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临床试验/NCT07468162
NCT07468162尚未招募不适用

Analysis of the Characteristic Electroencephalogram of Patients Undergoing Orthopedic Surgery During the Induction of General Anesthesia and the Unconscious State and Recovery Period With Electroencephalogram Monitoring Device

First Affiliated Hospital of Zhejiang University0 个研究点目标入组 48 人开始时间: 2026年3月20日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
48
主要终点
Electroencephalogram changes during the perioperative period

研究概览

简要总结

Patients were enrolled according to predefined inclusion and exclusion criteria. Following surgical admission, standard monitoring was initiated, including continuous assessment of heart rate, blood pressure, electrocardiogram (ECG), and peripheral capillary oxygen saturation (SpO₂). A peripheral intravenous line was established. Bispectral index (BIS) monitoring was performed continuously using a BIS monitor to assess frontal lobe electroencephalographic activity. Based on the type of surgical procedure, regional nerve block was administered. Upon confirmation of adequate block efficacy, patients were assigned to treatment groups according to sealed envelope randomization, and corresponding intravenous sedative regimens were initiated. Sedative induction agents were administered as follows: Group A received remimazolam at 0.08 mg/kg; Group B received dexmedetomidine at 1 μg/kg over 10 minutes; Group C received midazolam at 0.05 mg/kg. Maintenance infusions were as follows: Group A received remimazolam at 1 mg/kg·h; Group B received dexmedetomidine at 0.2-0.7 μg/kg·h; for Group C, if consciousness was not sufficiently suppressed with the initial dose, midazolam was supplemented in increments of 0.01 mg/kg, not exceeding a total dose of 0.1 mg/kg. Following induction, sedation depth was assessed every 2 minutes using the Observer's Assessment of Alertness/Sedation (OAA/S) scale, with auditory stimulation applied every 30 seconds until the patient no longer responded. The time to loss of response to auditory stimuli and the time to loss of consciousness were recorded. Surgical intervention was then performed. Ten minutes prior to anticipated completion of surgery, sedative infusion was discontinued. Sedation depth was reassessed every 2 minutes using the OAA/S scale, with repeated auditory stimulation every 30 seconds to determine the time to return of response and time to recovery of consciousness. If the patient had not achieved an OAA/S score of 5 within 30 minutes after discontinuation of sedation, flumazenil was administered as a reversal agent. Once the OAA/S score reached 5 or spontaneous responses to auditory stimuli were observed-indicating transition back to a responsive state-and complete electroencephalographic data had been collected, no further intervention was required.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age: 20 - 60 years old. BMI: 18 ≤ BMI ≤ 24 kg/m
  • Right-handed. ASA classification: I - II. Patients scheduled for extremity surgery of upper and lower limbs and undergoing nerve block, those who understand and sign the informed consent form, and those receiving non-endotracheal general anesthesia with remimazolam or dexmedetomidine or midazolam, with Mallampati classification: I - II.

排除标准

  • Skin infection at the site of nerve block puncture; history of smoking and alcohol abuse, history of brain surgery, history of cerebral infarction, mental and neurological disorders (MMSE < 18, 3D-CAM positive), history of taking any psychotropic or opioid drugs within 2 weeks, hearing impairment, cardiovascular disease, expected difficulty in airway management or sleep apnea syndrome, drug (including those with a history of allergic reaction to the test drug or contraindications for use) or food allergies, pregnant or lactating patients, patients or family members who refuse to participate, and those who refuse to undergo nerve block.

研究组 & 干预措施

sedation of remimazolam

Electroencephalogram changes under moderate deep sedation induced by remimazolam

干预措施: After the use of sedative drugs, the changes in the electroencephalogram (EEG) spectrum were observed with an EEG monitor (Other)

sedation of dexmedetomidine

Electroencephalogram changes under moderate deep sedation induced by dexmedetomidine

干预措施: After the use of sedative drugs, the changes in the electroencephalogram (EEG) spectrum were observed with an EEG monitor (Other)

sedation of midazolam

Electroencephalogram changes under moderate deep sedation induced by midazolam

干预措施: After the use of sedative drugs, the changes in the electroencephalogram (EEG) spectrum were observed with an EEG monitor (Other)

结局指标

主要结局

Electroencephalogram changes during the perioperative period

时间窗: From the date of random grouping until the end of the surgery

Power changes in α and β bands of electroencephalogram during the perioperative period

次要结局

未报告次要终点

研究者

发起方
First Affiliated Hospital of Zhejiang University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhu Weiliu

Principal Investigator

First Affiliated Hospital of Zhejiang University

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