Conscious Sedation Efficacy of the Novel Medication, MKO Melt (Midazolam, Ketamine, Ondansetron), During Cataract Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 651
- 试验地点
- 1
- 主要终点
- Number of patient who needed additional IV medication for cataract surgery
研究概览
简要总结
The investigators hypothesized that the combination of Valium, Tramadol and Zofran is superior to the substantially more expensive MKO melt in patient satisfaction after cataract surgery.
详细描述
The MKO melt is being marketed as an anesthetic medication for cataract surgery that has the advantage that it eliminates the need for an IV in 85% of patients although that number was established anecdotally. This alternative, however, is very cost limiting.The investigators wanted to see if the current regimen (valium only) or a combination similar to the MKO melt (valium + tramadol + zofran) are as good if not better than the MKO melt for anesthesia and how many patients could have indeed gone with an intravenous line (didn't need any extra medications).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
盲法说明
The surgeon was not aware which medication the patient received
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients scheduled to undergo cataract surgery with Drs. Mayo and Wade at Kirby Glen Surgery Center
排除标准
- •Age <18 years
- •Patient is not suitable for the medications for reasons such as unsteady gait, cane, wheelchair, severe dementia (unable to consent), terminal illness
- •Allergy to a medication in protocol
研究组 & 干预措施
diazepam only (group 1)
Patients are given 5 or 10mg of diazepam for sedation before surgery for sedation
干预措施: Diazepam (Drug)
diazepam/tramadol/ondansetron (group 2)
Patients are given 5 or 10mg of diazepam, 50 or 100mg of tramadol and 4 or 8mg of ondansetron orally before surgery for sedation
干预措施: Diazepam (Drug)
diazepam/tramadol/ondansetron (group 2)
Patients are given 5 or 10mg of diazepam, 50 or 100mg of tramadol and 4 or 8mg of ondansetron orally before surgery for sedation
干预措施: Tramadol (Drug)
diazepam/tramadol/ondansetron (group 2)
Patients are given 5 or 10mg of diazepam, 50 or 100mg of tramadol and 4 or 8mg of ondansetron orally before surgery for sedation
干预措施: Ondansetron (Drug)
MKO only (group 3)
Patients are given 1 or 2 MKO melts (each contain 3mg midazolam, 25mg ketamine, 2mg ondansetron) sublingually before surgery for sedation
干预措施: MKO melt (Drug)
结局指标
主要结局
Number of patient who needed additional IV medication for cataract surgery
时间窗: 1 day
Patients who require IV medications for self-reported pain or anxiety during surgery.
次要结局
未报告次要终点
研究者
Maggie Jeffries
Principal Investigator
Avanti Anesthesia