Using ciprofol to reduce heart issues during tracheal intubation

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

This study is testing if a new anesthetic called ciprofol can help reduce heart problems during tracheal intubation in patients having surgery, compared to another anesthetic called remimazolam.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: The Second Affiliated Hospital of Hainan Medical University (Academic / other)
• Locations: 1 site (Haikou, Hainan)
• Trial ID: NCT06095570 on ClinicalTrials.gov

What this trial studies

This research investigates the use of ciprofol, a new intravenous anesthetic, to minimize cardiovascular responses during tracheal intubation in patients undergoing surgery. The study compares the effective dosage of ciprofol against remimazolam, focusing on safety and efficacy during general anesthesia induction. By examining various anesthetic protocols, the research aims to establish a solid foundation for the clinical use of ciprofol, potentially offering a safer alternative to traditional anesthetics like propofol. The ultimate goal is to enhance patient safety and comfort during surgical procedures.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with a BMI between 18 and 28, undergoing surgery requiring general anesthesia.

Not a fit: Patients with severe cardiovascular, respiratory, or neurological conditions, as well as those with a history of substance abuse or significant organ dysfunction, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safer anesthetic option that reduces cardiovascular complications during intubation.

How similar studies have performed: While there is limited literature comparing ciprofol and remimazolam, preliminary studies suggest ciprofol may offer advantages over traditional anesthetics, indicating potential for success.

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.

Where this trial is running

Haikou, Hainan

• The Second Affiliated Hospital of Hainan Medical University, Hai Kou, China — Haikou, Hainan, China (Recruiting)

Study contacts

• Principal investigator: Xiaoru Wu — The Second Affiliated Hospital of Hainan Medical University, Hai Kou, China
• Study coordinator: Hu Sun

Conditions Intubation, Intratracheal; Adverse Effects