The Study of Ciprofol for the Suppression of Cardiovascular Responses to Tracheal Intubation

Launched by THE SECOND AFFILIATED HOSPITAL OF HAINAN MEDICAL UNIVERSITY · Oct 18, 2023

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ClinConnect Summary

This clinical trial is studying a medication called ciprofol, which is being tested to see how well it helps reduce heart-related responses during a procedure called tracheal intubation—a common technique used to help patients breathe during surgery. Researchers want to find out the right amount of ciprofol needed to safely induce general anesthesia and compare it to another medication called remimazolam. The goal is to determine if ciprofol can be a better option for patients, with fewer side effects and more comfort.

To participate in this study, you need to be between 18 and 65 years old and scheduled for surgery that requires an endotracheal tube (a tube placed in the windpipe to assist breathing). You should be in good health (ASA grade I or II) and have a body mass index (BMI) between 18 and 28. However, if you have certain health conditions, such as severe heart or lung issues, or if you're pregnant, you won't be able to join. If you take part, you can expect to receive ciprofol during your anesthesia, and the study will monitor how well it works and if it’s safe for you.

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Eligibility criteria

• 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.