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临床试验/NCT01052038
NCT01052038已完成4 期

The Effect of Systemic Prophylactic Dexamethasone on the Incidence of Postoperative Sore Throat in Patients Undergoing Ambulatory Laparoscopic Gynecologic Surgery: A Prospective, Randomized, Double Blinded, Placebo Controlled Trial

Northwestern University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2010年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
120
试验地点
1
主要终点
Subjects Assessment of Sore Throat Pain at 24 Hours

研究概览

简要总结

Sore throat is a common postoperative complaint that can lead to morbidity and patient dissatisfaction . The incidence of sore throat has been reported to be between 6% and 90% even under optimal intubating conditions. There are several factors that have been shown to contribute to postoperative sore throat such as patient related factors, type of anesthesia and type of surgery.

Corticosteroids are also commonly used in the perioperative period to potentiate analgesics and as antiemetics. The preoperative administration of dexamethasone can decrease the incidence and severity of postoperative sore throat which is rated by patients as one of the most undesirable outcomes in the postoperative period.

详细描述

Sore throat is a common postoperative complaint that can lead to morbidity and patient dissatisfaction. The incidence of sore throat has been reported to be between 6% and 90% even under optimal intubating conditions. There are several factors that have been shown to contribute to postoperative sore throat such as patient related factors, type of anesthesia and type of surgery. It has been observed that gargle with azunol reduced the incidence of postoperative sore throat from 65% to 25 %. Similarly, a reduction in sore throat following tracheal intubation from 78% to 40 % has been reported after gargle with ketamine performed 5 minutes before induction of anesthesia. More recently, it was also demonstrated that preoperative gargle with licorice resulted in a 57 percent reduction of the absolute risk of sore throat after intubation. Although the gargling technique has been shown to be successful in decreasing the incidence of postoperative sore throat, it has a limited feasibility because the volumes administered could increase the chance of aspiration if ingested and it may be difficult to perform in sedated patients and in children.

Tracheal intubation is associated with an increase of polymorphonuclear cells in the tracheal tissue and plasma levels of interleukin 6, suggesting an inflammatory response to the presence of the endotracheal tube itself or to some aspect of the intubation process. Dexamethasone is widely prescribed for the treatment of a sore throat resulting from tracheal mechanical irritation due to its modulating effects of tissue edema and pain. Moreover, prophylactic dexamethasone has been shown to be effective in reducing the frequency of airway obstruction in patients at high risk for laryngeal edema following extubation. It decreases postoperative sore throat in patients requiring double-lumen tubes.

Dexamethasone has been shown to decrease postoperative sore throat in patients requiring hospital admission but it has not been evaluated in the ambulatory setting. Ambulatory patients usually need to return to work faster than patients who are admitted to the hospital. Their ability to tolerate fluids and food might help them to return to normal living. They also have smaller surgeries which might increased their perception to sore throat pain when compared to bigger, more painful procedures.

Possible side effects of corticosteroids such as retardation of wound healing, susceptibility to infection and gastrointestinal hemorrhage have not been noted with short term use (<24 hours ) in surgical patients. Corticosteroids are also commonly used in the perioperative period to potentiate analgesics and as antiemetics.

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, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Female patients undergoing outpatient laparoscopic gynecologic surgery
  • ASA PS I and II
  • Age between 18 and 64 years
  • Fluent in English

排除标准

  • History of recent respiratory tract infection
  • Pregnancy, breastfeeding
  • Current treatment with analgesics
  • Current use of corticosteroids
  • Anticipated difficult intubation
  • Risk factors for post-operative aspiration

研究组 & 干预措施

Group 1 Placebo

Placebo Comparator

Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery.

干预措施: Placebo administration (Drug)

Group 2: Dexamethasone 0.05mg/kg

Active Comparator

Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery

干预措施: Dexamethasone 0.05mg/kr administration (Drug)

Group 3:Dexamethasone 0.1mg/kg

Active Comparator

Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery.

干预措施: Dexamethasone 0.1mg/kg (Drug)

结局指标

主要结局

Subjects Assessment of Sore Throat Pain at 24 Hours

时间窗: 24 hours

The reported score for sore throat on a 1 to 5 scale where 1 is a severe sore throat and 5 is no sore throat. This evaluation was made by investigator initiated phone conversation at 24 hours following surgery.

次要结局

  • Quality of Recovery at 24 Hours(24 hours)
  • Number of Subjects With Sore Throat at 3 Hours Post Surgery.(3 hours.)
  • Opioid Consumption at 24 Hours(24 hours)
  • Hoarseness at 24 Hours(24 hours)

研究者

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

Gildasio De Oliveira

Gildasio De Oliveira, M.D. Principal Investigator

Northwestern University

研究点 (1)

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