Using ciprofol to induce loss of consciousness in elderly patients
Ciprofol EC50 for Inducing Loss of Consciousness in Elderly Patients: an Exploratory Study Based on Dixon's Up-and-Down Method
This study tests the best dose of a new sedative called ciprofol to safely help older patients fall asleep during surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 65 Years to 105 Years |
| Sex | All |
| Sponsor | Zhejiang Cancer Hospital Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06253078 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the optimal dosage of ciprofol, a novel sedative, for inducing general anesthesia in elderly patients aged 65 and above. The study aims to determine the appropriate dosage based on different age brackets within this population, as ciprofol has shown a higher affinity for GABA A receptors and fewer side effects compared to traditional anesthetics like propofol. A total of 150 patients will be monitored for loss of consciousness after receiving varying doses of ciprofol, with evaluations conducted within four minutes of administration. The trial is designed to enhance the safety and efficacy of anesthesia in older adults undergoing surgery.
Who should consider this trial
Good fit: Ideal candidates are elderly patients aged 65 years and older, classified as ASA physical status I or II, who are undergoing non-cardiac surgery.
Not a fit: Patients with ASA class III or higher, those with allergies to anesthetic solutions, or individuals with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer and more effective anesthesia protocols for elderly patients, reducing the risk of side effects.
How similar studies have performed: While ciprofol is a newer agent, previous studies have indicated its effectiveness in anesthesia induction, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 65 ≤ age years; * ASA physical state I and II; * Hadn't a history of allergy to the drugs used in this study; Exclusion Criteria: * America Society of Anesthesiologists (ASA) class \>III; * Allergic to anesthetic solutions or the drugs used in this study; * Body mass index (BMI) ≤ 20 or ≥ 30 kg/m2; * Using hypnotics, opioid analgesics, or anti-anxiety medications; * Known or suspected heart failure (ejection fraction \<40%), severe respiratory disease, renal or metabolic disease * Refuse to participate or participate with other clinical investigators ;
Where this trial is running
Hangzhou, Zhejiang
- Jiangling Wang — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Xiaochun Jin
- Email: ec@zjcc.org.cn
- Phone: +8657188122564
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.