Using Ciprofol to Reduce Low Blood Pressure in Elderly Patients During Anesthesia
A Prospective Randomized Controlled Trail of Ciprofol Titrated Induction in Reducing Post-induction Hypotension in Geriatric Patients Under General Anesthesia
This study is testing if a new anesthetic called Ciprofol can help prevent low blood pressure in older patients during surgery compared to the standard anesthetic, propofol.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 65 Years to 90 Years |
| Sex | All |
| Sponsor | Sixth Affiliated Hospital, Sun Yat-sen University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06258967 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of Ciprofol, a novel anesthetic, to reduce the incidence of hypotension in elderly patients during the induction phase of general anesthesia. It compares the effects of Ciprofol and propofol, focusing on hypotension rates, agitation during recovery, perioperative awareness, and postoperative delirium. The study aims to establish a safer anesthesia protocol for geriatric patients by employing titrated anesthesia techniques. A total of 160 patients aged 65 to 90 will be enrolled to assess the outcomes of both anesthetic agents.
Who should consider this trial
Good fit: Ideal candidates for this study are elderly patients aged 65 to 90 scheduled for elective surgeries requiring general anesthesia.
Not a fit: Patients with severe comorbidities, such as uncontrolled hypertension or significant liver and kidney disease, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the safety and recovery experience for elderly patients undergoing surgery.
How similar studies have performed: While the use of titrated anesthesia is established, the specific application of Ciprofol in this context is novel and has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 65 years and age \< 90 years. * ASA (American Society of Anesthesiologists) physical status classification 1-3. * Scheduled for elective general anesthesia surgery. Exclusion Criteria: * Participants already enrolled in other studies or those already assigned in this study . * BMI (Body Mass Index) ≤ 18 or ≥ 30 kg/m2. * Preoperative assessment indicating a challenging airway or a risk of aspiration, requiring a slow induction for intubation. * Presence of severe liver or kidney disease (GFR ≤ 30 ml/min/1.73m2 or requiring renal replacement therapy; Child-Pugh class C for liver function). * Patients with severe uncontrolled hypertension (preoperative SBP ≥ 180 mmHg or DBP ≥ 110 mmHg). * Individuals with arrhythmias and severe valvular diseases, including high-degree atrioventricular block (Mobitz type II or third-degree block); symptomatic bradycardia; symptomatic ventricular arrhythmias; prolonged Q-T interval; supraventricular arrhythmias combined with an uncontrolled ventricular rate \> 100 bpm (at rest); new-onset ventricular tachycardia; uncontrolled atrial fibrillation (ventricular rate ≥ 110 bpm); atrial flutter; severe aortic valve stenosis (mean pressure gradient \> 40 mmHg; valve area \< 1 cm2; symptomatic); severe mitral valve stenosis (progressive breathlessness during exertion; exertional syncope; heart failure). * Patients diagnosed with schizophrenia, epilepsy, Parkinson's disease, severe cognitive impairment, intellectual disability, hearing impairment. * Individuals with a history of alcoholism or long-term use of sedatives and analgesics. * Previous allergic reactions to medications used in this study. * Individuals already under vasoconstrictor treatment before anesthesia induction.
Where this trial is running
Guangzhou, Guangdong
- the Sixth Affiliated Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
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.