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The effect of general anesthesia induction with ciprofol in hip fracture surgery of elderly patients: a prospective randomized controlled trial

The effect of general anesthesia induction with ciprofol in hip fracture surgery of elderly patients

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400080294
Enrollment
Unknown
Registered
2024-01-25
Start date
2024-02-01
Completion date
Unknown
Last updated
2024-01-28

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

Conditions

hip fracture

Interventions

Group C:Induction of general anesthesia using ciprofol
Group P:Induction of general anesthesia using propofol

Sponsors

Lishui People’s Hospital, The Sixth Affiliated Hospital of Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
75 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 75 years < age = 90 years (male and female not limited); 2. ASA was classified as grade ? - ?; 3. 18 kg/m2 = BMI = 30kg/m2; 4. Respiratory rate in screening period and baseline period should be = 10 and = 24 times / min; SpO2 should be = 95% when absorbing air; SBP = 90 mmHg; DBP = 60 mmHg; Heart rate should be = 60 and = 100 beats / min; 5. Be able to understand the procedures and methods of this study, be willing to sign the informed consent and strictly follow the clinical research protocol to complete this study.

Exclusion criteria

Exclusion criteria: 1. Those with contraindications to general anesthesia; 2. Those who need to combine other anesthesia methods besides general intravenous anesthesia, such as inhalation anesthesia, intraspinal anesthesia, nerve block, etc; 3. With infectious heart disease such as myocarditis or endocarditis, sepsis; 4. Brain injury, possible intracranial hypertension, cerebral aneurysm, and cerebrovascular accident; 5. Acute heart failure, unstable angina, myocardial infarction within 6 months before screening, resting ECG heart rate = 50 beats / min, third degree atrioventricular block and other serious arrhythmias, serious heart valve disease; 6. Abnormal liver and kidney function (ALT or AST = 2.5 times the upper limit of normal value, TBIL = 1.5 times the upper limit of normal value), abnormal renal function (bun or urea = 1.5 times the upper limit of normal value, cr> the upper limit of normal value, or dialysis treatment within 28 days before surgery), or obvious abnormal coagulation function (pt/ aptt/tt higher than the upper limit of normal value), anemia or thrombocytopenia (HB = 90g/l, PLT = 80 × 109/l); 7. Those whose blood pressure was not satisfactorily controlled (SBP = 160mmhg and / or DBP = 100 mmHg in sitting position during screening); 8. SBP = 90mmHg in sitting position during screening; 9. Diabetic subjects whose blood glucose was not satisfactorily controlled (fasting blood glucose = 11.1mmol/l and / or random blood glucose = 13.6 mmol/l in the screening period); 10. There was a history of drug abuse and alcohol abuse within 2 years before the screening period, and alcohol abuse was defined as regular drinking of more than 14 times / week (1 time =150 ml wine or 360 ml beer or 45 ml spirits); 11. The subjects who were judged to have difficulties in respiratory tract management were graded as IV by the modified Mahalanobis score; 12. Known or suspected allergy or contraindication to various components of the study drug or other benzodiazepines, opioids, propofol, muscle relaxants, etc; 13. Those who participated in any clinical trial as subjects within 3 months before enrollment; 14. Other circumstances determined by the investigator as unsuitable for enrollment.

Design outcomes

Primary

MeasureTime frame
Incidence of hypotension;Incidence of severe hypotension;

Secondary

MeasureTime frame
Success rate of general anesthesia induction;Time of consciousness disappearance;Incidence of adverse reactions;Frequency of vasoactive drugs;intraoperative awareness;Maximum difference of mean arterial pressure;Maximum heart rate difference;

Countries

China

Contacts

Public ContactDuan gongchen

Lishui People’s Hospital, The Sixth Affiliated Hospital of Wenzhou Medical University

981225178@qq.com+86 189 5709 3030

Outcome results

None listed

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