Trimebutine Maleate (NEWBUTIN SR 300 mg Tab) as a Prophylactic Anti-emetic Drug for Patients Who Underwent Arthroscopic Rotator Cuff Repair: a Randomized Controlled Study
试验速览
- 阶段
- 3 期
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Severity of nausea after taking Trimebutine Maleate as a prophylactic medication
研究概览
简要总结
This study will determine if giving Trimebutine Maleate (NEWBUTIN SR 300 mg Tab)orally will be effective as a prophylactic anti-emetic drug for patients who underwent arthroscopic rotator cuff repair under general anesthesia.
详细描述
The patients will be divided in two groups using a computer generated randomization software. The first will be the MACPERAN group (controlled) and the other will be the NEWBUTIN group (variable). The controlled group will be treated with post-operative regimen in accordance with the standard protocol of the Chungmu Hospital, MACPERAN(Metoclopramide hydrochloride monohydrate 8.46 mg/2ml/A) thru IV twice in a day while the variable group will be given a single dose of NEWBUTIN SR 300 mg Tab orally one hour prior to the said operation time and another 300 mg orally as soon as the patient wakes post operatively.
A clinical research coordinator will monitor the patient until 48 hours post-operative. First time frame will be from 0-2 hours once patient is transferred to the ward followed by 2 hours to 24 hours and 24-48 hours post ward transfer. All patients will be assessed using the simplified risk score of Apfel et al. to determine who have the risk factors for PONV. The episodes of nausea and vomiting will be recorded taking note of its intensity and frequency on the said three time frames. Nausea is defined as a subjectively unpleasant sensation associated with an awareness of the urge to vomit; vomiting is defined as the forceful expulsion of gastric contents through the mouth. As retching is similar to vomiting in all aspects, except for the expulsion of gastric contents, it was considered as vomiting. The efficacy of anti-emetic medication (NEWBUTIN 300 mg/tab) will be assessed by monitoring the frequency and severity of nausea, vomiting, and PONV (which was regarded as the primary outcome). The severity of nausea will be graded on a four-point scale, where 0= no nausea, 1= mild nausea, 2= moderate nausea, and 3= severe nausea.Then the frequency will be assessed by monitoring how often the patient experienced these episodes (nausea and vomiting)during the said time frames.
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, Investigator)
入排标准
- 年龄范围
- — 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •post arthroscopic cuff repair patient previously diagnosed with small to large rotator cuff tear thru MRI
排除标准
- •above 70 years old
- •massive rotator cuff tear
研究组 & 干预措施
Trimebutine Maleate 300 mg Tab
A single dose of NEWBUTIN SR 300 mg Tab will be given orally one hour prior to the said operation time and another 300 mg orally as soon as the patient wakes post operatively.
干预措施: Trimebutine Maleate (NEWBUTIN SR 300 mg Tab) (Drug)
Metoclopramide hydrochloride monohydrate 8.46 mg/2ml/A
Anti-emetic medication protocol of Chungmu Hospital includes MACPERAN (Metoclopramide hydrochloride monohydrate 8.46 mg/2ml/A)thru IV twice in a day
干预措施: Metoclopramide hydrochloride monohydrate (Drug)
结局指标
主要结局
Severity of nausea after taking Trimebutine Maleate as a prophylactic medication
时间窗: 0-48 hours post rotator cuff repair
The severity of nausea will be graded on a four-point scale. 0- no nausea (can do all tasks). 1- mild nausea (can talk and answer questions appropriately,sit, stand but can't walk). 2- moderate nausea (can talk and but answer questions inappropriately, sit but can't stand and walk). 3- severe nausea (don't talk and answer questions, prefers lying down, cannot sit, stand and walk).
次要结局
- Frequency of PONV after taking Trimebutine Maleate as a prophylactic medication(0-48 hours post rotator cuff repair)
研究者
Sang-Hoon Lhee
Director of CM Chungmu Hospital
CM Chungmu Hospital