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临床试验/NCT05752734
NCT05752734已完成不适用

Preoperative Dexamethasone Enhances Quality of Recovery After Laparoscopic Bariatric Surgery: A Prospective Observational Study

Ondokuz Mayıs University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年2月2日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Global Quality of Recovery (QoR-40) score in the first 24 hours after surgery

研究概览

简要总结

In the obese patient, adequate pain relief in the postoperative period is an important parameter that affects patient comfort and hospital stay. Increasing patient comfort and recovery quality can be achieved by avoiding undesirable effects such as nausea and vomiting, as well as analgesia. In our study, our aim is to evaluate the effect of dexamethasone added to multimodal analgesia on postoperative patient comfort in the obese patient group with a 40-item scale.

详细描述

Postoperative pain prolongs hospital stay, delays wound healing, increases infection rates, and increases the incidence of drug side effects due to the use of systemic pain relievers (especially opioids).

Good pain control facilitates respiratory effort, allows the patient to perform respiratory exercises and cough to correct the increased thoracic fat mass and impaired respiratory mechanics due to anesthesia. The patient without pain is mobilized early and discharged early.

Our aim is to evaluate the effect of dexamethasone added to multimodal analgesia on postoperative patient comfort in the obese patient group with a 40-item scale.

Patients will be divided in to two groups (group D and group C):

Group D (Dexamethasone Group):

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Body mass index>30 kg/m2
  • The American Society of Anaesthesiologists (ASA) physical status class I, II
  • The American Society of Anaesthesiologists (ASA) physical status class III only because of morbid obesity
  • Patients who will undergo an elective laparoscopic sleeve gastrectomy (LSG)
  • Those who are literate enough to answer the compilation quality score (QoR-40) questionnaire

排除标准

  • refusal to participate
  • allergy to the study drugs
  • chronic kidney disease (creatinine>150 μmol/L)
  • mental illness
  • liver, respiratory or oncological disease,
  • cardiac dysfunction (ejection fraction <40%),
  • uncontrolled hypertension,
  • preoperative analgesic use,
  • chronic pain,
  • history of alcohol or drug addiction

研究组 & 干预措施

Group D

Patients who used/applied dexamethasone before bariatric surgery were included in this group.

干预措施: Group D (Drug)

Group C

Patients who did not use dexamethasone or steroid-derived drugs were included in this group.

干预措施: Group C (Drug)

结局指标

主要结局

Global Quality of Recovery (QoR-40) score in the first 24 hours after surgery

时间窗: postoperative day 1

The recovery quality of the patients 24 hours after the operation will be evaluated with the QoR-40 questionnaire. The questionnaire consists of 40 questions that examine five domains of patient recovery using a five point Likert scale: none of the time, some of the time, usually, most of the time, and all of the time. The five domains include physical comfort, pain, physical independence, psychological support, and emotional state. As a result of the evaluation, the total score ranges from 40 (worst review quality score) to 200 (best review quality score).

The score for each of the five parameters that make up the QoR-40 questionnaire

时间窗: postoperative day 1

It consists of 5 parameters: physical independence score (n = 5), patient support score (n = 7), Physical comfort score (n = 12), emotional state score (n = 9) and pain score (n = 7).

次要结局

  • Morphine consumption in the first 24 hours after surgery(postoperative day 1)
  • The incidences of post-operative nausea and vomiting (PONV)(postoperative day 1)
  • Time to first mobilization(Up to 24 hours after surgery.)
  • Time to discharge(Trough hospital stay, an average of 1 week)

研究者

发起方
Ondokuz Mayıs University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yasemin Burcu Ustun

Professor

Ondokuz Mayıs University

研究点 (1)

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