Electroencephalographic Profiles During General Anesthesia: a Comparative Study of Remimazolam and Propofol

NCT ID: NCT05533567

Last Updated: 2022-09-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2023-01-31

Brief Summary

How anesthetic drugs induce and maintain the behavioral state of general anesthesia is an important question in medicine and neuroscience. Different anesthetic drugs act on different molecular targets and neural circuit mechanisms, exhibiting drug-specific EEG features. 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. This study aimed to investigate the differences in the characteristics of EEG oscillations during general anesthesia by comparing propofol and remimazolam.

Conditions

General Anesthesia; Electroencephalography; Laparoscopic Cholecystectomy; Remimazolam; Propofol

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. Right-handed, age 18-60 years, sex not limited.

2. Patients proposed to undergo elective laparoscopic cholecystectomy under general anesthesia in the morning, with an expected operative duration of approximately 1h to 2h.

3. Body mass index (BMI) <28 kg/m2.

4. Anxiety score >50, both without anxiety and sleep disorders.

5. ASA anesthesia classification grade I with Mallampati class I airway anatomy.

6. Can communicate effectively with the physician.

7. Patients were aware of and voluntarily signed the informed consent form.

Exclusion Criteria

1. Relative contraindications to general anesthesia: patients with severe cardiac or pulmonary function disease.

2. Patients taking drugs that may confound EEG or behavioral findings or during pregnancy.

3. Patients with a history of psychiatric or neurological disorders, drug abuse, or drug addiction.

4. Any cerebrovascular accident within 3 months, such as stroke, transient ischemic attack (TIA), etc.;

5. Inability to cooperate in completing the test, or refusal of the patient or family members to participate.

6. 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

Danying Yang, Dr.

Role: CONTACT

yangdanying0315@126.com

+8615270435219

Facility Contacts

Fuzhou Hua, professor

Role: primary

huafuzhou@126.com

+8615170238929

Other Identifiers

2022-EEG-1

Identifier Type: -

Identifier Source: org_study_id