Titrated ciprofol anesthesia to prevent low blood pressure in older adults having laparoscopic abdominal surgery
Effect of Titrated Administration of Ciprofol Combined With Remifentanil on Perioperative Hypotension in Elderly Patients Undergoing Laparoscopic Abdominal Surgery: A Randomized Controlled Trial
This will test whether carefully titrated ciprofol-based anesthesia helps prevent low blood pressure during laparoscopic abdominal surgery in people aged 65 and older.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Sixth Affiliated Hospital, Sun Yat-sen University Academic / other |
| Locations | 2 sites (Guangzhou, Guangdong and 1 other locations) |
| Trial ID | NCT07328958 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial enrolls patients aged 65 and older scheduled for elective laparoscopic abdominal surgery and compares titrated ciprofol-based anesthesia to standard dosing. Anesthetic dosing will be adjusted to predefined hemodynamic endpoints with invasive arterial blood pressure monitoring to guide titration. The primary focus is intraoperative hypotension, with secondary measures including postoperative recovery outcomes. Patients with severe liver or kidney failure, uncontrolled hypertension, preoperative vasopressor needs, or major cognitive/psychiatric disorders are excluded.
Who should consider this trial
Good fit: Ideal candidates are adults aged 65 or older having elective laparoscopic abdominal surgery with ASA physical status I–III who can undergo invasive arterial blood pressure monitoring and do not have severe hepatic or renal failure.
Not a fit: Patients with severe hepatic or renal failure, uncontrolled severe hypertension, a need for continuous vasopressor support before surgery, or certain severe psychiatric or neurological conditions are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, the approach could reduce episodes of intraoperative hypotension and improve early postoperative recovery in older surgical patients.
How similar studies have performed: Prior studies indicate ciprofol produces less hemodynamic suppression than older agents like propofol, but randomized evidence on a titrated ciprofol approach in frail elderly surgical patients is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥65 years, scheduled for elective laparoscopic abdominal surgery * American Society of Anesthesiologists (ASA) physical status I-III * Requirement for invasive arterial blood pressure monitoring Exclusion Criteria: * Participation in other clinical trials that may interfere with the intervention or outcomes of this study * Severe hepatic or renal disease (GFR ≤30 mL/min/1.73 m², requirement for renal replacement therapy, or Child-Pugh class C liver function) * Uncontrolled severe hypertension (preoperative SBP ≥180 mmHg or DBP ≥110 mmHg) * Patients with severe mental disorders (such as schizophrenia), epilepsy, or Parkinson's disease, severe cognitive or intellectual impairment, severe visual or hearing impairments affecting assessment, or long-term alcohol abuse or use of sedative/analgesic medications; * Known allergy to drugs used in this study * Requirement for continuous vasopressor infusion before surgery, or intraoperative need for prolonged hemodynamic manipulation due to surgical factors * Anticipated blood loss \>15% of estimated blood volume * Expected surgical duration \<1 hours or \>6 hours * Expected postoperative hospital stay \<72 hours
Where this trial is running
Guangzhou, Guangdong and 1 other locations
- Sixth Affiliated Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (Not_yet_recruiting)
- Sixth Affiliated Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Hong Bai, Doctoral student
- Email: bhong@mail.sysu.edu.cn
- Phone: +86 13480250519
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.