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

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.

Study Overview

• Status: Recruiting
• Conditions: Intraoperative Hypotension; Ciprofol; Renin-angiotensin System Inhibitors
• Intervention / Treatment: Drug: Ciprofol group; Drug: Propofol group

Detailed Description

Elderly patients receiving long-term renin-angiotensin system inhibitors commonly exhibit reduced vascular elasticity, impaired cardiovascular reserve, and diminished compensatory mechanisms. Regular use of renin-angiotensin system inhibitors has thus emerged as a significant risk factor for intraoperative hypotension, increasing the potential for end-organ injury and closely correlating with postoperative complications such as myocardial injury, acute kidney injury, and increased mortality.

Ciprofol (HSK3486) is a novel intravenous anesthetic agent that has demonstrated efficacy non-inferior to propofol for induction and maintenance of general anesthesia, with an improved safety profile and fewer adverse effects. Recent meta-analyses indicate that ciprofol administration is associated with a significantly reduced incidence of intraoperative hypotension compared with propofol; however, robust evidence from randomized controlled trials (RCTs) remains limited. The present study aims to evaluate the impact of ciprofol on perioperative hemodynamics in elderly patients receiving renin-angiotensin system inhibitors. Given the increased risk of intraoperative hypotension in this patient cohort, the investigation of hemodynamic stability with ciprofol holds substantial clinical significance and may inform anesthetic management strategies for this vulnerable population.

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Min Yan; Phone Number: 0571-87783759; Email: zryanmin@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • The Second Affiliated Hospital of Zhejiang University anesthesiology department
      • Principal Investigator: Min Yan, Doctor
      • Contact: Min Yan; Phone Number: 15888210247; Email: zryanmin@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. History of allergy to opioids, propofol, or ciprofol components.

2. 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.

3. Severe hepatic dysfunction (total bilirubin ≥3.0 mg/dL or AST/ALT ≥2 times the upper limit of normal).
4. Severe renal impairment (creatinine clearance ≤30 mL/min).
5. 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).
6. Preoperative cognitive impairment, cerebrovascular disease, or history of psychiatric illness.
7. Abnormal thyroid-stimulating hormone levels or history of thyroid replacement therapy.
8. Unstable asthma or history of asthma.
9. Alcohol abuse, drug abuse, chronic opioid dependence, or analgesic use exceeding 3 months.
10. Lactating or pregnant women.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ciprofol Group; General anesthesia induction and maintenance were performed using ciprofol.	Drug: Ciprofol group; General anesthesia induction and maintenance were performed using ciprofol.
Placebo Comparator: Propofol group; General anesthesia induction and maintenance were performed using propofol.	Drug: Propofol group; General anesthesia induction and maintenance were performed using propofol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The time-weighted average of hypotension	The time-weighted average is measured by calculating the area under the threshold (AUT) divided by the total duration of surgery	From the beginning to the end of the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time-weighted average of hypotension	The time-weighted average is measured by calculating the area under the threshold (AUT) divided by the total duration of induction.	within 15 minutes after induction of anesthesia
Incidence of intraoperative hypotension		From the beginning to the end of the surgery
Dosage of vasoactive drugs		From the beginning to the end of the surgery
Success rate of general anesthesia induction	MOAA/S score of 1 or less after administration of ciprofol or propofol, 1 or fewer top-up doses, and no use of rescue drug	From the beginning to the end of the surgery
Proportion of intraoperative time with BIS ≤ 60		From the beginning to the end of the surgery
Total dosage of ciprofol and propofol		From the beginning to the end of the surgery
Total dosage of rescue drugs		From start of drug administration to MOAA/S ≤1 (up to 5 minutes)
Time to extubation		Perioperative
Incidence of intraoperative adverse events		From the beginning to the end of the surgery
Incidence of adverse events in the PACU		during the PACU stay
Incidence of perioperative major adverse cardiovascular and cerebrovascular events		Periprocedural
Changes in Stroke Volume Variation (SVV)	Nomal value:≤10%,and higher scores mean a worse outcome.	Intraoperative
Changes in Cardiac Index (CI)	Nomal value:2.5-4.0 L/min/m²,and values outside the normal range suggest worse clinical outcomes	Intraoperative
Changes in Systemic Vascular Resistance Index (SVRI)	Nomal value :1970-2390 dyn·s·cm-⁵·m²,and values outside the normal range suggest worse clinical outcomes	Intraoperative
Changes in Cerebral Oxygen Saturation (rSO₂)		Intraoperative
Postoperative complications	delirium, myocardial injury, stroke, acute kidney injury, infection, sepsis, etc.	From enrollment to the end of treatment at 3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Recovery-15 (QoR-15) score		3 day after surgery
emergency delirium	RASS&CAM-ICU, delirium was judged according to whether there were positive features in the questionnaire	Periprocedural

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Study Director: Min Yan, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2025
• Primary Completion (Estimated): February 10, 2026
• Study Completion (Estimated): April 10, 2026

Study Registration Dates

• First Submitted: April 13, 2025
• First Submitted That Met QC Criteria: April 28, 2025
• First Posted (Actual): May 1, 2025

Study Record Updates

• Last Update Posted (Actual): December 30, 2025
• Last Update Submitted That Met QC Criteria: December 22, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypotension; Physiological Effects of Drugs; Anesthetics; Central Nervous System Depressants; Hypnotics and Sedatives; Anesthetics, Intravenous; Anesthetics, General; Propofol
• Other Study ID Numbers: 2025-0279

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No