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右美托咪定用于日常麻醉实践中的清醒镇痛:一项前瞻性随机对照试验。

Sedoanalgesia with dexmedetomidine in daily anesthesia practices: a prospective randomized controlled trial.

作者信息

Oğuz Ali Kendal, Soyalp Celaleddin, Tunçdemir Yunus Emre, Tekeli Arzu Esen, Yüzkat Nureddin

机构信息

Department of Anesthesiology and Reanimation, Health Science University, Gazi Yaşargil Training and Research Hospital, Diyarbakır, Turkey.

Department of Anesthesiology and Reanimation, Faculty of Medicine, Van Yüzüncü Yıl University, Van, Turkey.

出版信息

BMC Anesthesiol. 2025 Jan 29;25(1):45. doi: 10.1186/s12871-025-02918-1.

DOI:10.1186/s12871-025-02918-1
PMID:39881245
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11776121/
Abstract

BACKGROUND

Patient safety is important in daily anesthesia practices, and providing deep anesthesia is difficult. Current debates on the optimal anesthetic agents highlight the need for safer alternatives. This study was justified by the need for safer and more effective anesthetic protocols for outpatient hysteroscopic procedures, particularly those conducted outside the operating room. Propofol, while widely used, has significant limitations, including respiratory depression, hemodynamic instability, and delayed recovery when higher doses are required for adequate sedation. The addition of opioids to propofol, though beneficial for analgesia, introduces risks such as hypoxemia and hypotension. These challenges necessitate exploring alternative combinations that balance sedation depth with fewer side effects.

OBJECTIVE

To assess the efficacy and safety of deep sedoanalgesia achieved with dexmedetomidine-propofol versus remifentanil-propofol combinations in daily anesthesia practices.

DESIGN

Prospective randomized clinical study.

SETTINGS

This study was carried out at Dursun Odabaş Medical Center.

PATIENTS

Eighty ASA I-II patients, aged 18-65, scheduled for elective hysteroscopic interventions under sedoanalgesia were included in the study.

MAIN OUTCOME MEASURES

The primary aim of our study was to identify an anesthetic agent combination capable of delivering effective and safe deep sedation, with sedation depth assessed via the Ramsey Sedation Score (RSS) and respiratory safety evaluated through desaturation rates. Secondary endpoints included Visual Analogue Scale (VAS) scores, oxygen saturation (SpO2), patient, surgeon, and anesthesiologist satisfaction scores, hemodynamic parameters, the time to achieve an RSS > 4, the time to reach a Modified Aldrete Score (MAS) > 9, and the requirement for mask ventilation and jaw thrust maneuvers.

INTERVENTIONS

Patients were randomized into two groups (n = 40 each): Group DP (Dexmedetomidine-Propofol): A bolus of 1 mg/kg IV propofol and 1 mcg/kg IV dexmedetomidine over 10 min, followed by a continuous infusion of 0.2-1.4 mcg/kg/hour. Group RP (Remifentanil-Propofol): A bolus of 1 mg/kg IV propofol and 0.25 mcg/kg IV remifentanil, followed by a continuous infusion of 0.025-0.1 mcg/kg/minute.

RESULTS

Patients in the DP group exhibited significantly lower VAS scores and desaturation rates (p = 0.003) compared to the RP group. Satisfaction scores (patient, surgeon, anesthesiologist) and integrated pulmonary index (IPI) values were significantly higher in the DP group (p < 0.05).

CONCLUSION

The dexmedetomidine-propofol combination is an effective and safe anesthetic regimen for deep sedation in outpatient hysteroscopic procedures, offering adequate sedation and superior preservation of respiratory function. Additionally, the dexmedetomidine-propofol combination ensures more stable hemodynamics, with a lower incidence of hypoxia, and results in higher satisfaction rates among patients, surgeons, and anesthesiologists.

TRIAL REGISTRATION

Clinical Trials ID is NCT05674201 Date 2022.12.07.

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d4de/11776121/ef709b8324b3/12871_2025_2918_Fig6_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d4de/11776121/f717a47320bc/12871_2025_2918_Fig1_HTML.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d4de/11776121/15d094f44063/12871_2025_2918_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d4de/11776121/93f3110f2d48/12871_2025_2918_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d4de/11776121/ef709b8324b3/12871_2025_2918_Fig6_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d4de/11776121/f717a47320bc/12871_2025_2918_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d4de/11776121/0af6f069872a/12871_2025_2918_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d4de/11776121/6f8ea68f2912/12871_2025_2918_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d4de/11776121/15d094f44063/12871_2025_2918_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d4de/11776121/93f3110f2d48/12871_2025_2918_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d4de/11776121/ef709b8324b3/12871_2025_2918_Fig6_HTML.jpg
摘要

背景

患者安全在日常麻醉实践中至关重要,而提供深度麻醉具有挑战性。当前关于最佳麻醉药物的争论凸显了对更安全替代方案的需求。本研究的开展是因为需要为门诊宫腔镜手术制定更安全、更有效的麻醉方案,尤其是在手术室以外进行的手术。丙泊酚虽被广泛使用,但存在显著局限性,包括呼吸抑制、血流动力学不稳定,以及在需要更高剂量以达到充分镇静时恢复延迟。在丙泊酚中添加阿片类药物虽有利于镇痛,但会带来低氧血症和低血压等风险。这些挑战使得有必要探索能在较少副作用的情况下平衡镇静深度的替代组合。

目的

评估在日常麻醉实践中,右美托咪定 - 丙泊酚与瑞芬太尼 - 丙泊酚组合用于深度镇静镇痛的有效性和安全性。

设计

前瞻性随机临床研究。

地点

本研究在杜尔孙·奥达巴斯医学中心进行。

患者

纳入80例年龄在18 - 65岁、ASA I - II级、计划在镇静镇痛下进行择期宫腔镜干预的患者。

主要观察指标

本研究的主要目的是确定一种能够提供有效且安全的深度镇静的麻醉药物组合,通过拉姆齐镇静评分(RSS)评估镇静深度,通过去饱和率评估呼吸安全性。次要终点包括视觉模拟评分(VAS)、血氧饱和度(SpO₂)、患者、外科医生和麻醉医生的满意度评分、血流动力学参数、达到RSS > 4的时间、达到改良Aldrete评分(MAS)> 9的时间,以及面罩通气和下颌前推操作的需求。

干预措施

患者被随机分为两组(每组n = 40):DP组(右美托咪定 - 丙泊酚):静脉注射1 mg/kg丙泊酚和1 mcg/kg右美托咪定,持续10分钟,随后以0.2 - 1.4 mcg/kg/小时持续输注。RP组(瑞芬太尼 - 丙泊酚):静脉注射1 mg/kg丙泊酚和0.25 mcg/kg瑞芬太尼,随后以0.025 - 0.1 mcg/kg/分钟持续输注。

结果

与RP组相比,DP组患者的VAS评分和去饱和率显著更低(p = 0.003)。DP组的满意度评分(患者、外科医生、麻醉医生)和综合肺指数(IPI)值显著更高(p < 0.05)。

结论

右美托咪定 - 丙泊酚组合是门诊宫腔镜手术深度镇静的一种有效且安全的麻醉方案,能提供充分的镇静并更好地维持呼吸功能。此外,右美托咪定 - 丙泊酚组合可确保血流动力学更稳定,低氧血症发生率更低,患者、外科医生和麻醉医生的满意度更高。

试验注册

临床试验标识号为NCT05674201,日期为2022年12月7日。

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