Actively Recruiting
The Effect of Ciprofol on Intraoperative Hypotension in Elderly Patients Receiving Renin-angiotensin System Inhibitors: a Prospective, Randomized Controlled Trial
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-12-30
140
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate whether ciprofol, a new intravenous anesthetic, can improve blood pressure stability during surgery in elderly patients who have been using renin-angiotensin system inhibitors long-term. These patients often face increased risk of low blood pressure during surgery, which can lead to serious complications like heart and kidney injury or higher mortality. Ciprofol has shown promise in previous studies for better maintaining blood pressure compared to propofol, but more evidence is needed. The study randomly assigns patients undergoing elective abdominal surgery lasting over two hours to receive either ciprofol or propofol for anesthesia induction and maintenance. Both drugs are given intravenously during surgery. The trial is designed as a triple-blind, randomized controlled trial to compare how each anesthetic affects perioperative blood pressure and related outcomes. Participants will be monitored from the start to the end of surgery for blood pressure levels, use of blood pressure medications, anesthesia success, and any adverse events. Additional measures include heart and brain oxygen levels and recovery times. Postoperative complications will be tracked for up to three months. This thorough monitoring aims to understand the safety and hemodynamic effects of ciprofol in this vulnerable group.
CONDITIONS
Brief Title
Effect of Ciprofol on Intraoperative Hypotension in Elderly Patients Receiving Renin-angiotensin System Inhibitors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients undergoing elective abdominal surgery under general anesthesia
- Surgery duration longer than 2 hours
- Receiving renin-angiotensin system inhibitor therapy for more than 3 months before surgery
- Age 65 years or older
- ASA classification II-III
- Provided informed consent
You will not qualify if you...
- Allergy to opioids, propofol, or ciprofol components
- Expected difficult airway or difficult mask ventilation
- Body mass index less than 18 or greater than 35 kg/m²
- Severe liver dysfunction (high bilirubin or liver enzymes)
- Severe kidney impairment (low creatinine clearance)
- Certain heart conditions including severe arrhythmias or unstable angina
- Preoperative cognitive or psychiatric disorders
- Abnormal thyroid hormone levels or thyroid therapy history
- Unstable asthma or history of asthma
- Alcohol or drug abuse, chronic opioid use over 3 months
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of surgery (longer than 2 hours)
Participants receive general anesthesia induction and maintenance using either ciprofol or propofol during elective abdominal surgery lasting longer than 2 hours.
1 intraoperative visit
Duration - Up to 3 months
Participants are monitored for postoperative complications and recovery for up to 3 months after surgery.
Approximately 3 follow-up visits
Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital of Zhejiang University anesthesiology department
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
M
Min Yan
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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