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在接受择期手术的老年患者中进行脑电双频指数监测麻醉诱导:一项前瞻性、单中心、双盲、随机对照研究比较丙泊酚和七氟醚。

Bispectral Index-Monitored Anesthesia Induction in Older Adults Undergoing Elective Surgery: Comparing Ciprofol and Propofol in a Prospective, Single-Center, Double-Blind, Randomized Controlled Study.

机构信息

Department of Anesthesiology, Jiangxi Provincial People's Hospital, The First Affiliated Hospital of Nanchang Medical College, Nanchang, Jiangxi, 330006, People's Republic of China.

The Third Affiliated Hospital, Jiangxi Medical College, Nanchang University, Nanchang, Jiangxi, 330006, People's Republic of China.

出版信息

Drug Des Devel Ther. 2024 Nov 5;18:4993-5003. doi: 10.2147/DDDT.S484532. eCollection 2024.

DOI:10.2147/DDDT.S484532
PMID:39525043
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11549918/
Abstract

PURPOSE

Ciprofol, a new sedative anesthetic developed in China, offers rapid onset and recovery, reduced injection pain, and stable circulation. However, its effect on blood pressure during anesthesia induction in older adults remains unclear. To compare the effects of propofol and ciprofol on hypotension induced by general anesthesia in older adults.

PATIENTS AND METHODS

This prospective, single-center, double-blind, randomized, controlled clinical study enrolled 117 older adults undergoing surgery. Patients in the ciprofol group (group C) received an intravenous injection of ciprofol (0.3 mg/kg, n=57), while the propofol group (group P) received an intravenous injection of propofol (1.5 mg/kg, n=58). The primary outcome was the incidence of hypotension (mean arterial pressure (MAP) decreased by > 30% from baseline or MAP< 65 mmHg). Secondary outcomes included induction success rate (bispectral index (BIS) value ≤60 and Modified Observer's Assessment of Alertness/Sedation Scale (MOAA/S) score ≤1), injection pain, number of drug additions, time to BIS 60, time to eyelash reflex disappearance, blood pressure changes, incidence of hypertension, tachycardia and BIS values before and after administration.

RESULTS

The incidence of induced hypotension was 26.3% (15/57) in group C and 48.3% (28/58) in group P (OR=0.383, 95% CI:175-0.837, P =0.015). Group C had significantly lower injection pain incidence (5.3% vs 20.7%, OR=0.213, 95% CI: 0.057-0.801, p=0.014). Both groups had a 100% induction success rate, with no significant difference in the number of additional doses. Post-intubation hypertension and tachycardia incidence were not significantly different. Group C showed less blood pressure decrease during induction and a deeper anesthesia level.

CONCLUSION

Compared to propofol, ciprofol reduces the incidence of induced hypotension in older adults and maintains more stable blood pressure during induction. Additionally, ciprofol reduces injection pain and provides a good depth of anesthesia, making it a safe and effective option for anesthesia induction in older adults.

TRIAL REGISTRATION CLINICALTRIALSGOV IDENTIFIER

ChiCTR2200066053.

摘要

目的

西普罗夫是中国研发的一种新型镇静麻醉剂,具有起效快、恢复快、注射疼痛减轻、循环稳定等优点。但在老年患者全麻诱导期对血压的影响尚不清楚。比较丙泊酚和西普罗夫对老年患者全麻诱导期低血压的影响。

患者和方法

这是一项前瞻性、单中心、双盲、随机、对照临床试验,纳入 117 例拟行手术的老年患者。西普罗夫组(C 组)患者静脉注射西普罗夫(0.3mg/kg,n=57),丙泊酚组(P 组)患者静脉注射丙泊酚(1.5mg/kg,n=58)。主要结局为低血压发生率(平均动脉压(MAP)较基础值下降≥30%或 MAP<65mmHg)。次要结局包括诱导成功率(脑电双频指数(BIS)值≤60 和改良警觉/镇静评分(MOAA/S)评分≤1)、注射疼痛、追加药物例数、BIS 值达 60 所需时间、睫毛反射消失时间、血压变化、高血压、心动过速发生率及用药前后 BIS 值。

结果

C 组低血压发生率为 26.3%(15/57),P 组为 48.3%(28/58)(OR=0.383,95%CI:175-0.837,P=0.015)。C 组注射疼痛发生率明显较低(5.3%比 20.7%,OR=0.213,95%CI:0.057-0.801,p=0.014)。两组诱导成功率均为 100%,追加药物例数无显著差异。插管后高血压和心动过速发生率无显著差异。C 组诱导时血压下降较少,麻醉深度较深。

结论

与丙泊酚相比,西普罗夫可降低老年患者全麻诱导期低血压的发生率,并在诱导期维持更稳定的血压。此外,西普罗夫还可减轻注射疼痛,提供良好的麻醉深度,是老年患者安全有效的麻醉诱导选择。

临床试验注册

ClinicalTrials.gov 标识符:ChiCTR2200066053。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a86a/11549918/de282c3a5d78/DDDT-18-4993-g0004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a86a/11549918/8c5cad9baeb1/DDDT-18-4993-g0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a86a/11549918/d634d755e207/DDDT-18-4993-g0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a86a/11549918/fbd908728070/DDDT-18-4993-g0003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a86a/11549918/de282c3a5d78/DDDT-18-4993-g0004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a86a/11549918/8c5cad9baeb1/DDDT-18-4993-g0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a86a/11549918/d634d755e207/DDDT-18-4993-g0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a86a/11549918/fbd908728070/DDDT-18-4993-g0003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a86a/11549918/de282c3a5d78/DDDT-18-4993-g0004.jpg

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