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

NCT06952608 | Recruiting Phase 4 DMC

• 1 other identifier: 2025-0279
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ciprofol; Renin-angiotensin System Inhibitors; Intraoperative Hypotension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• Time-weighted average of hypotension

  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

  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

Other Outcomes (2)

• Quality of Recovery-15 (QoR-15) score

  3 day after surgery

• emergency delirium

  Periprocedural

Study Arms (2)

Ciprofol Group

EXPERIMENTAL

General anesthesia induction and maintenance were performed using ciprofol.

Drug: Ciprofol group

Propofol group

PLACEBO COMPARATOR

General anesthesia induction and maintenance were performed using propofol.

Drug: Propofol group

Interventions

Ciprofol group DRUG

General anesthesia induction and maintenance were performed using ciprofol.

Ciprofol Group

Propofol group DRUG

General anesthesia induction and maintenance were performed using propofol.

Propofol group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The Second Affiliated Hospital of Zhejiang University anesthesiology department

Hangzhou, Zhejiang, 310000, China

RECRUITING

Study Officials

• Min Yan

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  STUDY DIRECTOR

Central Study Contacts

Min Yan

CONTACT

0571-87783759; zryanmin@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2025
• First Posted: May 1, 2025
• Study Start: April 10, 2025
• Primary Completion: February 10, 2026
• Study Completion: April 10, 2026
• Last Updated: December 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)