Anesthesia, Hemodynamic Instability, Pain
Conditions
Keywords
Anesthesia induction, Ciprofol, propofol, Injection pain
Brief summary
To evaluate the effect of ciprofol anesthesia Induction on hemodynamics in elderly patients undergoing elective noncardiac surgery，a prospective, randomized, controlled trial.
Detailed description
90 elderly patients undergoing noncardiac surgery were randomly divided into propofol group and ciprofol group, who were given propofol 1 \ 2mg/kg or ciprofol 0.2-0.5mg/kg during anesthesia induction respectively. Systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR) and BIS values at various time points during anesthesia induction were collected. At the same time, rates of injection pain, muscle fasciculation, arrhythmia, cough and perioperative hepatic and renal functions were compared between the two groups. The primary outcomes were the fluctuations in hemodynamic parameters during induction. The secondary outcome were adverse reactions, BIS values and changes of hepatic and renal functions during induction.
Interventions
DRUGPropofol
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.
DRUGCiprofol
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.
Sponsors
Xiumei Song
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemodynamic changes：Systolic blood pressure (SBP) | From the beginning of drug administration to 30 minutes after intubation | Systolic blood pressure (SBP) during anesthesia induction |
| Hemodynamic changes: Diastolic blood pressure(DBP) | From the beginning of drug administration to 30 minutes after intubation | Diastolic blood pressure(DBP) during anesthesia induction |
| Hemodynamic changes: Heart rate （HR ） | From the beginning of drug administration to 30 minutes after intubation | Heart rate （HR ）during anesthesia induction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| adverse reactions: injection pain | anesthesia induction | injection pain from propofol or ciprofol intravenous injection |
| adverse reactions: muscle fasciculation | anesthesia induction | muscle fasciculation induced by propofol or ciprofol intravenous induction |
| Monitoring Depth of Anesthesia | anesthesia induction | BIS values |
| perioperative hepatic function: Aspartate Aminotransferase ( AST) | Before surgery , 1day after operation | level of Aspartate Aminotransferase ( AST) |
| perioperative renal function:Blood Urea Nitrogen | Before surgery , 1day after operation | level of Blood Urea Nitrogen（BUN) |
| adverse reactions：arrhythmia | anesthesia induction | arrhythmia induced by propofol or ciprofol intravenous induction |
| perioperative hepatic function: Alanine Aminotransferase ( ALT) | Before surgery , 1day after operation | level of Alanine Aminotransferase ( ALT) |
| perioperative renal function: creatine | Before surgery , 1day after operation | level of creatine |
Contacts
Primary ContactXiumei Song, Doctor
Backup ContactJinwan Guo, Master
Outcome results
None listed