Impact of Timing of Midazolam Administration on Incidence of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Gynecological Surgery; a Randomized Double-blinded Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Post Operative Nausea Vomiting assessment
研究概览
简要总结
Postoperative nausea and vomiting (PONV), defined as nausea and/or vomiting occurring within 24 hours after surgery, affects between 20% and 30% of patients, As many as 70% to 80% of patients at high risk may be affected. The etiology of PONV is thought to be multifactorial, involving individual, anaesthetic and surgical risk factors. PONV results in increased patient discomfort and dissatisfaction and in increased costs related to length of hospital stay. Serious medical complications such as pulmonary aspiration, although uncommon, are also associated with vomiting.
Patients with a higher risk of PONV often require a combination or multimodal approach of 2 or more interventions for effective risk reduction. Thus, researchers have explored additional nontraditional antiemetics, such as midazolam, that would aid in the multimodal prevention of PONV.
详细描述
Midazolam is often administered in the perioperative period to reduce anxiety in addition to causing sedation and amnesia. The pharmacologic qualities allow for a rapid onset, short duration, and short half-life. The clinical effects of midazolam result from an agonist action on the γ-aminobutyric acid A (GABAA) receptor throughout the central nervous system. Benzodiazepines do not work directly on the GABA receptor, so there is a physiologic ceiling effect, which contributes to their safety and low toxicity.
Although the exact antiemetic mechanisms remain unknown, researchers postulate that midazolam works on the chemoreceptor trigger zone by reducing the synthesis, release, and postsynaptic dopamine. It remains debatable whether midazolam reduces dopamine directly or blocks the reuptake of adenosine leading to an adenosine-mediated reduction of dopamine release. Additionally, the binding of midazolam to the GABA benzodiazepine complex may cause dopaminergic neuronal activity and the release of 5-hydroxytryptamine. The reduction of PONV may also be a secondary effect of the anxiolytic properties of benzodiazepines.
Despite literature demonstrating the PONV benefits of midazolam in the perioperative period, But the timing of administration of this drug is still not well established. As it is known that it has half-life of about 1.5 - 2.5 hours and the controversies remain whether to administer this drug preoperatively or postoperatively to prevent PONV. So this comparative study is designed to know the better time for administration of this drug to prevent PONV and to improve patient satisfaction.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female patients
- •aged twenty to sixty years old
- •The American Society of Anesthesiologists (ASA) physical status classification grade I or II
- •Scheduled for laparoscopic gynecological surgeries under general anesthesia.
排除标准
- •Patients who have gastrointestinal disorders,
- •histories of PONV after a previous surgery,
- •Renal or liver dysfunction,
- •history of motion sickness,
- •Have received any opioid, steroid, or antiemetic medication in the 24hs before surgery, and
- •Pregnant or menstruating women.
研究组 & 干预措施
Pre-induction Group (I)
will receive intravenous midazolam premedication 2mg in a volume of 3 ml, 15 minutes before induction of anesthesia
干预措施: Midazolam injection (Drug)
Pre-extubation Group (II)
will receive intravenous midazolam 2mg in a volume of 3 ml 30 minutes before extubation at the end of surgery
干预措施: Midazolam injection (Drug)
Control Group (III)
will receive 3 ml normal saline 15 minutes before induction of anesthesia plus 3 ml normal saline 30 minutes before extubation at the end of surgery.
干预措施: Midazolam injection (Drug)
结局指标
主要结局
Post Operative Nausea Vomiting assessment
时间窗: 24 hours postoperative
Nausea will be recorded according to the following scale: 0 none; 1 mild (patient able to eat); 2 moderate (oral intake significantly decreased); and 3 severe (no significant oral intake necessitating iv fluid). The absence of nausea will be defined as complete protection from nausea. An emetic episode will be defined as a single vomit or retch, or any number of continuous vomiting episodes or retches (one emetic episode should be separated from another by an absence of vomiting or retching for at least 1 min). The absence of emetic episodes will be defined as complete protection from vomiting.
次要结局
- Observer's Assessment of Alertness/ Sedation (OAA/S) scale(120 minutes postoperative)
- Pain intensity score(24 hours postoperative)
- requirements of rescue antiemetic(24 hours postoperative)
研究者
Samar Rafik Mohamed Amin
lecturer of anesthesia and surgical ICU
Benha University