Status:
UNKNOWN
The Study of Ciprofol for the Suppression of Cardiovascular Responses to Tracheal Intubation
Lead Sponsor:
The Second Affiliated Hospital of Hainan Medical University
Conditions:
Intubation, Intratracheal
Adverse Effects
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
Preliminary studies have illuminated the promising nature of ciprofol, indicating its enhanced safety spectrum, superior potency, and a diminished likelihood of experiencing injection-related discomfo...
Detailed Description
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 complicati...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
- Pregnancy.
Key Trial Info
Start Date :
July 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2023
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06095570
Start Date
July 23 2022
End Date
December 30 2023
Last Update
October 23 2023
Active Locations (1)
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1
The Second Affiliated Hospital of Hainan Medical University, Hai Kou, China
Haikou, Hainan, China, 570311