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

NCT05533580 | Unknown

• 1 other identifier: 2022-TCD-1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• systolic pressure

  Up to 5 hours including preoperative, intraoperative, and postoperative periods

• diastolic pressure

  Up to 5 hours including preoperative, intraoperative, and postoperative periods

• mean pressure

  Up to 5 hours including preoperative, intraoperative, and postoperative periods

• heart rate

  Up to 5 hours including preoperative, intraoperative, and postoperative periods

• pulse

  Up to 5 hours including preoperative, intraoperative, and postoperative periods

Study Arms (2)

Remimazolam group

EXPERIMENTAL

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 %.

Drug: Remimazolam

Propofol group

ACTIVE COMPARATOR

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 %.

Drug: Propofol

Interventions

Remimazolam DRUG

The experimental group was sedated with remimazolam.

Also known as: sufentanil, cisatracurium besylate

Remimazolam group

Propofol DRUG

The control group was sedated with propofol.

Also known as: sufentanil, cisatracurium besylate

Propofol group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital of Nanchang University: lead

Study Sites (1)

the Second Affiliated Hospital of Nanchang University, Nanchang University

Nanchang, Jiangxi, China

RECRUITING

MeSH Terms

Interventions

remimazolam; Sufentanil; cisatracurium; Propofol

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Fuzhou Hua, professor

CONTACT

+8615170238929; huafuzhou@126.com

Xing Liu, Dr.

CONTACT

+8618379804346; liuxingmed@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: September 2, 2022
• First Posted: September 9, 2022
• Study Start: October 1, 2022
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: September 29, 2022

Record last verified: 2022-09

Locations

CN (1)