| Aim:To investigate the efficacy and safety of Fospropofol Disodium(FD)in the induction and maintenance phases of general anesthesia for elective surgery in adults.Methods:In this randomized,single-blind,controlled study,100 patients were randomly divided into a fospropofol disodium group(Group A)and a propofol group(Group B).All patients were prepared preoperatively.To prevent hypotension,200 to 300 ml of fluid was rehydrated before surgery,followed by a slow injection of midazolam 2 to 3 mg and sufentanil 0.3 μg/kg,followed by induction of anaesthesia 1 to 2 minutes later: FP(10-12.5 mg/kg)intravenously in group A and propofol(1.5-2mg/kg)intravenously in group B.The patients waited for their modified alertness/sedation(MOAA/S)score to drop.The induction was completed with inotropic drugs after the MOAA/S score dropped to 1.During maintenance of anaesthesia,FP was continuously injected intravenously at a rate of 12.5-15 mg/kg/h in group A.In group B,propofol was continuously injected at a starting rate of 6 mg/kg/h.Both groups were combined with remifentanil 0.1-0.4 μg/kg/min for coanalgesia,and the rate of administration was adjusted according to the patient’s status.Systolic blood pressure(SBP),diastolic blood pressure(DBP),mean arterial pressure(MAP),heart rate(HR)and BIS values were recorded before induction(T1),immediately after tracheal intubation(T2),5 minutes after induction(T3),10 minutes after induction(T4),20 minutes after induction(T5),30 minutes after induction(T6),40 minutes after induction(T7)and at the end of the procedure(T8)in both groups.The time to onset of sedation/anaesthesia(MOAA/S≤1)and the success rate of sedation/anaesthesia(MOAA/S≤1)were recorded in both groups;the time to eye opening,time to awakening(MOAA/S score=5),duration of surgery and the unit time dose of fospropofol disodium,propofol and remifentanil during maintenance of anaesthesia were recorded in both groups;the lowest intraoperative systolic blood pressure and BIS values and the time required were observed in both groups.The lowest intraoperative systolic and BIS values and the time required were observed in both groups;the incidence of adverse events related to agitation,choking,nausea,vomiting,cardiovascular or respiratory was compared between the two groups.Results:There was no significant difference between the two groups of subjects in terms of general information and duration of surgery.The induction time in the experimental group was significantly longer than that in the control group,which was statistically significant(P < 0.05).There was no significant difference between the two groups in terms of MAP at different time points,with an overall trend of increase followed by decrease,P > 0.05.The HR levels at time points T4,T5,T6 and T7 in the experimental group were lower than those in the control group,which was statistically significant,P < 0.05.The BIS levels at time points T4 and T5 in the experimental group were lower than those in the control group,P < 0.05.The time to the lowest value of SBP in the experimental group was later than that in the control group,which was statistically significant,P < 0.05.However,the lowest value of SBP in the two groups was similar,which was not statistically significant,P >0.05.The lowest value of BIS in the experimental group was significantly smaller than that in the control group,and the time to the lowest value of BIS in the experimental group was also significantly smaller than that in the control group,which was statistically significant,P < 0.05.There was no significant difference in the unit time dose of remifentanil between the two groups,P > 0.05.The incidence of adverse reactions in the two groups was not statistically significant,P > 0.05.Conclusion:Injectable fospropofol disodium is safe and effective in the induction and maintenance of general anesthesia in adult elective surgery patients with ASA class I or II,and the incidence of adverse reactions is low,which is a new anesthesia option. |
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