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临床试验/NCT04819659
NCT04819659已完成不适用

Investigation of the Effect of Pharyngeal Packing on Postoperative Gastric Volume in Patients Undergoing Nasal Surgery

Istanbul University2 个研究点 分布在 2 个国家目标入组 180 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
180
试验地点
2
主要终点
The crosssectional area (ACSA) (Postoperative) (mm2) (Postoperative)

研究概览

简要总结

Pharyngeal packing is a frequently used application to reduce the incidence and severity of postoperative nausea and vomiting (PONV) in patients who undergo nasal surgery. This study aims to research the effects of PP on gastric antral cross-sectional area (ACSA) and hence gastric volume as assessed by ultrasound, therewithal PONV and sore throat were evaluated as secondary outcomes in rhino logic surgeries (Septorhinoplasty, Septoplasty, Functional endoscopic sinus surgery).

详细描述

Postoperative nausea and vomiting (PONV) after nasal surgery (Septorhinoplasty, Septoplasty, Functional endoscopic sinus surgery) is a very common complication (34-60%). Therefore, pharangeal packing was performed to prevent blood ingestion so as to decrease the incidence of PONV and the risk of aspiration. Also, gastric blood is known to be a powerful emetic. Actually, there is not any evidence in the literature reporting the quantitative values of gastric volumes due to blood ingestion. The aim of this study is to research the effect of pharyngeal packing on the perioperative gastric antral cross-sectional area (ACSA) so the gastric volumes.

Measurements were performed by ultrasound with convex probe in right lateral decubitus position, in order to evaluate the effectiveness of pharyngeal packing in patients undergoing nasal surgery, and to show its effects on PONV and sore throat.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • undergoing elective nasal or paranasal sinus surgery following overnight fasting
  • 18-70 years of age
  • accepting to join the study
  • American Society of Anesthesiologist (ASA) classification system I-III
  • Body mass Index (BMI) < 30 kg/m2

排除标准

  • ASA classification higher than III
  • Age younger than 18 years
  • BMI>30 kg/m2
  • Preoperative vomiting or antiemetic medication therapy
  • Intubation needing more than two laryngoscopy attempts
  • Not agreeing to participate in the study
  • Coagulation disorders
  • Diseases or conditions affecting gastric volume or motility

结局指标

主要结局

The crosssectional area (ACSA) (Postoperative) (mm2) (Postoperative)

时间窗: 10 minutes before extubation

measurements are done with USG and calculated with this formula CSA = (AP (anterior-posterior) diameter × CC (cranio-caudal) diameter× 3.14) / 4.

次要结局

  • Blood volume in the suction system(in the perioperative period)
  • The severity of sore throat(at the first, second and 24th hours in PACU and at the ward)
  • Postoperative presence and severity of PONV(at the first, second and 24th hours in PACU and at the ward)

研究者

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

Demet Altun

Assoc. Prof. Dr.

Istanbul University

研究点 (2)

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