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RecruitingPhase 4NCT06952608

Effect of Ciprofol on Intraoperative Hypotension in Elderly Patients Receiving Renin-angiotensin System Inhibitors

The Effect of Ciprofol on Intraoperative Hypotension in Elderly Patients Receiving Renin-angiotensin System Inhibitors: a Prospective, Randomized Controlled Trial

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

140 participants

Start Date

Apr 10, 2025

Study Type

INTERVENTIONAL

Summary

The prevention of intraoperative hypotension could reduce postoperative organ injury and mortality, particularly in elderly patients receiving long-term renin-angiotensin system inhibitors. Previous meta-analyses suggest that ciprofol, a novel intravenous anesthetic agent, may provide improved hemodynamic stability compared to propofol; however, its precise effects on perioperative hemodynamics remain unclear. The study will assess whether ciprofol improves perioperative hemodynamic stability in elderly patients receiving renin-angiotensin system inhibitors.

Eligibility

Min Age: 65 Years

Inclusion Criteria6

  • Patients undergoing elective abdominal surgery under general anesthesia
  • Duration of surgery exceeding 2 hours
  • Patients receiving long-term renin-angiotensin system inhibitor therapy (>3 months prior to surgery)
  • Age ≥ 65 years
  • ASA classification II-III
  • Informed consent was obtained from patients or their guardians

Exclusion Criteria11

  • History of allergy to opioids, propofol, or ciprofol components.
  • Anticipated difficult airway (limited mouth opening, restricted neck movement, or modified Mallampati grade III-IV) or difficult mask ventilation.
  • Body mass index ≤18 or ≥35 kg/m².
  • Severe hepatic dysfunction (total bilirubin ≥3.0 mg/dL or AST/ALT ≥2 times the upper limit of normal).
  • Severe renal impairment (creatinine clearance ≤30 mL/min).
  • Cardiac diseases (AV block higher than first-degree, heart rate <50 bpm, severe arrhythmias, severe valvular heart disease, heart failure, or unstable angina on the day of surgery).
  • Preoperative cognitive impairment, cerebrovascular disease, or history of psychiatric illness.
  • Abnormal thyroid-stimulating hormone levels or history of thyroid replacement therapy.
  • Unstable asthma or history of asthma.
  • Alcohol abuse, drug abuse, chronic opioid dependence, or analgesic use exceeding 3 months.
  • Lactating or pregnant women.

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Interventions

DRUGCiprofol group

General anesthesia induction and maintenance were performed using ciprofol.

DRUGPropofol group

General anesthesia induction and maintenance were performed using propofol.

Locations(1)

The Second Affiliated Hospital of Zhejiang University anesthesiology department

Hangzhou, Zhejiang, China

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NCT06952608