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临床试验/IRCT20180929041173N1
IRCT20180929041173N1已完成3 期

Effectiveness of intravenous Dexamethasone on the incidence of nausea and vomiting after deep sedation, in upper GI endoscopy in pediatric patients

Tehran University of Medical Sciences0 个研究点目标入组 98 人开始时间: 待定最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
98

研究概览

简要总结

Objectives: We aimed to evaluate the effect of a single dose of preoperative dexamethasone on postoperative nausea and vomiting (PONV), a frequent complication and a major cause of delayed recovery in pediatric upper gastrointestinal endoscopy (UGIE) under sedation. Methods: In this double-blind randomized controlled study, 98 children aged 2 to 14, with American Society of Anesthesiologists status I to II, and undergoing elective UGIE with deep sedation were included and randomly assigned to 2 groups. Preoperatively, after anesthesia induction with sodium thiopental and maintenance with sevoflurane, patients in the intervention (n = 49) and control (n = 49) groups, respectively received 0.1 mg/kg i.v. dexamethasone and 2 cm3 i.v. 0.9% saline. Postoperatively, PONV incidence was measured as the primary outcome. Results: PONV incidence was significantly less in dexamethasone group (8.2%) compared to the control group (26.5%) (difference = 18.3%, 95% confidence interval: 3.4%-33%, P = 0.016). For secondary outcomes, between-group differences were not statistically significant: incidence of bronchospasm or laryngospasm (both 4.1%, P = 1); emergence delirium assessed with Pediatric Anesthesia Emergence Delirium scale (5.9 ± 3.4 vs 5.7 ± 3.2, P = 0.751); Modified Aldrete score at 0 minutes (9.4 ± 0.8 vs 9.3 ± 0.9, P = 0.909) and at 5 minutes (9.5 ± 0.7 vs 9.4 ± 0.9, P = 0.527); and recovery time (21.1 ± 6.6 vs 23.4 ± 8.6 minutes, P = 0.130). Conclusions: A single preoperative dose of i.v. dexamethasone reduces PONV in children undergoing elective UGIE with deep sedation, but has no significant effect on the patient recovery time or the incidence of postoperative bronchospasm or laryngospasm and emergence delirium.

研究设计

研究类型
Interventional

入排标准

年龄范围
2 years 至 14 years(—)
性别
All

入选标准

  • All 2 to 14 year-old children, candidate for an elective upper GI endoscopy, according to the pediatric gastroenterologist diagnosis

排除标准

  • Patients with a history of hypersensitivity to the drugs studied
  • Patients with a history of metabolic disease or diabetes
  • Patients with anatomical upper airway disorders
  • Patients diagnosed with behavioral disorders or currently taking psychiatric medication
  • Patients with a history of undergoing chemotherapy
  • Patients who have taken a sedative/hypnotic drug prior to endoscopy
  • Patients who are a candidate for an emergency endoscopy
  • Patients whose operation is complicated (e.g. by bleeding) and takes too long to be completed
  • Patients without a parental informed consent

研究者

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