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临床试验/NCT02382146
NCT02382146已完成4 期

A Prospective Randomize Study: Prevention of Nausea and Vomiting in Plastic Surgery

Yeditepe University Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2012年4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
发起方
入组人数
60
试验地点
1
主要终点
prevention of postoperative nausea and vomiting

研究概览

简要总结

We designed this randomized, double- blind, single-center study to compare the efficacy of the combination of dexamethasone with ondansetron and dexamethasone with dimenhydrinate undergoing plastic surgery.

详细描述

A total of 60 voman patient, ASA status I-II , aged 18-65 year and scheduled for elective rhinoplasty were enrolled in the study. Exclusion criterias hypersensitivity or contraindication for the studied medications, received an antiemetic drug or steroid within 24 hours before anesthesia, have history of diabetes history of motion sickness (MS) or PONV, or pregnant and lactating females.

Patients were informed on how to use the patient controlled analgesia device during the postoperative period. The risk criterias for PONV were recorded for each patient.Patients were randomly assigned to two study groups of 30 patients. All patients were premedicated with intravenous (iv) midazolam (1-2 mg). On arrival in the operating room, standard anesthetic monitors were applied. Anesthesia was induced with iv propofol (2-3 mg/kg) and fentanyl (1-1.5 μg/kg). Tracheal intubation was facilitated with rocuronium (0.6 mg/kg). After tracheal intubation all patient received iv 8 mg dexamethasone. Normocapnic mechanical ventilation was performed after intubation. General anesthesia was maintained with sevoflurane (1 minimum alveolar concentration) in oxygen / air mixture and remifentanil (0.1-0.3 μg/kg/min) infusion.Four mg ondansetron and for each patient 1 mg/kg dimenhydrinate in the 5 ml syringe solution were prepared by pharmacy department, and given to the blinded investigators. The patients, anesthesiologists (with the exception of the primary author), statistician, and observes were all blinded.

Dimenhydrinate was administered in group DD (1mg/kg), and ondansetron was administered in group DO (4mg), and all patients received tramadol (1.5mg/kg) and tenoksikam (20mg) half an hour before emergence.

Postoperative analgesia was provided with a patient controlled analgesia system by using iv tramadol (5mg/mL) (2 ml bolus and 10 minutes lockout interval without basal infusion).

After the surgery, muscle relaxation was reversed by administering neostigmine (0.05mg/kg) and atropine (0.015mg/kg). Patients were extubated and transferred to the recovery unit.

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 (Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • 18 Years to 60 Years woman
  • ASA (American Society of Anesthesiologist) physical status I or II
  • Patients undergoing laparoscopic gynecologic surgery or laparoscopic cholecystectomy

排除标准

  • Hypersensitivity or contraindication to the study medications,
  • Antiemetic drug or steroid use within 24 hours before anesthesia,
  • History of diabetes mellitus,
  • History of motion sickness or postoperative nausea and vomiting,
  • Breast feeding

研究组 & 干预措施

dexamethasone and ondansetron

Experimental

dexamethasone 8 mg with ondansetron 4mg administered in group DO

干预措施: dexamethasone ondansetron (Drug)

dexamethasone and dimenhydrinate

Active Comparator

dexamethasone 8 mg with dimenhydrinate 1mg/kg administered in group DD

干预措施: Dexamethasone dimenhidrinate (Drug)

结局指标

主要结局

prevention of postoperative nausea and vomiting

时间窗: 1 year

The primary outcome is complete response: complete response is defined as no postoperative nausea (VRS≤3), retching or vomiting and no need for rescue antiemetic.

次要结局

未报告次要终点

研究者

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

nurcan kizilcik

Dr.

Yeditepe University Hospital

研究点 (1)

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