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临床试验/NCT03574246
NCT03574246已完成4 期

The Effect Of Two Packing Types For Throat Pain And Postoperative Nausea And Vomiting During Maxillofacial Surgery

Ankara University1 个研究点 分布在 1 个国家目标入组 111 人开始时间: 2018年1月10日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
111
试验地点
1
主要终点
Postoperative Pain

研究概览

简要总结

Operations of oral maxillofacial surgery cause the blood escape into stomach and trachea. Therefore, throat packing is applied. Endotracheal tube cuff is not protective from aspiration. While packing is preventing blood leakage, it may cause postoperative pain due to the pressure. Packing placed between oropharynx and hypopharynx before surgery to prevent leakage to stomach and trachea. The aim of this study is to compare the efficacy of two packing types in throat pain.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who underwent oral maxillofacial surgery (maxillary and mandibular cysts, orthognathic surgery, palate and alveolar clefts, mandibular and maxillary fractures and reconstruction surgeries) under general anesthesia between the ages of 18-60
  • ASA 1-2 groups of patients
  • Patients who have completed growth and development
  • Patients who are willing to comply with the requirements of the study
  • Patients with complete medical records
  • Operations expected to last at least 2 hours

排除标准

  • Patients with severe systemic disease other than ASA 1-2
  • Difficult entubation story
  • Patients with BMI> 35 kg / m2
  • Contraindications for the use of NSAIDs
  • Patients with diclofenac sodium and metoclopramide allergy
  • Patients whose medical records are inadequate
  • Patients with major tranquilizer or opiate addiction
  • Patients with mental and physical anxiety that would interfere with cooperative operation

研究组 & 干预措施

CHXBNZ

Experimental

Pharyngeal pack moisturized with chlorhexidine gluconate %0,12 benzydamine hydrochloride %0,15 and placed to oropharynx

干预措施: chlorhexidine gluconate %0,12 benzydamine hydrochloride %0,15 (Drug)

SF

Active Comparator

Pharyngeal pack moisturized with %0,9 NaCl and placed to oropharynx

干预措施: %0.9 NaCl Solution (Other)

结局指标

主要结局

Postoperative Pain

时间窗: Postoperatively 24th hour

Measurements with Visual Analog Scale. Minimum value 0, maximum is 10. 0 is no pain and 10 is intolerable pain.

次要结局

  • Nausea and Vomiting(Postoperatively 120th minute)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cagil Vural

Specialist

Ankara University

研究点 (1)

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