The Efficacy and Safety of Diazepam for Intraoperative Blood Pressure Stabilization in Hypertensive Patients Undergoing Vitrectomy Under Nerve Block Anesthesia: A Prospective, Single-Center, Double-Blind, Randomized, Controlled Trial

IF 2.8 3区医学 Q1 Pharmacology, Toxicology and Pharmaceutics

Therapeutics and Clinical Risk Management Pub Date : 2024-01-12 DOI:10.2147/tcrm.s441152

Tianwei Qian, Qiaoyun Gong, Yiyang Shu, Hangqi Shen, Xia Wu, Weijun Wang, Zhihua Zhang, Hui Cao, Xun Xu

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Abstract

Purpose: To evaluate the effectiveness and safety of diazepam in maintaining stable intraoperative blood pressure (BP) in hypertensive patients undergoing vitrectomy under nerve block anesthesia.
Methods: A total of 180 hypertensive patients undergoing vitrectomy with nerve block anesthesia were randomized into two groups. The intervention group was given oral diazepam 60 min before operation, while the control group was given oral placebo 60 min before operation. The primary outcome is the effective rate of intraoperative BP control, defined as systolic blood pressure (SBP) during the operation maintained < 160 mmHg at all timepoints. The logistic regression model will be performed to analyze the compare risk factors for ineffective BP control.
Results: The effective rate of intraoperative SBP control in the diazepam group was significant higher than that in the placebo group from 15 min to 70 min of the surgery (P < 0.05). The proportion of patients with SBP ≥ 180 mmHg at any timepoint from operation to 1 h postoperation was higher in the placebo group (12.22%) than in the diazepam group (2.22%) (P = 0.0096). We observed that the change in SBP from baseline consistently remained higher in the placebo group than in the diazepam group. In the logistic regression analysis, age, years of diagnosed hypertension and SBP 1h before surgery were significant risk factors for ineffective BP control.
Conclusion: This study provides robust evidence supporting the effectiveness of oral diazepam as a pre-surgery intervention in maintaining stable blood pressure during vitrectomy in hypertensive patients.
Trial Registration: Chinese Clinical Trial Registry (ChiCTR), ChiCTR2100041772.

Keywords: nerve block anesthesia, vitrectomy, diazepam, blood pressure stabilization

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在神经阻滞麻醉下进行玻璃体切割术的高血压患者术中使用地西泮稳定血压的有效性和安全性：前瞻性、单中心、双盲、随机对照试验

目的：评估地西泮对在神经阻滞麻醉下接受玻璃体切除术的高血压患者维持术中血压（BP）稳定的有效性和安全性：方法：将接受神经阻滞麻醉玻璃体切除术的 180 名高血压患者随机分为两组。干预组在术前 60 分钟口服地西泮，对照组在术前 60 分钟口服安慰剂。主要结果是术中血压控制的有效率，即术中收缩压（SBP）在所有时间点均保持在 < 160 mmHg。将采用逻辑回归模型分析血压控制无效的风险因素：地西泮组术中 SBP 控制有效率在手术 15 min 至 70 min 显著高于安慰剂组（P <0.05）。从手术到术后 1 h，在任何时间点 SBP≥ 180 mmHg 的患者比例，安慰剂组（12.22%）均高于地西泮组（2.22%）（P = 0.0096）。我们观察到，安慰剂组的 SBP 与基线相比的变化始终高于地西泮组。在逻辑回归分析中，年龄、确诊高血压的年数和术前 1 小时的 SBP 是血压控制无效的重要风险因素：本研究提供了有力的证据支持口服地西泮作为手术前干预对高血压患者在玻璃体切除术中维持血压稳定的有效性：关键词：神经阻滞麻醉，玻璃体切除术，地西泮，血压稳定

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来源期刊

Therapeutics and Clinical Risk Management HEALTH CARE SCIENCES & SERVICES-

CiteScore

5.30

自引率

3.60%

发文量

139

审稿时长

16 weeks

期刊介绍： Therapeutics and Clinical Risk Management is an international, peer-reviewed journal of clinical therapeutics and risk management, focusing on concise rapid reporting of clinical studies in all therapeutic areas, outcomes, safety, and programs for the effective, safe, and sustained use of medicines, therapeutic and surgical interventions in all clinical areas. The journal welcomes submissions covering original research, clinical and epidemiological studies, reviews, guidelines, expert opinion and commentary. The journal will consider case reports but only if they make a valuable and original contribution to the literature. As of 18th March 2019, Therapeutics and Clinical Risk Management will no longer consider meta-analyses for publication. The journal does not accept study protocols, animal-based or cell line-based studies.