Clinical trial NCT05533580: Differential Effects of Remimazolam and Propofol on Dynamic Cerebral Autoregulation During General Anesthesia
Official title: Differential Effects of Remimazolam and Propofol on Dynamic Cerebral
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: General Anesthesia
Laparoscopic Cholecystectomy
Remimazolam
Propofol
Dynamic Cerebral Autoregulation
Keywords: General Anesthesia
Laparoscopic Cholecystectomy
Remimazolam
Propofol
dynamic cerebral autoregulation
Lead sponsor: Second Affiliated Hospital of Nanchang University
Sponsor class: OTHER
First posted: 2022-09-09
Enrollment: 50
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: Cerebral autoregulation (CA) is the property of the cerebral vascular bed to maintain cerebral perfusion in the presence of changes in blood pressure. In the case of anesthesia, altered cerebral autoregulation, including altered carbon dioxide and hemodilution, can impair physiological changes in the body and lead to poor postoperative prognosis. 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. Our study aimed to investigate the different effects of remimazolam and propofol on dynamic cerebral blood flow autoregulation function during general anesthesia.


Eligibility criteria: Inclusion Criteria:

1. Age 18-60 years, gender not limited
2. Patients proposed to undergo elective laparoscopic cholecystectomy under general anesthesia, with an expected operative length of approximately 1h\~2h
3. Good penetration of the temporal window.
4. ASA anesthesia classification grade I to II.
5. can communicate effectively with the physician.
6. Patients were aware of and voluntarily signed the informed consent form.

Exclusion Criteria:

1. Relative contraindications to general anesthesia: patients with severe heart and lung function diseases.
2. History of syncope, and dizziness.
3. Patients with a history of psychiatric disorders, neurological disorders, drug abuse, or drug addiction
4. Patients with cerebrovascular or carotid artery lesions;
5. Those who are unable to cooperate in completing the test
6. Persons who have taken benzodiazepines intermittently in the last three months.
7. Those with known allergies or allergies to the test drug.

Primary outcomes:
measure: Differences in dynamic cerebral blood flow autoregulation
timeFrame: From the time the patient enters the operating room to the time they leave the operating room, one and a half hours on average.
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: