The Study of Ciprofol for the Suppression of Cardiovascular Responses to Tracheal
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Heart Rate(HR)
研究概览
简要总结
Preliminary studies have illuminated the promising nature of ciprofol, indicating its enhanced safety spectrum, superior potency, and a diminished likelihood of experiencing injection-related discomfort. Venturing deeper, this research embarked on an ambitious quest to measure the 95% effective volume of ciprofol for induction of general anesthesia by a modified sequential method and juxtapose the 95% effective volume dosage of ciprofol against a corresponding dose of remimazolam during the initiation of general anesthesia. The study delved into diverse anesthetic protocols, meticulously scrutinizing the safety and efficacy credentials of ciprofol. The ultimate vision was to pave a robust foundation for the sophisticated and judicious utilization of ciprofol in clinical landscapes.
详细描述
During general anesthesia induction, tracheal intubation is a significant procedure that can cause cardiovascular fluctuations due to the stimulation of tracheal receptors. This can lead to complications such as imbalances in vital organ oxygen supply, especially in patients with cardiovascular and cerebrovascular disorders, potentially resulting in cardiac arrest. As the demand for anesthetics rises in clinical settings, some, due to extreme side effects, have been phased out, reducing the available options.
Propofol, a common anesthetic, is effective and quick but has drawbacks like injection pain and risks associated with long-term use. In contrast, ciprofol, a new class I intravenous anesthetic, is emerging as a potentially better alternative. Early research indicates that ciprofol might have a broader safety margin than propofol and offers benefits like rapid recovery and lower chances of injection pain.
Exhaustive studies on the precise dosage of ciprofol for surgical applications are scarce and comparisons between ciprofol and remimazolam are rarely reported in the literature. This research aims to bridge this knowledge gap, exploring the best dosage for tracheal intubation sedation, and ensuring patients get the most effective and safest anesthetic care.
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)
盲法说明
People who were unaware of the experiment helped to randomize the groups and inject the test drug according to the groups, and the patients who participated in the experiment as well as the doctors were unaware of the groups.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing surgery with a single-lumen endotracheal tube placed under general anesthesia;
- •American Society of Anesthesiologists(ASA grade) I or II;
- •Age 18~65 years old;
- •Body mass index (BMI) 18 to 28 kg/m2;
- •Mallampati airway classification grade I or II;
- •Acceptance of this experiment and signing of informed consent.
排除标准
- •Patients with a history of alcoholism, allergy to any component of the product;
- •Patients with severe heart, lung and brain vital organ diseases, such as acute heart attack, cerebral infarction, asthma, chronic obstructive pulmonary disease and other medical history;
- •Serious liver and kidney function abnormalities or combined serious endocrine dysfunction, such as hypertension (systolic blood pressure ≥ 160 mmHg, diastolic blood pressure ≥ 110 mmHg, HR ≥ 110 beats/min), diabetes mellitus, hyperthyroidism, hypothyroidism and so on;
- •Difficult airway (mouth opening less than 3 cross fingers, those with Mallampati score grade III or IV, difficulty in vocal valve exposure, difficulty in tracheal intubation, unsuccessful in one attempt); oropharyngeal and cervical deformities or history of previous tracheotomy;
- •Neuropsychiatric abnormalities, communication and comprehension deficits exist;
- •History of long-term sedative and analgesic medications, drug and opioid addiction, and heart rate control medications (e.g., beta blockers, alpha agonists, calcium channel blockers); and
研究组 & 干预措施
Group C
Ciprofol + sufentanil + rocuronium bromide
干预措施: Ciprofol (Drug)
Group R
Remimazolam+ sufentanil + rocuronium bromide
干预措施: Remimazolam (Drug)
结局指标
主要结局
Heart Rate(HR)
时间窗: Intravenous ciprofol up to 3 minutes after tracheal intubation
Heart rate monitored with Dash4000 equipment
Mean Arterial Pressure(MAP)
时间窗: Intravenous ciprofol up to 3 minutes after tracheal intubation
Heart rate monitored with Dash4000 equipment
次要结局
- Rate of respiratory inhibition,Injection pain,Hypotension,Allergy,Bradycardia,Muscle tremor,Postoperative nausea and vomiting(Intravenous ciprofol to leave resuscitation)
- Peripheral Oxygen Saturation(SPO2)(Intravenous ciprofol up to 3 minutes after tracheal intubation)
- Bispectral Index(BIS)(Intravenous ciprofol up to 3 minutes after tracheal intubation)