局部麻醉与局部麻醉联合清醒镇静用于腹股沟疝修补术：一项随机对照试验方案
Local Anesthesia Versus Local Anesthesia and Conscious Sedation for Inguinal Hernioplasty: Protocol of a Randomized Controlled Trial.
作者信息
Leake Pierre-Anthony, Toppin Patrick J, Reid Marvin, Plummer Joseph M, Roberts Patrick O, Harding-Goldson Hyacinth, McFarlane Michael E
机构信息
Department of Surgery, Radiology, Anaesthesia and Intensive Care, Faculty of Medical Sciences, University of the West Indies, Kingston, Jamaica.
Tropical Medical Research Institute, University of the West Indies, Kingston, Jamaica.
出版信息
JMIR Res Protoc. 2017 Feb 7;6(2):e20. doi: 10.2196/resprot.6754.
BACKGROUND
Conscious sedation is regularly used in ambulatory surgery to improve patient outcomes, in particular patient satisfaction. Reports suggest that the addition of conscious sedation to local anesthesia for inguinal hernioplasty is safe and effective in improving patient satisfaction. No previous randomized controlled trial has assessed the benefit of conscious sedation in this regard.
OBJECTIVE
To determine whether the addition of conscious sedation to local anesthesia improves patient satisfaction with inguinal hernioplasty.
METHODS
This trial is designed as a single-center, randomized, placebo-controlled, blinded trial of 148 patients. Adult patients diagnosed with a reducible, unilateral inguinal hernia eligible for hernioplasty using local anesthesia will be recruited. The intervention will be the use of intravenous midazolam for conscious sedation. Normal saline will be used as placebo in the control group. The primary outcome will be patient satisfaction, measured using the validated Iowa Satisfaction with Anesthesia Scale. Secondary outcomes will include intra- and postoperative pain, operative time, volumes of sedative agent and local anesthetic used, time to discharge, early and late complications, and postoperative functional status.
RESULTS
To date, 171 patients have been recruited. Surgery has been performed on 149 patients, meeting the sample size requirements. Follow-up assessments are still ongoing. Trial completion is expected in August 2017.
CONCLUSIONS
This randomized controlled trial is the first to assess the effectiveness of conscious sedation in improving patient satisfaction with inguinal hernioplasty using local anesthesia. If the results demonstrate improved patient satisfaction with conscious sedation, this would support routine incorporation of conscious sedation in local inguinal hernioplasty and potentially influence national and international hernia surgery guidelines.
TRIAL REGISTRATION
Clinicaltrials.gov NCT02444260; https://clinicaltrials.gov/ct2/show/NCT02444260 (Archived by WebCite at http://www.webcitation.org/6no8Dprp4).
背景
清醒镇静常用于门诊手术以改善患者预后，尤其是提高患者满意度。报告显示，在腹股沟疝修补术中，在局部麻醉基础上加用清醒镇静对提高患者满意度是安全有效的。此前尚无随机对照试验评估清醒镇静在这方面的益处。
目的
确定在局部麻醉基础上加用清醒镇静是否能提高患者对腹股沟疝修补术的满意度。
方法
本试验设计为一项单中心、随机、安慰剂对照、双盲试验，纳入148例患者。将招募诊断为可复性单侧腹股沟疝且适合采用局部麻醉进行疝修补术的成年患者。干预措施为使用静脉注射咪达唑仑进行清醒镇静。对照组使用生理盐水作为安慰剂。主要结局指标为患者满意度，采用经过验证的爱荷华麻醉满意度量表进行测量。次要结局指标将包括术中和术后疼痛、手术时间、镇静剂和局部麻醉剂使用量、出院时间、早期和晚期并发症以及术后功能状态。
结果
截至目前，已招募171例患者。149例患者已接受手术，达到样本量要求。随访评估仍在进行中。预计试验于2017年8月完成。
结论
这项随机对照试验是首个评估清醒镇静对提高患者对局部麻醉下腹股沟疝修补术满意度有效性的试验。如果结果表明清醒镇静能提高患者满意度，这将支持在局部腹股沟疝修补术中常规采用清醒镇静，并可能影响国家和国际疝手术指南。
试验注册
Clinicaltrials.gov NCT02444260；https://clinicaltrials.gov/ct2/show/NCT02444260（由WebCite存档于http://www.webcitation.org/6no8Dprp4）
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