成人择期手术患者全麻诱导和维持中应用磷丙泊酚二钠与丙泊酚的疗效和安全性比较

doi:10.13481/j.1671-587X.20250117

摘要/Abstract

摘要：

目的探讨磷丙泊酚二钠（FP）在美国麻醉医师协会（ASA）分级Ⅰ或Ⅱ级的成人择期手术患者全麻诱导和维持阶段的疗效及安全性，为FP在全麻诱导和维持阶段应用提供理论依据。方法选择择期行手术治疗的ASAⅠ或Ⅱ级的成人患者，按就诊时间共有100例患者陆续进入观察，随机分为FP组（50例）和丙泊酚组（50例）。所有患者均完善术前准备，随后缓慢注射咪达唑仑2~3 mg及舒芬太尼0.3 μg·kg^-1，1~2 min后进行麻醉诱导。FP组患者静脉注射FP（10.0~12.5 mg·kg^-1），丙泊酚组患者静脉注射丙泊酚（1.5~2.0 mg·kg^-1），待患者改良警觉/镇静（MOAA/S）评分降至1分后给予肌松药完成诱导。麻醉维持中，FP组患者持续静脉泵注FP，给药速率为12.5~15.0 mg·kg^-1·h^-1；丙泊酚组患者持续泵注丙泊酚，以6 mg·kg^-1·h^-1为起始速率，2组患者均复合瑞芬太尼0.1~0.4 μg·kg^-1·min^-1协同镇痛，根据患者状态适当调整给药速率。记录并比较2组患者诱导前（T₁）、气管插管即刻（T₂）、诱导后5 min（T₃）、诱导后10 min（T₄）、诱导后20 min（T₅）、诱导后30 min（T₆）、诱导后40 min（T₇）和手术结束时（T₈）的收缩压（SBP）、舒张压（DBP）、平均动脉压（MAP）、心率（HR）及脑电双频谱指数（BIS）值；记录2组患者镇静/麻醉起效（MOAA/S评分≤1分）时间及患者睁眼时间和苏醒时间（MOAA/S评分=5分）；观察2组患者术中SBP和BIS值的最低值及所需时间；比较2组患者出现躁动、呛咳、恶心、呕吐、心血管系统或呼吸系统等相关不良反应发生率。结果 2组患者一般资料和手术时长比较差异无统计学意义（P>0.05）；FP组患者诱导时间明显长于丙泊酚组（P<0.05）；在全麻苏醒期，FP组患者睁眼时间和苏醒时间均明显长于丙泊酚组（P<0.05）；在不同时间点，2组患者的MAP比较差异无统计学意义（P>0.05）；FP组患者在T₄、T₅、T₆和T₇时间点的HR均低于丙泊酚组（P<0.05）；FP组患者BIS值的最低值明显小于丙泊酚组，并且FP组患者BIS值降至最低的时间也明显晚于丙泊酚组（P<0.05）；FP组患者的SBP降至最低值的时间晚于丙泊酚组（P<0.05），但2组患者SBP最低值比较差异无统计学意义（P>0.05）；2组患者不良反应发生率比较差异无统计学意义（P>0.05）。结论与丙泊酚比较，注射用FP在ASAⅠ或Ⅱ级的成人择期手术患者的全麻诱导和维持过程中安全有效，不良反应发生率低，是一种新的麻醉选择。

关键词: 磷丙泊酚二钠, 丙泊酚, 镇静, 临床疗效, 全麻

Abstract:

Objective To investigate the efficacy and safety of fospropofol disodium （FP） in the induction and maintenance of general anesthesia in the adult patients graded Ⅰ or Ⅱ by the American Society of Anesthesiologists （ASA） undergoing elective surgery， and to provide the theoretical basis for application of EP in the induction and maintenance of general anesthesia. Methods Adult patients of ASA grade Ⅰ or Ⅱ undergoing elective surgery were selected with a total of 100 patients recruited sequentially according to the time of visit， and they were randomly divided into FP group （50 cases） and propofol group （50 cases）. All patients were prepared preoperatively， and received a slow injection of midazolam （2 to 3 mg） and sufentanil （0.3 μg·kg^-1）， followed by induction of anaesthesia 1 to 2 min later. The patients in FP group were given FP （10.0-12.5 mg·kg^-1） intravenously， and the patients in propofol group were given propofol （1.5-2.0 mg·kg^-1） intravenously. After the Modified Obserational Assessment Alertness/Sedation （MOAA/S） score dropped to 1， muscle relaxant was administrated and the induction was completed. During the maintenance of anaesthesia， the patients in FP group received a continuous intravenous infusion of FP at a rate of 12.5-15.0 mg·kg^-1·h^-1， and the patients in propofol group received a continuous infusion of propofol at a starting rate of 6 mg·kg^-1·h^-1. The patients in two groups additionally received remifentanil （0.1-0.4 μg·kg^-1·min^-1） for co-analgesia， 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 bispectral index （BIS） values of the patients in two groups were recorded at different time points： before induction （T₁）， immediately after tracheal intubation （T₂）， 5 min after induction （T₃）， 10 min after induction （T₄）， 20 min after induction （T₅）， 30 min after induction （T₆）， 40 min after induction （T₇） and at the end of the procedure （T₈）. The time to onset of sedation/anaesthesia （MOAA/S≤1）， the time to eye opening， and the time to awakening （MOAA/S=5） of the patients in two groups were recorded. The lowest intraoperative SBP and BIS values and the time required of the patients in two groups were observed. The incidence of adverse reactions related to agitation， choking， nausea， vomiting and cardiovascular system or respiratory system were compared between two groups. Results There were no statistically differences in the general informations and the duration of surgery of patients between two groups （P>0.05）. The induction time of the patients in FP group （2.39 min） was significantly longer than that in propofol group （0.70 min）（P<0.05）. In the recovery period of general anesthesia， the eye opening time and recovery time of the patients in FP group were significantly longer than those in propofol group （P<0.05）. There were no significant differences in MAP of the patients between two groups at different time points （P>0.05）. The HR at T₄， T₅， T₆， and T₇ time points of the patients in FP group were lower than those in propofol group （P<0.05）. The lowest value of BIS of the patients in FP group was significantly smaller than that in propofol group， and the time taken to reach the lowest value of BIS in FP group was significantly longer than that in propofol group （P<0.05）. The time taken to reach the lowest value of SBP of the patients in FP group was longer than that in propofol group （P<0.05）. However， the lowest value of SBP of the patients and the incidence of adverse reations of the patients in two groups showed no statistical differences （P>0.05）. Conclusion Compared with propofol， FP injection is safe and effective in the induction and maintenance of general anesthesia in adult patients with ASA class Ⅰ or Ⅱ undergoing elective surgery， with a low incidence of adverse reactions， which is a new anesthesia option.

