The Effect of Propofol Versus Dexmedetomidine on the Incidence of Postoperative Nausea and Vomiting in Ureteroscopic Procedures Under Spinal Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- primary outcome
研究概览
简要总结
Post-operative nausea and vomiting are a leading cause of recovery room delays and low patient satisfaction. Complications such as suture line tension, wound hemorrhage and dehiscence, elevated intracranial pressure, pulmonary aspiration, dehydration, and electrolyte imbalance have been linked to nausea and vomiting.
Many studies were done to explore the effects of propofol and dexmedetomidine on the incidence of post operative nausea and vomiting (PONV). In this study, we will compare propofol infusion to dexmedetomidine infusion on the incidence of PONV in patients undergoing ureteroscopic procedures under spinal anesthesia in the age group from 18 to 60 years with more than one risk factor for PONV (female, history of PONV, non-smoking).
详细描述
In regional anesthesia, the mechanism of postoperative nausea and vomiting through the effect of hypotension is extremely common. Low blood pressure can cause ischemia in the brain stem, which activates the medulla's circulatory, respiratory, and vomiting centers. According to some researchers, hypotension causes gut ischemia and the release of emetogenic chemicals (such as serotonin) from the intestines. The function of the gastrointestinal tract is similarly altered by neuraxial anesthesia. Local anesthetics suppress the sympathetic nervous system, resulting in unopposed vagal action and gastrointestinal hyperactivity. The effectiveness of vagolytic drugs in relieving nausea during spinal anesthesia has been cited as proof of the mechanism's importance. During regional anesthesia, visceral discomfort is a powerful stimulator of emetic symptoms. Handling abdominal viscera stimulates sensory vagal fibers and activates the vomiting center, causing emesis.
Although the specific mechanism by which propofol operates as an antiemetic is unknown, a central mechanism for propofol's antiemetic activity appears to be the most likely, and a peripheral antiemetic effect has also been considered.
Because of its broad range of effects, which include anxiolytic, sedative, analgesic, anesthetic-sparing, sympatholytic, and hemodynamic-stabilizing qualities, dexmedetomidine is a powerful 2-adrenergic agonist with prospective applications in clinical anesthesia. The use of dexmedetomidine as an anesthetic adjuvant intraoperative has resulted in significant reductions in the use of opioids and inhalation anesthetics, as well as a decrease in the incidence of emergence agitation, a favorable recovery profile, and a decrease in postoperative pain without adverse hemodynamic effects.
The aim of this study is to compare the effects of dexmedetomidine infusion to propofol infusion during spinal anesthesia, on the incidence of postoperative nausea and vomiting in patients undergoing ureteroscopic procedures under spinal anesthesia.
Participants will be adults aged 18 to 60 years, scheduled for ureteroscopic procedures under spinal anesthesia.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged 18 to 60 years
- •ASA physical status I-II
- •Scheduled for ureteroscopic procedure
- •With more than one Risk factor for PONV (female, history of PONV, non-smoking).
排除标准
- •Patients with contraindications for spinal anesthesia including infection at the injection site, bleeding diathesis, known left ventricular outflow obstruction, hypovolemia, and increased intracranial pressure.
- •History of allergy or hypersensitivity to propofol or dexmedetomidine.
- •Gastrointestinal diseases e.g. gastroenteritis and gastric ulcers, ear diseases e.g. infections of middle and inner ear, liver cirrhosis.
- •Those who have received antiemetic drugs within 48 hours before surgery.
- •Operations lasting more than two hours.
- •The patient's unwillingness.
研究组 & 干预措施
Propofol group
will receive propofol infusion.
干预措施: Propofol (Drug)
Dexmedetomidine group
will receive dexmedetomidine infusion.
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
primary outcome
时间窗: 6 hours
Number of PONV episodes in patients undergoing ureteroscopic procedures under spinal anesthesia
次要结局
- secondry outcome(2 hours)
- tertiary outcome(2 hours)
研究者
Beshoy Atef Nagiub
Principal Investigator
Cairo University