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Differential Effects of Remimazolam and Propofol on Dynamic Cerebral Autoregulation During General Anesthesia

Differential Effects of Remimazolam and Propofol on Dynamic Cerebral

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05533580
Enrollment
50
Registered
2022-09-09
Start date
2022-10-01
Completion date
2023-01-31
Last updated
2022-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dynamic Cerebral Autoregulation, General Anesthesia, Laparoscopic Cholecystectomy, Propofol, Remimazolam

Keywords

General Anesthesia, Laparoscopic Cholecystectomy, Remimazolam, Propofol, dynamic cerebral autoregulation

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.

Interventions

DRUGRemimazolam

The experimental group was sedated with remimazolam.

DRUGPropofol

The control group was sedated with propofol.

Sponsors

Second Affiliated Hospital of Nanchang University
Lead SponsorOTHER

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. 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.

Design outcomes

Primary

MeasureTime frameDescription
Differences in dynamic cerebral blood flow autoregulationFrom the time the patient enters the operating room to the time they leave the operating room, one and a half hours on average.Comparison of the consistency, gain and phase of the transfer function parameters in the frequency range of 0.02-0.07 Hz, 0.07-0.2 Hz and 0.2-0.5 Hz for the propofol and rimazolam groups, respectively.

Secondary

MeasureTime frameDescription
diastolic pressureUp to 5 hours including preoperative, intraoperative, and postoperative periodsIndicators related to perioperative hemodynamics
mean pressureUp to 5 hours including preoperative, intraoperative, and postoperative periodsIndicators related to perioperative hemodynamics
heart rateUp to 5 hours including preoperative, intraoperative, and postoperative periodsIndicators related to perioperative hemodynamics
systolic pressureUp to 5 hours including preoperative, intraoperative, and postoperative periodsIndicators related to perioperative hemodynamics
Recovery timesUp to 30 minutes after operationThe 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.
ComplicationDuring the perioperative periodAll the perioperative complications are recorded.
pulseUp to 5 hours including preoperative, intraoperative, and postoperative periodsIndicators related to perioperative hemodynamics

Countries

China

Contacts

Primary ContactFuzhou Hua, professor
huafuzhou@126.com+8615170238929
Backup ContactXing Liu, Dr.
liuxingmed@163.com+8618379804346

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026