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Evaluation of the efficacy and safety of ciprofol in the induction and maintenance period of anesthesia in elderly vulnerable patients: a randomized, controlled clinical trial

Evaluation of the efficacy and safety of ciprofol in the induction and maintenance period of anesthesia in elderly vulnerable patients: a randomized, controlled clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400088936
Enrollment
Unknown
Registered
2024-08-29
Start date
2024-09-10
Completion date
Unknown
Last updated
2024-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-induction hypotension

Interventions

1:Induction dose: Propofol 0.3mg/kg
Maintenance dose: Propofol 0.8mg/kg ·
2:Induction dose: Ciprofol 0.3mg/kg
Maintenance dose: Ciprofol 0.8mg/kg ·

Sponsors

The Traditional Chinese Medicine Hospital of Kunshan
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Age= 60 years old (2) Use a non-invasive continuous arterial blood pressure monitoring system and (3) elective non-cardiac surgery planned under general anesthesia (4) ASA Grading I.~IV. (4) Modified vulnerability index MFI=3 (5) Postoperative planned extubation (6) Informed consent, voluntarily participate in the trial, and sign the informed consent form

Exclusion criteria

Exclusion criteria: (1) Use regional anesthesia (2) Severe liver disease (3) Chronic kidney disease requiring dialysis (4) Gastroesophageal reflux disease (5) Obstructive sleep apnea (6) History of drug dependence (7) Neurological diseases (8) Systolic blood pressure = 180mmHg and/or diastolic blood pressure = 100mmHg at screening (9) Systolic blood pressure < 90mmHg at screening (10) Subjects who are considered inappropriate by the investigator to participate in this study.

Design outcomes

Primary

MeasureTime frame
Bispectral Idex during the period from skin incision to the last skin suture;

Secondary

MeasureTime frame
rate of hypotension after induction;Delirium Screening Scale;Time to loss of eyelid reflex;Time to loss of consciousness after anesthesia induction;Time to tracheal extubation;Time to recovery of consciousness from tracheal extubation;Cardiac output;Stroke variability;Peripheral vascular resistance;Oxygen supply index;Oxygen consumption index;Postoperative delirium-associated serum biomarkers;Modified Aldrete score;Brice questionnaire;rate of adverse events;

Countries

China

Contacts

Public ContactQiao Shigang

Department of Anesthesiology, The Traditional Chinese Medicine Hospital of Kunshan

jsdxyxzz@163.com+86 177 1518 7396

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026