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

Hainan Medical University

Status and phase: Enrolling; Phase 4

Conditions: Adverse Effects; Intubation, Intratracheal

Treatments: Drug: Ciprofol; Drug: Remimazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT06095570

RM20220701

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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150 participants in 2 patient groups

Group C

Experimental group

Description:

Ciprofol + sufentanil + rocuronium bromide

Treatment:

Drug: Ciprofol

Group R

Active Comparator group

Description:

Remimazolam+ sufentanil + rocuronium bromide

Treatment:

Drug: Remimazolam