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

Sponsor

Second Affiliated Hospital of Nanchang University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05533580

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
General Anesthesia Laparoscopic Cholecystectomy Remimazolam Propofol Dynamic Cerebral Autoregulation	Drug: Remimazolam Drug: Propofol	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Differential Effects of Remimazolam and Propofol on Dynamic Cerebral

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Jan 31, 2023

Anticipated Study Completion Date :

Jan 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Remimazolam group 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. 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 %.	Drug: Remimazolam The experimental group was sedated with remimazolam. Other Names: sufentanil cisatracurium besylate
Active Comparator: Propofol group 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. 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 %.	Drug: Propofol The control group was sedated with propofol. Other Names: sufentanil cisatracurium besylate

Arm

Intervention/Treatment

Experimental: Remimazolam group

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. 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 %.

Drug: Remimazolam

The experimental group was sedated with remimazolam.

Other Names:

sufentanil

cisatracurium besylate

Active Comparator: Propofol group

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. 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 %.

Drug: Propofol

The control group was sedated with propofol.

Other Names:

sufentanil

cisatracurium besylate

Outcome Measures

Primary Outcome Measures

Differences in dynamic cerebral blood flow autoregulation [From 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 Outcome Measures

systolic pressure [Up to 5 hours including preoperative, intraoperative, and postoperative periods]
Indicators related to perioperative hemodynamics
diastolic pressure [Up to 5 hours including preoperative, intraoperative, and postoperative periods]
Indicators related to perioperative hemodynamics
mean pressure [Up to 5 hours including preoperative, intraoperative, and postoperative periods]
Indicators related to perioperative hemodynamics
heart rate [Up to 5 hours including preoperative, intraoperative, and postoperative periods]
Indicators related to perioperative hemodynamics
pulse [Up to 5 hours including preoperative, intraoperative, and postoperative periods]
Indicators related to perioperative hemodynamics
Recovery times [Up to 30 minutes after operation]
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.
Complication [During the perioperative period]
All the perioperative complications are recorded.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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