHER
First posted: 2022-09-09
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: EEG waveforms
timeFrame: Duration from the time the patient enters the operating room to the time they leave the post-anesthesia care unit, average two hours.
Secondary outcomes:
measure: systolic pressure
timeFrame: Up to 5 hours including preoperative, intraoperative, and postoperative periods
measure: diastolic pressure
timeFrame: Up to 5 hours including preoperative, intraoperative, and postoperative periods
measure: mean pressure
timeFrame: Up to 5 hours including preoperative, intraoperative, and postoperative periods
measure: heart rate
timeFrame: Up to 5 hours including preoperative, intraoperative, and postoperative periods
measure: pulse
timeFrame: Up to 5 hours including preoperative, intraoperative, and postoperative periods
measure: Recovery times
timeFrame: Up to 30 minutes after operation
measure: Complication
timeFrame: During the perioperative period
Other outcomes:
Locations:
city: Nanchang
country: China
facility: the Second Affiliated Hospital of Nanchang University, Nanchang University
state: Jiangxi
Study officials:
References: