A Multicenter Randomized Trial to Evaluate the Efficacy and Safety of Three Different Prophylactic Treatments of Postoperative Nausea and Vomiting in Patients Undergoing Vitrectomy Under Local Anesthesia
试验速览
- 阶段
- 4 期
- 入组人数
- 1,200
- 试验地点
- 4
- 主要终点
- • Proportion of patients with Complete Response (no nausea, no vomiting, no retching, and no use of rescue medication) during the first 24 hours after surgery
研究概览
简要总结
Vitreoretinal surgery is associated with a considerable incidence of postoperative nausea and vomiting (PONV), which is reported to be as high as 60%. Reasons for this high incidence may be the long duration of surgery and anesthesia and the high degree of manipulation of the eye. Postoperative vomiting after vitrectomy is an important risk factor for the onset of several complications, such as suprachoroidal hemorrhage, with disastrous visual consequences.
To date there is no evidence as to the possible protective effect of anti-emetic therapy with regard to interventions of vitrectomy performed under local anesthesia.
In this prospective, randomized, multicenter, double blind study, we evaluated the efficacy of Ondansetron alone, Dexamethasone alone and in combination in controlling nausea and vomiting in patients undergoing vitrectomy under local anesthesia.
详细描述
Patients were randomly stratified to receive 1 of 4 prophylactic antiemetic treatments (3 pharmaceutical treatment and 1 placebo) in a double-blind manner at the start of the surgery and 15 minutes before the end of surgery.
The syringes were prepared by a third, neutral person not involved in the perioperative care of the patient, immediately before the start of anesthesia.
All vitrectomy surgeries were performed, in each unit,under local anesthesia by a retrobulbar block.
Each patients was observed and treated during a period of 24 hours after the surgery. For patients who have nausea and vomiting despite the antiemetic prophylaxis, will be given a rescue dose of 4 mg ondansetron IV.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 or older with an American Society of Anesthesiologists (ASA) physical status of I to II
- •Scheduled for vitrectomy under local anesthesia
排除标准
- •Hypersensitivity to study drug or rescue medication
- •Preoperative score for nausea greater than 4 out of 10 points
- •Subjects who suffer from chronic nausea and/or vomiting
- •Severe hepatic insufficiency (Child-Pugh score > 9)
- •Other antiemetic within 12 hours prior to surgery
- •Patients unable to undergo a local anesthetic
- •Subjects with clinically significant or unstable cardiac, respiratory, hepatic, renal, or other major organ system disease
- •Psychotic illness or depression
- •Addiction to illicit substances or alcohol
- •Non-psychotic emotional disorders
- •Pregnant or lactating
- •Subjects who, in the opinion of the investigator, would experience an unacceptable risk from administration of study drug
研究组 & 干预措施
PLACEBO Group
Received normal saline
干预措施: PLACEBO (Drug)
DEXAMETHASONE Group
Received 4 mg Dexamethasone.
干预措施: Dexamethasone (Drug)
ONDANSETRON
Received 4 mg Ondansetron
干预措施: Ondansetron (Drug)
DEXAMETHASONE + ONDANSETRON
Received 4mg Dexamethasone + 4mg Ondansetron
干预措施: Dexamethasone + Ondansetron (Drug)
结局指标
主要结局
• Proportion of patients with Complete Response (no nausea, no vomiting, no retching, and no use of rescue medication) during the first 24 hours after surgery
时间窗: 1-24 hours post-operatively
次要结局
- • Standardized score of nausea and/or vomiting severity if PONV occurs.(1-24 hours post-operatively)
- • Pain score during the immediate post-operative period.(1-24 hours post-operatively)
- • Number of antiemetic rescue medications given postoperatively.(1-24 hours post-operatively)
- • Rates of known side effects.(1-24 hours post-operatively)
研究者
REIBALDI MICHELE
Professor
University of Catania