Clinical trial NCT06095570: The Study of Ciprofol for the Suppression of Cardiovascular Responses to Tracheal Intubation
Official title: The Study of Ciprofol for the Suppression of Cardiovascular Responses to Tracheal
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Intubation, Intratracheal
Adverse Effects
Lead sponsor: The Second Affiliated Hospital of Hainan Medical University
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group C: Ciprofol + sufentanil + rocuronium bromide Group R: Remimazolam+ sufentanil + rocuronium bromide
Primary purpose: TREATMENT

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 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.

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 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.

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.

Primary outcomes:
measure: Heart Rate(HR)
timeFrame: Intravenous ciprofol up to 3 minutes after tracheal intubation
measure: Mean Arterial Pressure(MAP)
timeFrame: Intravenous ciprofol up to 3 minutes after tracheal intubation
Secondary outcomes:
measure: Bispectral Index(BIS)
timeFrame: Intravenous ciprofol up to 3 minutes after tracheal intubation
measure: Peripheral Oxygen Saturation(SPO2)
timeFrame: Intravenous ciprofol up to 3 minutes after tracheal intubation
measure: Rate of respiratory inhibition,Injection pain,Hypotension,Allergy,Bradycardia,Muscle tremor,Postoperative nausea and vomiting
timeFrame: Intravenous ciprofol to leave resuscitation
Other outcomes:
Locations:
city: Haikou
country: China
facility: The Second Affiliated Hospital of Hainan Medical University, Hai Kou, China
state: Hainan
Study officials:
affiliation: The Second Affiliated Hospital of Hainan Medical University, Hai Kou, China
name: Hu Sun
role: STUDY_CHAIR
affiliation: The Second Affiliated Hospital of Hainan Medical University, Hai Kou, China
name: Min Liao
role: STUDY_DIRECTOR
affiliation: The Second Affiliated Hospital of Hainan Medical University, Hai Kou, China
name: Xiaoru Wu
role: PRINCIPAL_INVESTIGATOR
affiliation: The Second Affiliated Hospital of Hainan Medical University, Hai Kou, China
name: Jianing Hu
role: PRINCIPAL_INVESTIGATOR
affiliation: The Second Affiliated Hospital of Hainan Medical University, Hai Kou, China
name: Xingzhou Lin
role: PRINCIPAL_INVESTIGATOR
affiliation: West China Hospital
name: Tangyuanmeng Zhao
role: PRINCIPAL_INVESTIGATOR
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