The Effects of Preoperative Scopolamine Patch Application on the Postoperative Nausea and Vomiting in Microvascular Decompression Surgery
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 主要终点
- Change in Degree of nausea: Visual Analogue Scale (VAS)
研究概览
简要总结
A Single-center, randomized, prospective, experimental, double-blind comparison study for effects of preoperative scopolamine patch application on the postoperative nausea and vomiting in microvascular decompression surgery
详细描述
- Study design and plan
1-1) Sixty envelopes will be prepared: Thirty envelopes of scopolamine patch for experimental group and 30 of placebo patch for control group. Each envelope will be tagged for QR code, randomly mixed and numbered from 1 to 60. QR code will be identified after discontinuation of study, so both researchers and subjects would not know in which group the envelope is belonged to.
1-2) Patch will be applied under the ear of the opposite side of operation, at 9 p.m. of the day before the operation day.
1-3) Nausea will be assessed by Visual Analogue Scale (VAS) immediate after arrival at a recovery room and the ward. After that, nausea will be continuously assessed every 4 hour (4hr, 8hr, 12hr, 16hr, 20hr, and 24hr after surgery) and a number of vomiting will also be counted. Basic clinical characteristics and the number of antiemetic administration will be identified through medical records. 2. Efficacy assessment
2-1) Degree of nausea: Visual Analogue Scale (VAS) Subjects will describe their subject degree of nausea by VAS score, just immediate after arrival at a recovery room or the ward and 4hr, 8hr, 12hr, 16hr, 20hr, and 24hr after surgery. Respondents specify their degree of nausea by indicating a point along a continuous 10cm line between two end-points; left one is for "No nausea" and the right one for "Very severe nausea". Scoring is based on the length from left point and higher score means more severe degree of nausea.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Those of either hemi-facial spasm or trigeminal neuralgia, who undergo microvascular decompression (MVD), understand study objectives and voluntarily consent with participation.
- •Adequate communication ability enough to understand and answer the questionnaire.
- •Age ≥ 18 years, and ≤ 65 years.
- •ASA Physical Status Classification from 1 to
- •Class 1: A normal healthy patient Class 2: A patient with mild systemic disease
- •Those who is discharged to general ward, not intensive care unit (ICU) after operation
- •Normal liver or kidney function
排除标准
- •More than one craniotomy in the same period of admission
- •Pregnant or lactating women
- •Narrow-angle glaucoma
- •Pyloric stenosis, intestinal obstruction, bladder obstruction
- •Bradycardia
- •Voiding difficulty such as benign prostate hypertrophy (BPH)
- •Any history of hypersensitivity to ointment base or scopolamine patch
研究组 & 干预措施
Placebo group (P group)
The group that not existed scopolamine ingredient.
dosage form: apply
dosage: 1.5 mg
frequency: 1 times (at 9 p.m. of the day before the operation day)
duration: Until the 24hr after operation.
Patients will be applied patch that not existed scopolamine ingredient.
干预措施: Placebo (Drug)
Scopolamine group (S group)
'Scopolamine (1.5mg) 1 patch'
The group that existed scopolamine ingredient
dosage form: apply
dosage: 1.5 mg
frequency: 1 times (at 9 p.m. of the day before the operation day)
duration: Until the 24hr after operation.
Patients will be applied patch that existed scopolamine ingredient.
干预措施: Scopolamine (Drug)
结局指标
主要结局
Change in Degree of nausea: Visual Analogue Scale (VAS)
时间窗: just immediate after arrival at a recovery room or the ward and 4hr, 8hr, 12hr, 16hr, 20hr, and 24hr after surgery
Subjects will describe their subject degree of nausea by VAS score, just immediate after arrival at a recovery room or the ward and 4hr, 8hr, 12hr, 16hr, 20hr, and 24hr after surgery. Respondents specify their degree of nausea by indicating a point along a continuous 10cm line between two end-points; left one is for "No nausea" and the right one for "Very severe nausea". Scoring is based on the length from left point and higher score means more severe degree of nausea.
次要结局
未报告次要终点
研究者
Jung Ho Han
Associate Professor
Seoul National University Hospital