Effects of Subanesthetic Dose of Esketamine on Hemodynamic Stability and Postoperative Recovery Quality in Elderly Thoracic Surgery Patients Under General Anesthesia: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- Maximum Decrease in Mean Arterial Pressure (MAP) During Anesthesia Induction
研究概览
简要总结
This retrospective study evaluated the effects of a subanesthetic dose of esketamine (0.25 mg/kg) on intraoperative hemodynamic stability and postoperative recovery quality in elderly patients (aged 65-75) undergoing thoracic surgery under general anesthesia. A total of 230 patients were included and randomly assigned to receive either esketamine or placebo during anesthesia induction. Key outcomes included blood pressure and heart rate stability, catecholamine levels, recovery time, incidence of adverse events such as delirium or nausea, and opioid use.
详细描述
Elderly patients are at increased risk for anesthesia-related complications due to reduced physiological reserves and comorbidities. Thoracic surgery further increases this risk by inducing significant cardiovascular and sympathetic stress. Esketamine, the S-enantiomer of ketamine, possesses sympathomimetic and analgesic properties that may help stabilize circulation and reduce postoperative complications when used at subanesthetic doses.
In this single-center, randomized controlled trial, patients aged 65-75 scheduled for elective thoracic surgery were administered either 0.25 mg/kg esketamine or normal saline during anesthesia induction. Hemodynamic parameters (mean arterial pressure, heart rate), plasma catecholamine concentrations (norepinephrine, epinephrine), and adverse cardiovascular responses were recorded. Postoperative outcomes included emergence time, PACU stay, incidence of delirium, hallucinations, nausea and vomiting, and opioid consumption.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 75 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 65-75 years
- •Scheduled for elective thoracic surgery (e.g., lobectomy, bullectomy)
- •ASA physical status I-III
- •Adequate cardiopulmonary function
- •Able to provide informed consent
- •Preoperative systolic blood pressure <160 mmHg with stable control
- •No cognitive impairment
排除标准
- •Severe cardiovascular disease (e.g., unstable angina, heart failure ≥ NYHA class III)
- •History of cerebrovascular disease
- •Uncontrolled hypertension (SBP >180 mmHg)
- •Severe hepatic or renal dysfunction
- •Chronic psychiatric illness or long-term CNS-active drug use
- •Allergy to ketamine or its derivatives
- •Elevated intracranial or intraocular pressure
- •Use of monoamine oxidase inhibitors within 24 hours before surgery
- •History of substance abuse
研究组 & 干预措施
Esketamine Group
Participants in this group received a subanesthetic dose of esketamine (0.25 mg/kg) intravenously during induction of general anesthesia. The esketamine was administered slowly over approximately 30 seconds after midazolam and sufentanil, and prior to propofol and rocuronium. Standard anesthesia induction and maintenance protocols were followed thereafter.
干预措施: Esketamine (Drug)
Esketamine Group
Participants in this group received a subanesthetic dose of esketamine (0.25 mg/kg) intravenously during induction of general anesthesia. The esketamine was administered slowly over approximately 30 seconds after midazolam and sufentanil, and prior to propofol and rocuronium. Standard anesthesia induction and maintenance protocols were followed thereafter.
干预措施: Midazolam (Drug)
Esketamine Group
Participants in this group received a subanesthetic dose of esketamine (0.25 mg/kg) intravenously during induction of general anesthesia. The esketamine was administered slowly over approximately 30 seconds after midazolam and sufentanil, and prior to propofol and rocuronium. Standard anesthesia induction and maintenance protocols were followed thereafter.
干预措施: Sufentanil (Drug)
Esketamine Group
Participants in this group received a subanesthetic dose of esketamine (0.25 mg/kg) intravenously during induction of general anesthesia. The esketamine was administered slowly over approximately 30 seconds after midazolam and sufentanil, and prior to propofol and rocuronium. Standard anesthesia induction and maintenance protocols were followed thereafter.
干预措施: propofol (Drug)
Esketamine Group
Participants in this group received a subanesthetic dose of esketamine (0.25 mg/kg) intravenously during induction of general anesthesia. The esketamine was administered slowly over approximately 30 seconds after midazolam and sufentanil, and prior to propofol and rocuronium. Standard anesthesia induction and maintenance protocols were followed thereafter.
干预措施: Rocuronium (Drug)
Control Group
Participants in this group received an equivalent volume of 0.9% normal saline intravenously during induction of general anesthesia, administered in the same manner and time frame as in the esketamine group. The saline was administered after midazolam and sufentanil, and prior to propofol and rocuronium. All other aspects of anesthesia management were identical to the esketamine group.
干预措施: Normal Saline (0.9% Sodium Chloride) (Drug)
Control Group
Participants in this group received an equivalent volume of 0.9% normal saline intravenously during induction of general anesthesia, administered in the same manner and time frame as in the esketamine group. The saline was administered after midazolam and sufentanil, and prior to propofol and rocuronium. All other aspects of anesthesia management were identical to the esketamine group.
干预措施: Midazolam (Drug)
Control Group
Participants in this group received an equivalent volume of 0.9% normal saline intravenously during induction of general anesthesia, administered in the same manner and time frame as in the esketamine group. The saline was administered after midazolam and sufentanil, and prior to propofol and rocuronium. All other aspects of anesthesia management were identical to the esketamine group.
干预措施: Sufentanil (Drug)
Control Group
Participants in this group received an equivalent volume of 0.9% normal saline intravenously during induction of general anesthesia, administered in the same manner and time frame as in the esketamine group. The saline was administered after midazolam and sufentanil, and prior to propofol and rocuronium. All other aspects of anesthesia management were identical to the esketamine group.
干预措施: propofol (Drug)
Control Group
Participants in this group received an equivalent volume of 0.9% normal saline intravenously during induction of general anesthesia, administered in the same manner and time frame as in the esketamine group. The saline was administered after midazolam and sufentanil, and prior to propofol and rocuronium. All other aspects of anesthesia management were identical to the esketamine group.
干预措施: Rocuronium (Drug)
结局指标
主要结局
Maximum Decrease in Mean Arterial Pressure (MAP) During Anesthesia Induction
时间窗: From anesthesia induction to skin incision (approximately 15 minutes)
The lowest value of MAP recorded between the time of anesthesia induction and skin incision, compared to baseline MAP before induction. This outcome evaluates the degree of hemodynamic depression associated with induction agents and the protective effect of esketamine.
次要结局
- Time to Eye Opening After Surgery(Postoperative period in PACU (within 30 minutes after surgery))
- Incidence of Hypotension During Anesthesia Induction(From anesthesia induction to intubation (approximately 5 minutes))
- Incidence of Postoperative Delirium(From PACU admission to hospital discharge (up to 24 hours postoperatively))
- Postoperative Morphine Requirement(Within 1 hour after surgery in PACU)