Dexmedetomidine for Prophylaxis Against Postoperative Nausea and Vomiting in Highly Susceptible Patients: a Randomised Controlled Comparison of Two Bolus Doses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Incidence of PONV in the 1st 24 hours postoperatively
研究概览
简要总结
The study aims to compare between two bolus doses of dexmedetomidine in preventing PONV in highly susceptible patients.
详细描述
Being A challenging complaint, many studies tried to find an effective preventive strategies for PONV. In this study protocol the investigators aim to compare between 0.5 mic/kg and 0.75 mic/kg bolus doses of dexmedetomidine when given toward the end of head and neck surgeries in highly susceptible patients with a controlled group receiving ondansetron.
The primary outcome is the 1st 24 hours incidence of PONV
Other outcomes include:
- Time to 1st call for rescue antiemetic and the total amount of antiemetics
- Number of PONV attacks
- Post operative pain score with visual analogous scale (VAS) and time to 1st call for rescue analgesia
- Sedation Score using Observer's Assessment of Alertness and sedation (OAA/S)
- Patient satisfaction
- Vital signs in the 1st 24 hours
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Two risk factors or more for PONV ( female, non-smoking, postoperative opioids, history of motion sickness or PONV )
- •Head and neck surgeries in adults
- •ASA ( I , II )
排除标准
- •Patients on ( steroids , antiemetics or any drug caude emesis )
- •Any active cardiac condition at the time of the surgery
- •Pregnancy
研究组 & 干预措施
Dexmedetomidine 0.5 mic/kg bolus
selective alpha 2 adrenergic receptor agonist
干预措施: Dexmedetomidine Hydrochloride 0.5 mic/kg bolus (Drug)
dexmedetomidine 0.75 mic/kg bllus
selective alpha 2 adrenergic receptor agonist
干预措施: Dexmedetomidine Hydrochloride 0.75 mic/kg bolus (Drug)
Placebo group
receving equal volume of normal saline
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of PONV in the 1st 24 hours postoperatively
时间窗: The first 24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours )
The overall incidence of nausea and vomiting in the 1st 24 hours following Head and neck surgeries.
次要结局
- Patient satisfaction(The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours ))
- Number of PONV attacks(The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours ))
- Pain score postoperatively.(The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours ))
- Sedation score(The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours ))
- Blood pressure(The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours ))
- The time to 1st call for rescue antiemetic(In the 1st 24 hours)
- Heart Rate (HR)(The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours ))
- Total amount of morphine consumption(The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours ))
- The time to 1st call for rescue analgesia(In the first 24 hours)
- The severity of nausea.(The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours ))
研究者
Amr Raafat Mahmoud Seif
Principal Investigator
Cairo University