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临床试验/NCT04596774
NCT04596774已完成不适用

The Impact of Using Enhanced Recovery After Surgery Approach on Orthognathic Surgery Outcome: A Historical Cohort Study

Istanbul University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2018年8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
90
试验地点
1
主要终点
Length of hospital stay

研究概览

简要总结

Aim: Orthognathic surgeries are generally associated with blood loss, swelling, postoperative nausea vomiting (PONV), and pain. The aim of this study is to improve postoperative outcome in patients undergoing orthognatic surgeries by the use of Enhanced Recovery After Surgery (ERAS) protocols.

Material methods: After Ethics Committee approval (2020/965), the data of 90 patients who underwent elective orthognathic surgery, were investigated. Following standard monitorization and general anesthesia; Group 1 patients were applied traditional approach and received intraoperative 10 mL/kg/h IV izolen infusion. Group 2 received ERAS approach. Patients in Group 2 did not preoperatively smoke for 48 hours, drank clear liquids until the last 2 hours, and received 6 mL/kg/h IV izolen intraoperatively. In these; gastric aspiration was also applied before extubation, PONV prophylaxis and patient controlled analgesia was added to the routine plans for the first postoperative 48 hours. The primary endpoint was length of hospital stay. The secondary endpoints were intraoperative follow-up data, length of postanesthesia care unit (PACU) stay, numeric rating scale (NRS) pain scores, opioid consumption and PONV incidences through the postoperative first 48 hours, and satisfaction scores.

详细描述

Aim: Orthognathic surgeries are extensive surgeries including both soft and hard tissues of the facial region of the skull associated with blood loss, inflammatory reactions, massive swelling, postoperative nausea vomiting (PONV), and severe pain. Therefore; in most of the patients who are with dentofacial deformity and undergo orthognathic surgery, postoperative recovery generally requires a long troublesome period. The aim of this study is to improve postoperative outcome by the use of Enhanced Recovery After Surgery (ERAS) protocols.

Material methods: After Ethics Committee approval (2020/965), the data of 90 patients who underwent elective orthognathic surgery, were investigated. Following standard monitorization and general anesthesia; Group 1 patients were applied traditional approach and received intraoperative 10 mL/kg/h IV izolen infusion. Rescue analgesics and PONV prophylaxis were applied when required through the postoperative first 48 hours. Group 2 received ERAS approach. Patients in Group 2 did not preoperatively smoke for 48 hours, drank clear liquids until the last 2 hours, and received 6 mL/kg/h IV izolen infusion intraoperatively. In these; gastric aspiration was also applied before extubation, PONV prophylaxis was supported routinely, and patient controlled analgesia was added to the routine analgesia plan for the first postoperative 48 hours. The primary endpoint was length of hospital stay. The secondary endpoints were intraoperative follow-up data, numeric rating scale (NRS) pain scores, opioid consumption, PONV incidences, length of postanesthesia care unit (PACU) stay, satisfaction scores of two groups through the postoperative first 48 hours.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing orthognathic surgery (bimaxillary, mandibular/maxillary)
  • Patients aged between 18 and 40 years of age
  • American Society of Anesthesiologists (ASA) physical status of 1-2
  • Capable of understanding the instructions for using the NRS pain scores
  • Capable of replying the study-based questions
  • Absence of mental/psychiatric disorders
  • Absence of chronic analgesic/opioid use
  • Absence of alcohol/illicit drug use
  • Exclusion Criteria
  • Patients who are younger than 18 years of age
  • Patients who are older than 45 years of age
  • American Society of Anesthesiologists (ASA) physical status of 3-4
  • Not capable of consenting
  • Not capable of understanding the instructions for using the NRS pain
  • Not capable of replying the study-based questions
  • Presence of mental/psychiatric disorders
  • Presence of chronic analgesic/opioid use
  • Presence of alcohol/illicit drug use

排除标准

  • 未提供

结局指标

主要结局

Length of hospital stay

时间窗: 0-48 hours

Post Anaesthetic Discharge Scoring System (PADSS) (≥9/10)

次要结局

  • Patient satisfaction(0-48 hours)
  • Surgeon satisfaction(0-48 hours)
  • Intraoperative fentanyl requirement(0-5 hours)
  • Mean arterial pressure (MAP)(0-5 hours)
  • Pain (Numeric rating scale (NRS)) scores(0-48 hours)
  • Heart rate(0-5 hours)
  • Length of stay in postoanesthesia care unit (PACU)(0-1 hours)
  • The amount of blood loss(0-5 hours)
  • Postoperative first oral intake(0-24 hours)
  • The difference of preoperative-postoperative haemoglobin values(0-12 hours)
  • Postoperative first passage of flatus or stool(0-24 hours)
  • Opioid (meperidine) consumption(0-48 hours)
  • Incidence of postoperative nausea and vomiting (PONV)(0-48 hours)
  • Postoperative first mobilization(0-24 hours)

研究者

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

Emine Aysu Salviz, MD

MD, Attending Anesthesiologist, Associate Professor

Istanbul University

研究点 (1)

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