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

NCT ID: NCT05533580

Last Updated: 2022-09-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2023-01-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Remimazolam group

1. Induction of anesthesia Slowly injects remimazolam 0.4-0.6 mg/kg (about 1 minute) until loss of consciousness (LoC), if the degree of sedation is insufficient, additional remimazolam (0.05 mg/kg each time) is allowed. After the LoC, intravenous sufentanil 0.3 ~0.5ug/kg and cisatracurium besylate 0.1 mg/kg are injected intravenously. After the muscles are sufficiently relaxed and blood circulation is stable, the tracheal tube is inserted under a glide scope.

2. Maintenance of anesthesia remimazolam 0.4~1.2 mg/kg/h and remifentanil 0.1~0.3 ug/kg/min are injected intravenously to maintain sedation and assistant analgesia, and cisatracurium besylate 0.02 mg/kg is allowed to add as appropriate. During the operation, the dose of anesthetic drugs is adjusted so that the fluctuation of heart rate and blood pressure did not exceed 10 %.

Group Type: EXPERIMENTAL

Remimazolam

Intervention Type: DRUG

The experimental group was sedated with remimazolam.

Propofol group

1. Induction of anesthesia Slowly injects propofol 2-4 mg/kg (about 1 min) until loss of consciousness (LoC), allowing additional propofol (0.5 mg/kg each time) if sedation is insufficient. after LoC, intravenous sufentanil 0.3 ~0.5ug/kg and cisatracurium besylate 0.1 mg/kg. after sufficient muscle relaxation and blood circulation stabilization, the tracheal tube was inserted under the sliding scope.

2. Maintenance of anesthesia propofol 4~10mg/kg/h and remifentanil 0.1~0.3 ug/kg/min are injected intravenously to maintain sedation and assistant analgesia, and cisatracurium besylate 0.02 mg/kg is allowed to add as appropriate. During the operation, the dose of anesthetic drugs is adjusted so that the fluctuation of heart rate and blood pressure did not exceed 10 %.

Group Type: ACTIVE_COMPARATOR

Propofol

Intervention Type: DRUG

The control group was sedated with propofol.

Interventions

Remimazolam

The experimental group was sedated with remimazolam.

Intervention Type: DRUG

Propofol

The control group was sedated with propofol.

Intervention Type: DRUG

Other Intervention Names

sufentanil; cisatracurium besylate; sufentanil; cisatracurium besylate

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital of Nanchang University

OTHER

Sponsor Role: lead

Responsible Party

Fuzhou Hua

Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

the Second Affiliated Hospital of Nanchang University, Nanchang University

Nanchang, Jiangxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Fuzhou Hua, professor

Role: CONTACT

huafuzhou@126.com

+8615170238929

Xing Liu, Dr.

Role: CONTACT

liuxingmed@163.com

+8618379804346

Facility Contacts

Fuzhou Hua, professor

Role: primary

huafuzhou@126.com

+8615170238929

Other Identifiers

2022-TCD-1

Identifier Type: -

Identifier Source: org_study_id