Key words: Fospropofol disodium, Propofol, Sedation, Clinical efficacy, General anesthesia

中图分类号:

R614.3

张东浩,李金辉,班儒孟,闫津硕,刘芮竹,李学锋. 成人择期手术患者全麻诱导和维持中应用磷丙泊酚二钠与丙泊酚的疗效和安全性比较[J]. 吉林大学学报(医学版), 2025, 51(1): 143-149.

Donghao ZHANG,Jinhui LI,Rumeng BAN,Jinshuo YAN,Ruizhu LIU,Xuefeng LI. Comparison of efficacy and safety of fospropofol disodium and propofol applied in induction and maintenance of general anesthesia in adult patients undergoing elective surgery[J]. Journal of Jilin University(Medicine Edition), 2025, 51(1): 143-149.

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Group	Age（year）（x±s）	Gender（Male/Female）	Surgical duration （t/min） [M（P₂₅， P₇₅)]	BMI (kg·m^-2)（x±s）	ASA Ⅰ or Ⅱ
Propofol	37.82±11.76	26/24	77.5（60.0，100.0）	22.80±2.86	11/39
FP	37.40±11.97	27/23	87.5（65.0，112.5）	23.62±2.94	10/40
t/Z/x²	0.177	0.040	0.732	1.412	0.161
P	0.860	0.841	0.464	0.060	0.806

Group	Induction time	Eye-opening time	Recovery time
Propofol	0.70（0.65，0.75）	10.00（8.00，11.00）	12.00（10.75，14.25）
FP	2.39（2.25，2.50）	16.00（14.00，18.25）	20.00（19.00，23.00）
Z	8.627	7.959	8.370
P	<0.001	<0.001	<0.001

Group	T₁	T₂	T₃	T₄	T₅	T₆	T₇	T₈
Propofol	89.84±7.45	78.46±7.04	75.68±6.99	78.10±8.34	79.44±7.73	79.80±6.88	81.48±7.66	88.82±9.04
FP	91.46±7.13	80.16±4.85	77.96±5.79	76.98±5.85	77.12±6.68	78.84±6.94	81.26±7.32	88.14±6.67
t	1.111	1.407	1.777	0.778	1.606	0.695	0.147	0.428
p	0.269	0.163	0.079	0.439	0.112	0.489	0.884	0.670

Group	T₁	T₂	T₃	T₄	T₅	T₆	T₇	T₈
Propofol	85.70±7.32	71.10±6.60	67.52±10.00	66.30±9.90	65.30±7.60	66.70±6.06	61.8±6.40	73.3±7.20
FP	84.30±10.90	70.20±7.70	63.90±9.20	62.30±9.10	60.40±7.00	60.80±6.47	66.9±8.10	72.6±8.30
t	0.420	0.649	1.880	2.237	3.398	4.676	3.510	0.426
P	0.709	0.518	0.063	0.028	<0.001	<0.001	<0.001	0.671

Group	Minimum SBP （x±s， P/mmHg）	Time taken to reach lowest value of SBP [t/min， M(P₂₅，P₇₅)]	Lowest BIS （x±s）	Time taken to reach lowest value of BIS [t/min， M(P₂₅，P₇₅)]
Propofol	96.90±6.99	9.50(7.00,12.00)	36.00±5.57	10.00(6.00,12.25)
FP	97.24±5.35	16.00(12.75,18.35)	28.78±4.93	15.00(12.00,17.25)
t/Z	0.273	5.643	6.867	5.600
P	0.785	<0.001	<0.001	<0.001