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临床试验/NCT06685198
NCT06685198尚未招募不适用

The Impact of Different Titration Endpoints of Propofol on Hemodynamics and Stress During the Induction Phase of General Anesthesia

SanQing Jin1 个研究点 分布在 1 个国家目标入组 258 人开始时间: 2025年2月20日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
258
试验地点
1
主要终点
Incidence of a 30% decrease in MAP

研究概览

简要总结

Propofol has a rapid onset and short duration of action, making it widely used for induction of general anesthesia. However, its prominent drawback is circulatory depression. Our research team previously proposed an individualized dosing method for the titration of propofol. We then compared the effects of different titration rates of propofol on hemodynamics and stress during general anesthesia induction. It was found that the incidence of hypotension during the induction period was lower in the 0.5 mg/kg/min group, with lower stress levels and faster postoperative recovery. However, this group still had a 25.3% incidence of hypotension. Therefore, we plan to further study the differences in hemodynamics, depth of anesthesia, stress response, and postoperative recovery in three groups of patients induced with a constant infusion rate of propofol at 0.5 mg/kg/min titrated to an OAA/S score of 1, an OAA/S score of 2, and BIS ≤ 60, combined with remifentanil 2 μg/kg. This study aims to explore the appropriate propofol titration endpoint during general anesthesia induction to maintain stable perioperative haemodynamics and achieve rapid postoperative recovery.

详细描述

Propofol can rapidly induce sleep in patients, creating favorable conditions for tracheal intubation, and is widely used for the induction of general anesthesia for tracheal intubation. However, its prominent drawback is circulatory depression. In clinical practice, propofol is still commonly administered for the induction of general anesthesia as a single intravenous bolus at the recommended dose (2-2.5 mg/kg). This method does not take into account individual differences and easily causes hypotension. In addition, target-controlled infusion under BIS monitoring is used in some cases. However, this approach requires high standards of equipment, has limited clinical applicability, and there is still controversy over whether the targetcontrolled model accurately reflects the concentration of propofol in blood or brain tissue.A 2020 retrospective study by Eric Y. et al. showed that the anesthetic induction dose of propofol for elderly patients was not adequately adjusted according to recommendations, resulting in an excessive actual dose. There are also studies on titrated administration of propofol, but the endpoints for titrated administration are still unclear.

Hypotension during the induction period has been identified as an independent predictor of adverse clinical outcomes. Early studies suggested that a mean arterial pressure (MAP) of <50-55 mmHg or a reduction in systolic blood pressure (SBP) or MAP by more than 40-50% from baseline can cause organ dysfunction.As research into the dangers of hypotension deepens, the minimum value that hypotension may cause damage is continuously increasing, and the harm brought by mild hypotension is increasingly being taken seriously. The impact of induced hypotension during the induction period on patients is related to the severity, duration of hypotension, and the patient's baseline condition.

Hypotension during the induction period of anesthesia is largely preventable and should be prevented. Therefore, finding appropriate endpoints for propofol titration can reduce the incidence of hypotension during the induction period, which is of ignificant significance for improving the prognosis of surgical patients.

Common methods for monitoring the depth of anesthesia during the induction period of general anesthesia include observer-based evaluations, such as the Observer's Assessment of Alertness/Sedation (OAA/S) score, and machinebased evaluations, such as the Bispectral Index (BIS) score.

The OAA/S score is a commonly used clinical observation tool that is simple and convenient to operate, requiring no additional equipment. It mainly assesses the depth of sedation by giving verbal commands and tactile stimuli to the patient. Various studies have shown that it correlates closely with machinebased indices for monitoring the depth of anesthesia, such as the BIS and the Index of Consciousness (IOC). As a straightforward, cost-effective method for monitoring the depth of anesthesia, the OAA/S score is closely related to clinical manifestations and is particularly suitable for monitoring the depth of anesthesia during the induction period.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Age 18-60 years.
  • Elective surgery with planned endotracheal intubation under general anesthesia.
  • ASA classification of I or II,with heart function classified as 1 or
  • Body Mass Index (BMI) 18-30 kg/m².

排除标准

  • Severe cardiac, pulmonary, hepatic, or renal diseases (heart function classification greater than 3 / respiratory failure / liver failure / renal failure).
  • Malignant arrhythmias: atrial flutter, atrial fibrillation, atrioventricular block, frequent ventricular premature beats, multifocal ventricular premature beats, ventricular premature beats R on T, ventricular flutter, and ventricular fibrillation.
  • Expected difficulty with intubation, hypoalbuminemia, hypertension, or diabetes mellitus.
  • Patients with a high risk of aspiration due to a full stomach, gastrointestinal obstruction, or pregnancy.
  • Patients with schizophrenia, epilepsy, Parkinson's disease, intellectual disabilities, etc.
  • Alcohol abusers or those who have been using sedatives or analgesics long-term.
  • Allergic to propofol or its emulsion.
  • Currently participating in a clinical trial that conflicts with this study.

结局指标

主要结局

Incidence of a 30% decrease in MAP

时间窗: During the procedure of anesthesia induction

Incidence of a 30% decrease in MAP during induction with three different titration endpoints

次要结局

  • Proportion of cases with MAP < 65 mmHg(During the procedure of anesthesia induction)
  • Anesthesia depth(During the procedure of anesthesia induction)
  • Tracheal intubation conditions(After finish intubation)
  • Blood glucose(During the procedure of anesthesia induction)
  • Stress hormones(During the procedure of anesthesia induction)
  • Mean Arterial Pressure(MAP)(During the procedure of anesthesia induction)
  • Heart Rate(HR)(During the procedure of anesthesia induction)
  • Cardiac Index(CI)(During the procedure of anesthesia induction)
  • Stroke Volume Index(SVI)(During the procedure of anesthesia induction)
  • Systemic Vascular Resistance Index(SVRI)(During the procedure of anesthesia induction)
  • Propofol dosage(During the procedure of anesthesia induction)
  • Induction time(After finish operation)
  • Recovery time(From surgery completion to first recovery)
  • Length of hospital stay after surgery(From surgery completion to actual hospital discharge,assessed up to 30 days)
  • Cognitive and memory function(Postoperative Day 1 and Day 30)
  • Recovery quality(Preoperative Day 1 and postoperative Day 1 and Day 30)
  • The occurrence of important cardiovascular events(Within 30 days after surgery)

研究者

发起方
SanQing Jin
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

SanQing Jin

professor

Sixth Affiliated Hospital, Sun Yat-sen University

研究点 (1)

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