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临床试验/NCT02305173
NCT02305173已完成3 期

Effect of the Preoperative Administration of Dexamethasone in the Respiratory Function and Postoperative Symptoms in Women Undergoing Mastectomy for Cancer. Results of a Randomized Clinical Trial.

Instituto Mexicano del Seguro Social1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2014年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
120
试验地点
1
主要终点
Change in Forced Vital Capacity (FVC), measured in Liters/second and in percentage %.

研究概览

简要总结

Preoperative dexamethasone reduces symptoms after different surgical procedures including mastectomy in breast cancer, but the effect in the postoperative respiratory function remains unknown. The aim of this protocol was to determine if the administration of a single dose of dexamethasone during the preoperative, could improve respiratory function and postoperative symptoms of patients undergoing mastectomy in breast cancer.

详细描述

Controlled clinical trial will be performed in 120 surgical patients treated for breast cancer, conducted from Nov 2014 to Nov 2015. Patients will be divided in three groups: Group 1 consisted in patients who underwent conservative breast with axillary lymph node dissection, group 2 in patients with radical mastectomy without reconstruction, and group 3 patients with radical mastectomy with immediate reconstruction with synthetic breast implants.

All patients will be randomly assigned by a system of sealed envelopes, to receive 8 mg of intravenous dexamethasone or placebo 60 minutes before surgery. All patients will be female and had a confirmed diagnosis of breast carcinoma. The investigators will exclude patients with a classification of the American Society of Anesthesiologists classes III and IV. Other exclusion criteria are: age 80 years, pregnancy or during menstruation, during steroid therapy, severe diabetes mellitus (serum HbA1c> 8%); opioids, sedatives or painkillers less than a week before the mastectomy, or a history of alcohol or drugs. The investigators will exclude patients with a history of inner ear disease and / or severe PONV after any surgical procedure performed in the past. All patients will be admitted to hospital one day before surgery and were followed from hospital admission and until 30 days after surgery for any medical or surgical morbidity.

Anesthesia and surgery

All patients will be standardized to the next anesthetic protocol:

Under venipuncture, patients receive 1 g of Cephalothin IV one hour before starting the procedure. After entering the operating room, type 1 continuous monitoring was placed via noninvasive, Midazolam will be administered via peripheral 0.1-0.2 mg/kg as well as fentanyl 1 mcg / kg IV. Prongs will be placed and basal hemodynamic values will be taken with preoxygenation by tidal volume technique per minute.

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
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
20 Years 至 69 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • confirmed diagnosis of breast carcinoma

排除标准

  • patients with a classification of the American Society of Anesthesiologists classes III and IV.
  • pregnancy
  • during menstruation
  • during steroid therapy
  • severe diabetes mellitus (serum HbA1c> 8%)
  • opioids, sedatives or painkillers less than a week before the mastectomy
  • history of alcohol or drugs
  • patients with a history of inner ear disease and / or severe PONV after any surgical procedure performed in the past

研究组 & 干预措施

dexamethasone group

Active Comparator

patients receive one single dose of intravenous dexamethasone 8 mg.

干预措施: Intravenous Dexamethasone (Drug)

placebo group

Placebo Comparator

patients receive one single dose of intravenous placebo.

干预措施: intravenous salin water (Drug)

结局指标

主要结局

Change in Forced Vital Capacity (FVC), measured in Liters/second and in percentage %.

时间窗: change occurred from 1 hour before surgery and after 1, 6, 12 and 24 postoperative hours

maximum amount of air a person can expel from the lungs after a maximum inhalation.

Change in Forced Espiratory Volume (FEV) in the first second, measured in Liters/second and in percentage %.

时间窗: change occurred from 1 hour before surgery and after 1, 6, 12 and 24 postoperative hours

Measures the amount of air a person can exhale during a forced breath in one second.

Change in Peak Respiratory Flow (PRF). measured in Liters/second and in percentage %.

时间窗: change occurred from 1 hour before surgery and after 1, 6, 12 and 24 postoperative hours

A person maximum speed of expiration

次要结局

  • Change in pain occurred from 1 hour before surgery and after 1, 6, 12 and 24 hours after surgery.(change occurred from 1 hour before surgery and after 1, 6, 12 and 24 postoperative hours)
  • Total dose of backup analgesic medication administrated to each patient(24 hours after surgery)
  • Total dose of backup antiemetic medication administrated to each patient(24 hours after surgery)
  • Morbidity after mastectomy(24 postoperative hours and until 8 days after surgery after hospital discharge.)
  • Change in Oximetry (percentage %).(change occurred from 1 hour before surgery and after 1, 6, 12 and 24 postoperative hours)
  • Change in nausea occurred from 1 hour before surgery, and after 1, 6, 12 and 24 hours after surgery.(change occurred from 1 hour before surgery and after 1, 6, 12 and 24 postoperative hours)
  • Change in vomiting occurred from 1 hour before surgery, and after 1, 6, 12 and 24 hours after surgery.(change occurred from 1 hour before surgery and after 1, 6, 12 and 24 postoperative hours)

研究者

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

GONZALEZ-OJEDA ALEJANDRO

Alejandro González-Ojeda, Ph.D., M.D.

Instituto Mexicano del Seguro Social

研究点 (1)

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