PDF(Pubmed)
Abstract：
BACKGROUND: Further clinical validation is required to determine whether transcutaneous electrical acupoint stimulation (TEAS) can replace opioids and be used in combination with remimazolam for sedation during gastrointestinal endoscopy.
METHODS: A total of 108 outpatients who underwent diagnostic gastrointestinal endoscopy were randomly divided into three groups: fentanyl plus remimazolam group (group C), TEAS plus remimazolam group (group E), and placebo-TEAS plus remimazolam group (group P). The assessments of patient satisfaction, physician satisfaction, and pain scale score during the examination constituted the primary endpoints of the study. The secondary endpoints were the time of recovery, recovery of normal behavioral function and discharge, incidence of adverse reactions, and dose of remimazolam.
RESULTS: Compared with group C, group E had a greater median score for patient satisfaction at follow-up and a slightly lower median score for physician satisfaction. The pain score of group E was slightly greater than that of group C, but the difference was not significant. However, in group C, the incidence of hypoxemia, the rate of nausea and the severity of vertigo were greater, and the number of patients discharged and resuming normal behavioral function was greater than those in the other two groups. The dose of remimazolam in group C and group E was less than that in group P.
CONCLUSIONS: TEAS combined with moderate sedation of remimazolam can provide an ideal sedative effect, which preferably suppresses discomfort caused by gastrointestinal endoscopy and has fewer sedation-related complications.
BACKGROUND: ID: NCT05485064; First registration (29/07/2022); Last registration (02/11/2022) (Clinical Trials.gov).
METHODS: A total of 108 outpatients who underwent diagnostic gastrointestinal endoscopy were randomly divided into three groups: fentanyl plus remimazolam group (group C), TEAS plus remimazolam group (group E), and placebo-TEAS plus remimazolam group (group P). The assessments of patient satisfaction, physician satisfaction, and pain scale score during the examination constituted the primary endpoints of the study. The secondary endpoints were the time of recovery, recovery of normal behavioral function and discharge, incidence of adverse reactions, and dose of remimazolam.
RESULTS: Compared with group C, group E had a greater median score for patient satisfaction at follow-up and a slightly lower median score for physician satisfaction. The pain score of group E was slightly greater than that of group C, but the difference was not significant. However, in group C, the incidence of hypoxemia, the rate of nausea and the severity of vertigo were greater, and the number of patients discharged and resuming normal behavioral function was greater than those in the other two groups. The dose of remimazolam in group C and group E was less than that in group P.
CONCLUSIONS: TEAS combined with moderate sedation of remimazolam can provide an ideal sedative effect, which preferably suppresses discomfort caused by gastrointestinal endoscopy and has fewer sedation-related complications.
BACKGROUND: ID: NCT05485064; First registration (29/07/2022); Last registration (02/11/2022) (Clinical Trials.gov).
摘要：
背景：需要进一步的临床验证，以确定经皮穴位电刺激（TEAS）是否可以替代阿片类药物，并与瑞马唑仑联合用于胃肠内窥镜检查期间的镇静作用。
方法：将108例行诊断性胃肠内镜检查的门诊患者随机分为3组：芬太尼加瑞马唑仑组（C组），TEAS加瑞米唑仑组(E组),和安慰剂-TEAS加瑞马唑仑组（P组）。对患者满意度的评估，医生满意度，检查过程中的疼痛评分构成了研究的主要终点。次要终点是恢复时间，恢复正常的行为功能和出院，不良反应发生率，和剂量的雷米唑仑。
结果：与C组相比，E组随访时患者满意度中位数得分较高,而医师满意度中位数得分略低.E组疼痛评分略大于C组,但差异不显著。然而,C组,低氧血症的发生率，恶心的发生率和眩晕的严重程度更大，出院和恢复正常行为功能的人数多于其他两组。C组和E组患者的瑞马唑仑剂量明显少于P组。
结论：TEAS联合适度的瑞马唑仑镇静可提供理想的镇静效果。其优选地抑制由胃肠内窥镜检查引起的不适并且具有较少的镇静相关并发症。
背景：ID：NCT05485064；首次注册（29/07/2022）；最后注册（02/11/2022）（ClinicalTrials.gov）。
方法：将108例行诊断性胃肠内镜检查的门诊患者随机分为3组：芬太尼加瑞马唑仑组（C组），TEAS加瑞米唑仑组(E组),和安慰剂-TEAS加瑞马唑仑组（P组）。对患者满意度的评估，医生满意度，检查过程中的疼痛评分构成了研究的主要终点。次要终点是恢复时间，恢复正常的行为功能和出院，不良反应发生率，和剂量的雷米唑仑。
结果：与C组相比，E组随访时患者满意度中位数得分较高,而医师满意度中位数得分略低.E组疼痛评分略大于C组,但差异不显著。然而,C组,低氧血症的发生率，恶心的发生率和眩晕的严重程度更大，出院和恢复正常行为功能的人数多于其他两组。C组和E组患者的瑞马唑仑剂量明显少于P组。
结论：TEAS联合适度的瑞马唑仑镇静可提供理想的镇静效果。其优选地抑制由胃肠内窥镜检查引起的不适并且具有较少的镇静相关并发症。
背景：ID：NCT05485064；首次注册（29/07/2022）；最后注册（02/11/2022）（ClinicalTrials.gov）。
