Nepean Hospital, Penrith, New South Wales, Australia.
Am J Crit Care. 2011 Jul;20(4):e90-8. doi: 10.4037/ajcc2011415.
Daily interruption of continuous infusion of sedatives has improved outcomes in patients receiving mechanical ventilation in open-label studies.
To assess the feasibility of a protocol for a double-blind, randomized, controlled trial study on the impact of routine daily interruption of sedation in patients receiving mechanical ventilation.
A total of 50 patients receiving mechanical ventilation were randomized to daily interruption of fentanyl and/or midazolam infusions for up to 6 hours or to usual management of sedation. Blinding was achieved by using replacement infusions (saline or active drug in saline).
The recruitment target of 80 patients was not met in an extended time frame. Propofol was used outside the protocol in 27% of patients in the intervention group and 17% of patients in the control group (P = .10). A total of 15% of the intervention group and 12% of the control group never had replacement infusions started (P = .77), and replacement infusions were started on only approximately one-third of eligible days in patients who received replacement infusions. The mean doses of fentanyl and midazolam were similar. The blinding strategy was safe and effective: no patients had unplanned extubations, and the most frequent reason for ending replacement infusions was completion of the maximum 6-hour period.
The double-blinded design for assessment of sedation interruption in patients receiving mechanical ventilation was safe and effective. Slow recruitment of patients and frequent noncompliance with the protocol suggest that modifications to the protocol are needed.
在开放性研究中，每日中断镇静药物持续输注已改善了接受机械通气患者的结局。
评估一项针对机械通气患者常规每日镇静中断影响的双盲、随机、对照试验方案的可行性。
共纳入 50 例接受机械通气的患者，随机分为每日中断芬太尼和/或咪达唑仑输注持续 6 小时或接受常规镇静管理。通过使用替代输注（生理盐水或生理盐水中的活性药物）实现盲法。
在延长的时间框架内，未能达到 80 例患者的招募目标。在干预组中，27%的患者和对照组中 17%的患者使用了方案外的丙泊酚（P=.10）。干预组中有 15%的患者和对照组中有 12%的患者从未开始使用替代输注（P=.77），而在接受替代输注的患者中，仅有约三分之一的合格日开始了替代输注。芬太尼和咪达唑仑的平均剂量相似。盲法策略是安全有效的：没有患者出现计划外拔管，终止替代输注的最常见原因是完成了最长 6 小时的输注。
用于评估机械通气患者镇静中断的双盲设计是安全有效的。患者招募缓慢且频繁不遵守方案提示需要对方案进行修改。
