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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age65+
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ciprofol group

    Drug

    General anesthesia induction and maintenance were performed using ciprofol.

  • Propofol group

    Drug

    General anesthesia induction and maintenance were performed using propofol.

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: Ciprofol GroupExperimental treatment 1 intervention
Group B: Propofol groupPlacebo comparator 1 intervention

Trial outcomes

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

Time frame
From the beginning to the end of the surgery

Secondary outcomes

1

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.

Time frame
within 15 minutes after induction of anesthesia
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

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

Time frame
From the beginning to the end of the surgery

Other outcomes

1

Quality of Recovery-15 (QoR-15) score

Time frame
3 day after surgery
2

emergency delirium

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

Time frame
Periprocedural

Sponsors and contacts

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