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

Phase 4

Recruiting

• Conditions: Intubation, Intratracheal; Adverse Effects
• Interventions: Drug: Ciprofol; Drug: Remimazolam

• Registration Number: NCT06095570
• Lead Sponsor: The Second Affiliated Hospital of Hainan Medical University

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.

Study Timeline

• Study Start: 2022-07-23
• Status Verified: 2023-09
• Study First Submitted: 2023-09-30
• Study First Submitted QC: 2023-10-18
• Last Update Submitted: 2023-10-18
• Study First Posted: 2023-10-23
• Last Update Posted: 2023-10-23
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group C	Ciprofol	Ciprofol + sufentanil + rocuronium bromide
Group R	Remimazolam	Remimazolam+ sufentanil + rocuronium bromide

Primary Outcome Measures

Name	Time	Method
Heart Rate(HR)	Intravenous ciprofol up to 3 minutes after tracheal intubation	Heart rate monitored with Dash4000 equipment
Mean Arterial Pressure(MAP)	Intravenous ciprofol up to 3 minutes after tracheal intubation	Heart rate monitored with Dash4000 equipment

Secondary Outcome Measures

Name	Time	Method
Rate of respiratory inhibition,Injection pain,Hypotension,Allergy,Bradycardia,Muscle tremor,Postoperative nausea and vomiting	Intravenous ciprofol to leave resuscitation	Referring to the standards in ciprofol's Phase III trial, the adverse reactions were defined as follows: (1) hypoxemia (oxygen saturation \< 90% for \> 30 s); (2) bradycardia (HR \< 45/min for \> 30 s); (3) hypotension (systolic BP decreased by 30% from the baseline value for \> 2 min); and (4) pain at the injection site during ciprofol administration, evaluated by a study-blinded investigator using a 4-point verbal rating scale.
Peripheral Oxygen Saturation(SPO2)	Intravenous ciprofol up to 3 minutes after tracheal intubation	Monitored with Dash4000 equipment
Bispectral Index(BIS)	Intravenous ciprofol up to 3 minutes after tracheal intubation	Monitored woth Bispectral Index Vista. BIS ranges from 0-100, with 100 representing full wakefulness and 0 representing complete cortical electroencephalogram(EEG) suppression; the smaller the value, the deeper the depth of sedation Mild sedation is BIS 65-85, and deep sedation is BIS 40-60, with primitive EEG bursts of suppression when BIS \< 40.

Trial Locations

Locations (1)

The Second Affiliated Hospital of Hainan Medical University, Hai Kou, China; 🇨🇳 Haikou, Hainan, China