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临床试验/NCT03338400
NCT03338400已完成2 期

Dexamethasone Administration To Improve Patient Recovery In Ambulatory Vaginal Reconstructive Surgery: Is There A Role?

The Cleveland Clinic1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2017年5月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
51
试验地点
1
主要终点
Questionnaire: Quality of Recovery 40

研究概览

简要总结

To the investigators knowledge there are no studies in the literature evaluating the effect of Dexamethasone administration on patients undergoing outpatient vaginal prolapse surgeries.

详细描述

The lifetime risk of undergoing surgical intervention for pelvic organ prolapse (POP) is estimated to be 10% and it is projected that from 2010 to 2050, the number of surgeries for POP will rise by 47.2%, from 166,000 to 245,970. In 1980, accounting for the rising costs of health care, congress approved Medicare to reimburse procedures performed at outpatient and ambulatory surgery centers. This led to an increasing number of stress incontinence (SUI) procedures being performed in the ambulatory setting from 34,968 in 1996 to 105,656 in 2006. However, the number of ambulatory POP surgeries decreased in the same time period. This was possibly due to the increase in the mean age of women undergoing ambulatory procedures for POP and SUI during that time periods.

At the investigator's institution has performed outpatient surgeries for POP and SUI for the past 3 years. Patients have tolerated same day surgery with minimal complications. In the investigator's previous prospective study assessing satisfaction after outpatient surgeries for POP and SUI, patients had a decreased quality of recovery at 48 hours compared to baseline. The investigators also recognized that nausea and pain control could have been better addressed. Unpleasant postoperative nausea and vomiting, pain control, return to normal voiding and return of bowel function can influence the quality of recovery (QOR) from surgery.

Postoperative nausea and vomiting (PONV) and pain management are particularly troubling for the patients. This might also delay discharge and prolong convalescence from the surgery.

Several safe interventions have been assessed in the literature for alleviating PONV, pain and recovery from laparoscopic gynecologic surgery.

Dexamethasone is a potent corticosteroid that has been widely used for chemotherapy induced nausea and vomiting. The mechanism of action is not completely understood. It has been proposed that a single dose may hamper the production and release of anti-inflammatory mediators, thereby decreasing postoperative nausea, emesis, pain perception and Dexamethasone also has a central antiemetic effect by inhibition of prostaglandin and/or release of endogenous opioids. A recent metanalysis concluded that Dexamethasone administration at induction is safe.

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
Single (Participant)

入排标准

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

入选标准

  • Women over the age of 18
  • Women scheduled for vaginal POP reconstructive surgery with or without concomitant anti-incontinence procedure and with or without hysterectomy
  • ASA class 1-2

排除标准

  • Daily use of steroids, antiemetics in the month prior to surgery
  • Chronic pain requiring daily opioid treatment
  • History of allergy/intolerance to Dexamethasone
  • ASA class 3
  • Numerical Pain score of more than 4 at baseline
  • Renal/Liver disease
  • Diabetes mellitus
  • Inability to answer questionnaires
  • Any systemic infections
  • Immuno compromised status
  • Patients with planned overnight stay

研究组 & 干预措施

Dexamethasone

Active Comparator

Patients in the Dexamethasone arm will be administered the drug at the time of induction.

干预措施: Dexamethasone (Drug)

Normal Saline

Placebo Comparator

The placebo arm patients will receive normal saline at the time of induction.

干预措施: Normal saline (Drug)

结局指标

主要结局

Questionnaire: Quality of Recovery 40

时间窗: 24 hours

The primary aim is to evaluate whether standard administration of Dexamethasone at the time of anesthesia induction in patients undergoing vaginal reconstructive surgery would result in improved Quality of Recovery. The QoR-40 has 40 items that consider early postoperative health status of patients. These items cover five dimensions including emotional state (9 items), physical comfort (12 items), patient support (7 items), physical independence (5 items) and pain (7 items). All items are rated on a five-point Likert scale from one (worst) to five (best). All negative items were reversed to ease the interpretation. The total score (global score) was computed by summing all items. The minimum and maximum possible scores were 40 and 200, respectively.

次要结局

  • Urinary Tract Infections(until 6 weeks)
  • Pain Level(24 hours)
  • Nausea, Vomiting(24 hrs)
  • Readmissions(6 weeks)

研究者

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

Eric Hurtado

Principal Investigator

The Cleveland Clinic

研究点 (1)

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