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To evaluate the effect of ciprofol anesthesia Induction on hemodynamics in elderly patients undergoing elective noncardiac surgery,a prospective, randomized, controlled trial.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| propofol group | Active Comparator | According to grouping,patients were premeditated with injection of Propofol 1-2mg / kg IV . If BIS is ≤ 60, Tracheal intubation was facilitated with cisatracurium 0.2mg/kg a IV and sufentanil 0.3 μ g / kg IV. if BIS is >60, propofol 0.5mg/kg was titrated intravenously, with an interval of more than 1min until the BIS is ≤ 60,and intubation was performed after cisatracurium and sufentanil injected .General anesthesia was maintained with Propofol and remifentanil. |
|
| ciprofol group | Experimental | According to grouping,patients were premeditated with injection of ciprofol 0.2-0.5mg/kg IV. If BIS is ≤ 60, Tracheal intubation was facilitated with cisatracurium 0.2mg/kg a IV and sufentanil 0.3 μ g / kg IV. if BIS is >60, ciprofol 0.1mg/kg was titrated intravenously, with an interval of more than 1min until the BIS is ≤ 60,and intubation was performed after cisatracurium and sufentanil injected .General anesthesia was maintained with Propofol and remifentanil in both groups. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propofol | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Hemodynamic changes:Systolic blood pressure (SBP) | Systolic blood pressure (SBP) during anesthesia induction | From the beginning of drug administration to 30 minutes after intubation |
| Hemodynamic changes: Diastolic blood pressure(DBP) | Diastolic blood pressure(DBP) during anesthesia induction | From the beginning of drug administration to 30 minutes after intubation |
| Hemodynamic changes: Heart rate (HR ) | Heart rate (HR )during anesthesia induction | From the beginning of drug administration to 30 minutes after intubation |
| Measure | Description | Time Frame |
|---|---|---|
| adverse reactions: injection pain | injection pain from propofol or ciprofol intravenous injection | anesthesia induction |
| adverse reactions: muscle fasciculation | muscle fasciculation induced by propofol or ciprofol intravenous induction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiumei Song, Doctor | Contact | +8613969050425 | ssm801117@163.com | |
| Jinwan Guo, Master | Contact | _+8617686830961 | guojinwan2010@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiumei Song, Doctor | Qian fo shan hospitial of shan dong province, China | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34116176 | Background | Teng Y, Ou M, Wang X, Zhang W, Liu X, Liang Y, Li K, Wang Y, Ouyang W, Weng H, Li J, Yao S, Meng J, Shangguan W, Zuo Y, Zhu T, Liu B, Liu J. Efficacy and safety of ciprofol for the sedation/anesthesia in patients undergoing colonoscopy: Phase IIa and IIb multi-center clinical trials. Eur J Pharm Sci. 2021 Sep 1;164:105904. doi: 10.1016/j.ejps.2021.105904. Epub 2021 Jun 8. | |
| 35302207 |
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We plan to upload and share data with other researchers. Protecting patient privacy when sharing patient-level data from clinical trial
study protocol and Informed Consent Form will available before 2024/1/1 Statistical Analysis Plan and Clinical Study Report will available before 2024/6/1
All registered researchers
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| C000730795 | (2-(1R)-1-cyclopropyl)ethyl-6-isopropyl-phenol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Ciprofol | Drug | 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. |
|
| anesthesia induction |
| adverse reactions:arrhythmia | arrhythmia induced by propofol or ciprofol intravenous induction | anesthesia induction |
| perioperative hepatic function: Aspartate Aminotransferase ( AST) | level of Aspartate Aminotransferase ( AST) | Before surgery , 1day after operation |
| perioperative hepatic function: Alanine Aminotransferase ( ALT) | level of Alanine Aminotransferase ( ALT) | Before surgery , 1day after operation |
| perioperative renal function: creatine | level of creatine | Before surgery , 1day after operation |
| perioperative renal function:Blood Urea Nitrogen | level of Blood Urea Nitrogen(BUN) | Before surgery , 1day after operation |
| Monitoring Depth of Anesthesia | BIS values | anesthesia induction |
| Background |
| Wang X, Wang X, Liu J, Zuo YX, Zhu QM, Wei XC, Zou XH, Luo AL, Zhang FX, Li YL, Zheng H, Li H, Wang S, Wang DX, Guo QL, Liu CM, Wang YT, Zhu ZQ, Wang GY, Ai YQ, Xu MJ. Effects of ciprofol for the induction of general anesthesia in patients scheduled for elective surgery compared to propofol: a phase 3, multicenter, randomized, double-blind, comparative study. Eur Rev Med Pharmacol Sci. 2022 Mar;26(5):1607-1617. doi: 10.26355/eurrev_202203_28228. |
| 35916802 | Background | Qin K, Qin WY, Ming SP, Ma XF, Du XK. Effect of ciprofol on induction and maintenance of general anesthesia in patients undergoing kidney transplantation. Eur Rev Med Pharmacol Sci. 2022 Jul;26(14):5063-5071. doi: 10.26355/eurrev_202207_29292. |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |