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

General Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05533567
• Other study ID #: 2022-EEG-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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• 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. 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.

Related Conditions & MeSH terms

• Electroencephalography
• 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	EEG waveforms	Contrasting differences in electroencephalographic oscillatory characteristics during general anesthesia with propofol and remimazolam.	Duration from the time the patient enters the operating room to the time they leave the post-anesthesia care unit, average two hours.
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