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.

IF 4.7 2区医学 Q1 CHEMISTRY, MEDICINAL

Drug Design, Development and Therapy Pub Date : 2024-11-05 eCollection Date: 2024-01-01 DOI:10.2147/DDDT.S484532

Haibin Zou, Fangfang Xi, Yuanyuan Fu, Jinhui Xu, Ping Zhang, Dongge Li, Heguo Luo

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引用次数: 0

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.

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对接受择期手术的老年人进行双谱指数监测麻醉诱导：在一项前瞻性、单中心、双盲、随机对照研究中比较 Ciprofol 和 Propofol。

目的：环丙酚是中国开发的一种新型镇静麻醉剂，具有起效快、恢复快、注射疼痛轻、循环稳定等特点。然而，它对老年人麻醉诱导过程中血压的影响仍不明确。目的：比较丙泊酚和环丙酚对老年人全身麻醉诱导低血压的影响：这项前瞻性、单中心、双盲、随机对照临床研究共招募了 117 名接受手术的老年人。环丙酚组（C 组）患者静脉注射环丙酚（0.3 毫克/千克，57 人），丙泊酚组（P 组）患者静脉注射丙泊酚（1.5 毫克/千克，58 人）。主要结果是低血压的发生率（平均动脉压（MAP）比基线下降 > 30% 或 MAP< 65 mmHg）。次要结果包括诱导成功率（双谱指数（BIS）值≤60 和改良观察者警觉性评估/镇静量表（MOAA/S）评分≤1）、注射疼痛、药物添加次数、BIS 值达到 60 的时间、睫毛反射消失的时间、血压变化、高血压发生率、心动过速和用药前后的 BIS 值：C 组诱发低血压的发生率为 26.3%（15/57），P 组为 48.3%（28/58）（OR=0.383，95% CI：175-0.837，P=0.015）。C 组的注射疼痛发生率明显较低（5.3% 对 20.7%，OR=0.213，95% CI：0.057-0.801，P=0.014）。两组的诱导成功率均为 100%，追加剂量的数量无明显差异。插管后高血压和心动过速的发生率无明显差异。C组在诱导过程中血压下降较少，麻醉程度较深：结论：与异丙酚相比，环丙酚可降低老年人诱导低血压的发生率，并在诱导过程中保持更稳定的血压。此外，环丙酚还能减轻注射疼痛，并提供良好的麻醉深度，是老年人麻醉诱导的安全有效选择：ChiCTR2200066053。

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来源期刊

Drug Design, Development and Therapy CHEMISTRY, MEDICINAL-PHARMACOLOGY & PHARMACY

CiteScore

9.00

自引率

0.00%

发文量

382

审稿时长

>12 weeks

期刊介绍： Drug Design, Development and Therapy is an international, peer-reviewed, open access journal that spans the spectrum of drug design, discovery and development through to clinical applications. The journal is characterized by the rapid reporting of high-quality original research, reviews, expert opinions, commentary and clinical studies in all therapeutic areas. Specific topics covered by the journal include: Drug target identification and validation Phenotypic screening and target deconvolution Biochemical analyses of drug targets and their pathways New methods or relevant applications in molecular/drug design and computer-aided drug discovery* Design, synthesis, and biological evaluation of novel biologically active compounds (including diagnostics or chemical probes) Structural or molecular biological studies elucidating molecular recognition processes Fragment-based drug discovery Pharmaceutical/red biotechnology Isolation, structural characterization, (bio)synthesis, bioengineering and pharmacological evaluation of natural products** Distribution, pharmacokinetics and metabolic transformations of drugs or biologically active compounds in drug development Drug delivery and formulation (design and characterization of dosage forms, release mechanisms and in vivo testing) Preclinical development studies Translational animal models Mechanisms of action and signalling pathways Toxicology Gene therapy, cell therapy and immunotherapy Personalized medicine and pharmacogenomics Clinical drug evaluation Patient safety and sustained use of medicines.