Clinical trial
Clinical Observation of Ciprofol for Anesthesia Induction in the Elderly Undergoing Elective Non-cardiac Surgery
Name
YXLL-KY-2022(060)
Description
To evaluate the effect of ciprofol anesthesia Induction on hemodynamics in elderly patients undergoing elective noncardiac surgery，a prospective, randomized, controlled trial.
Trial arms
Trial start
2023-02-01
Estimated PCD
2023-09-30
Trial end
2023-12-31
Status
Not yet recruiting
Phase
Early phase I
Treatment
Propofol
Propofol 1-2mg / kg was for anesthesia induction. Propofol is a hypnotic agent that is used as an induction agent and as a maintenance anaesthetic delivered by continuous i.v. infusion or intermittent i.v. bolus.
Arms:
propofol group
Ciprofol
Ciprofol 0.2～0.5mg/kg was for anesthesia induction. Ciprofol is an intravenous sedative-hypnotic and a short-acting GABAA receptor agonist. It activates GABAergic neurons by enhancing chloride ion influx. It is used for anesthetic induction and maintenance agents include rapid induction of general anesthesia, rapid return of consciousness, minimal residual effects on the central nervous system and less injection pain.
Arms:
ciprofol group
Size
90
Primary endpoint
Hemodynamic changes：Systolic blood pressure (SBP)
From the beginning of drug administration to 30 minutes after intubation
Hemodynamic changes: Diastolic blood pressure(DBP)
From the beginning of drug administration to 30 minutes after intubation
Hemodynamic changes: Heart rate （HR ）
From the beginning of drug administration to 30 minutes after intubation
Eligibility criteria
Inclusion Criteria:
1. ASA physical status Ⅰ-Ⅲ
2. Age over 65 years;
3. Body mass index (BMI) 20 \~ 30 kg/m2 ;
4. Elective noncardiac surgery;
Exclusion Criteria:
1. The patient or his/her family refused to participate in the clinical trial;
2. Severe heart, lung, liver or kidney dysfunction;
3. Expected difficult airway, requiring awake tracheal intubation;
4. Those who are allergic to the drugs used in this study;
5. Unsuccessful tracheal intubation twice;
6. Patients with mental illness or impaired consciousness;
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 90, 'type': 'ESTIMATED'}}
Updated at
2023-01-31
1 organization
2 products
3 indications
Organization
Xiumei SongProduct
PropofolIndication
AnesthesiaIndication
PainIndication
Hemodynamic InstabilityProduct
Ciprofol