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

General Anesthesia Clinical Trial

Official title:

Differential Effects of Remimazolam and Propofol on Dynamic Cerebral

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05533580
• Other study ID #: 2022-TCD-1
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: January 31, 2023

Study information

• Verified date: September 2022
• Source: Second Affiliated Hospital of Nanchang University
• Contact: Fuzhou Hua, professor
• Phone: +8615170238929
• Email: huafuzhou[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 31, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• General Anesthesia
• Laparoscopic Cholecystectomy
• Propofol
• Remimazolam

Intervention

Drug:
• Remimazolam
The experimental group was sedated with remimazolam.
• Propofol
The control group was sedated with propofol.

Locations

Country	Name	City	State
China	the Second Affiliated Hospital of Nanchang University, Nanchang University	Nanchang	Jiangxi

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Nanchang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in dynamic cerebral blood flow autoregulation	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.	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	systolic pressure	Indicators related to perioperative hemodynamics	Up to 5 hours including preoperative, intraoperative, and postoperative periods
Secondary	diastolic pressure	Indicators related to perioperative hemodynamics	Up to 5 hours including preoperative, intraoperative, and postoperative periods
Secondary	mean pressure	Indicators related to perioperative hemodynamics	Up to 5 hours including preoperative, intraoperative, and postoperative periods
Secondary	heart rate	Indicators related to perioperative hemodynamics	Up to 5 hours including preoperative, intraoperative, and postoperative periods
Secondary	pulse	Indicators related to perioperative hemodynamics	Up to 5 hours including preoperative, intraoperative, and postoperative periods
Secondary	Recovery times	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.	Up to 30 minutes after operation
Secondary	Complication	All the perioperative complications are recorded.	During the perioperative period