The Use of Preoperative Oral Dexamethasone to Improve Quality of Recovery After Breast Surgery

University of Manitoba1 个研究点分布在 1 个国家目标入组 80 人开始时间: 2014年8月最近更新: 2014年9月9日

适应症

干预措施

试验速览

阶段: 2 期
发起方: University of Manitoba
入组人数: 80
试验地点: 1
主要终点: Change from baseline in Quality of recovery at Post operative day 1 (POD1)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Randomized controlled trial of pre-operative oral dexamethasone vs placebo for the improvement of quality of recovery from surgery. The study population is limited to breast surgery patients. The investigators will also look at the effect of our intervention on post operative nausea and vomiting.

Patients will be recruited before the date of their surgery and will complete the Quality of Recovery-40 (QOR-40) questionnaire before their surgery and at 24 hours post op. They will also complete a Clinically significant nausea and vomiting score upon discharge from the post anesthesia recovery room, repeated at 24 hours post op.

详细描述

Design: This will be a single centre randomized, double blind, parallel-group, intention to treat, controlled trial. Patients are randomly assigned to pre-operative oral dexamethasone or placebo

Group 1: Pre-operative oral dexamethasone (10mg-2 hours pre-induction) Group 2: Placebo Sample Size: 80 patients (80% power to detect a difference of 10 points in our primary endpoint)

Study duration: 8 months

Primary endpoint: Quality of recovery at 24 hours post operation, as measured on the QoR-40 Secondary endpoints: Clinically significant nausea and vomiting on discharge from Post-Anesthesia Recovery Room (PARR) and at 24 hours.

Study hypotheses:Pre-operative oral dexamethasone will improve patient quality of recovery compared to placebo.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围: 18 Years 至 80 Years（Adult, Older Adult）
性别: Female
接受健康志愿者: 否

入选标准

•Adults (18 to 80 years of age) undergoing general anesthesia for elective breast surgery (lumpectomy or mastectomy) and providing informed consent.
•American Society of Anesthesia (ASA) class I, II, & III patients

排除标准

•ASA class IV and V patients
•Pregnancy
•History of allergy to any study medications
•Use of steroids or anti emetics within 1 month of surgery
•Chronic pain requiring opioid treatment
•History of alcohol or drug abuse (including smoking tobacco)
•Severe renal impairment (i.e. serum creatinine more than 160 umol/L)
•Poor English comprehension or psychiatric/central nervous system disturbance that would preclude completion of the QoR-40 questionnaire

研究组 & 干预措施

Oral Dexamethasone

Active Comparator

Oral dexamethasone- two 4mg tabs and one 2mg tab contained within a gelatin capsule Administered a single time, 2 hours pre-induction