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NCT Number: NCT06952608

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

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Second Affiliated Hospital of Zhejiang University anesthesiology department

Hangzhou, Zhejiang, 310000, China

Location status: Recruiting

Location contact

Min Yan

CONTACT

[email protected]

15888210247

Min Yan, Doctor

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Ciprofol group

Drug

General anesthesia induction and maintenance were performed using ciprofol.

Propofol group

Drug

General anesthesia induction and maintenance were performed using propofol.

Primary outcomes

  1. The time-weighted average of hypotension

    Time frame: From the beginning to the end of the surgery

    The time-weighted average is measured by calculating the area under the threshold (AUT) divided by the total duration of surgery

Secondary outcomes

  1. Time-weighted average of hypotension

    Time frame: within 15 minutes after induction of anesthesia

    The time-weighted average is measured by calculating the area under the threshold (AUT) divided by the total duration of induction.

  2. Incidence of intraoperative hypotension

    Time frame: From the beginning to the end of the surgery

  3. Dosage of vasoactive drugs

    Time frame: From the beginning to the end of the surgery

  4. Success rate of general anesthesia induction

    Time frame: From the beginning to the end of the surgery

    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

  5. Proportion of intraoperative time with BIS ≤ 60

    Time frame: From the beginning to the end of the surgery

  6. Total dosage of ciprofol and propofol

    Time frame: From the beginning to the end of the surgery

  7. Total dosage of rescue drugs

    Time frame: From start of drug administration to MOAA/S ≤1 (up to 5 minutes)

  8. Time to extubation

    Time frame: Perioperative

  9. Incidence of intraoperative adverse events

    Time frame: From the beginning to the end of the surgery

  10. Incidence of adverse events in the PACU

    Time frame: during the PACU stay

  11. Incidence of perioperative major adverse cardiovascular and cerebrovascular events

    Time frame: Periprocedural

  12. Changes in Stroke Volume Variation (SVV)

    Time frame: Intraoperative

    Nomal value:≤10%,and higher scores mean a worse outcome.

  13. Changes in Cardiac Index (CI)

    Time frame: Intraoperative

    Nomal value:2.5-4.0 L/min/m²,and values outside the normal range suggest worse clinical outcomes

  14. Changes in Systemic Vascular Resistance Index (SVRI)

    Time frame: Intraoperative

    Nomal value :1970-2390 dyn·s·cm-⁵·m²,and values outside the normal range suggest worse clinical outcomes

  15. Changes in Cerebral Oxygen Saturation (rSO₂)

    Time frame: Intraoperative

  16. Postoperative complications

    Time frame: From enrollment to the end of treatment at 3 months

    delirium, myocardial injury, stroke, acute kidney injury, infection, sepsis, etc.

Other outcomes

  1. Quality of Recovery-15 (QoR-15) score

    Time frame: 3 day after surgery

  2. emergency delirium

    Time frame: Periprocedural

    RASS&CAM-ICU, delirium was judged according to whether there were positive features in the questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 1, 2025
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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