Intubation, Intratracheal Clinical Trial
Official title:
The Study of Ciprofol for the Suppression of Cardiovascular Responses to Tracheal
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.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | December 30, 2023 |
Est. primary completion date | December 30, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: 1. Patients undergoing surgery with a single-lumen endotracheal tube placed under general anesthesia; 2. American Society of Anesthesiologists(ASA grade) I or II; 3. Age 18~65 years old; 4. Body mass index (BMI) 18 to 28 kg/m2; 5. Mallampati airway classification grade I or II; 6. Acceptance of this experiment and signing of informed consent. Exclusion Criteria: 1. Patients with a history of alcoholism, allergy to any component of the product; 2. 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; 3. 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; 4. 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; 5. Neuropsychiatric abnormalities, communication and comprehension deficits exist; 6. 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 7. Pregnancy. |
Country | Name | City | State |
---|---|---|---|
China | The Second Affiliated Hospital of Hainan Medical University, Hai Kou, China | Haikou | Hainan |
Lead Sponsor | Collaborator |
---|---|
The Second Affiliated Hospital of Hainan Medical University |
China,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Heart Rate(HR) | Heart rate monitored with Dash4000 equipment | Intravenous ciprofol up to 3 minutes after tracheal intubation | |
Primary | Mean Arterial Pressure(MAP) | Heart rate monitored with Dash4000 equipment | Intravenous ciprofol up to 3 minutes after tracheal intubation | |
Secondary | Bispectral Index(BIS) | Monitored woth Bispectral Index Vista. BIS ranges from 0-100, with 100 representing full wakefulness and 0 representing complete cortical electroencephalogram(EEG) suppression; the smaller the value, the deeper the depth of sedation Mild sedation is BIS 65-85, and deep sedation is BIS 40-60, with primitive EEG bursts of suppression when BIS < 40. | Intravenous ciprofol up to 3 minutes after tracheal intubation | |
Secondary | Peripheral Oxygen Saturation(SPO2) | Monitored with Dash4000 equipment | Intravenous ciprofol up to 3 minutes after tracheal intubation | |
Secondary | Rate of respiratory inhibition,Injection pain,Hypotension,Allergy,Bradycardia,Muscle tremor,Postoperative nausea and vomiting | Referring to the standards in ciprofol's Phase III trial, the adverse reactions were defined as follows: (1) hypoxemia (oxygen saturation < 90% for > 30 s); (2) bradycardia (HR < 45/min for > 30 s); (3) hypotension (systolic BP decreased by 30% from the baseline value for > 2 min); and (4) pain at the injection site during ciprofol administration, evaluated by a study-blinded investigator using a 4-point verbal rating scale. | Intravenous ciprofol to leave resuscitation |
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