Dexamethasone Preoperative for Patients Undergoing Laparoscopy for Suspected Appendicitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 119
- 试验地点
- 2
- 主要终点
- Postoperative nausea and vomiting (PONV)
研究概览
简要总结
For elective abdominal surgery preoperative administration of 8 mg dexamethasone reduces the incidents of postoperative nausea and vomiting (PONV). Whether preoperative administration of 8 mg dexamethasone reduces PONV for patients having acute abdominal surgery has not been established. The investigators wish to see if preoperative administration of 8 mg dexamethasone minimum 30 minutes prior to a diagnostic laparoscopy for suspected appendicitis will reduce the incidents of PONV by 50%. Of secondary interest the investigators want to see if 8 mg dexamethasone preoperative can reduce pain, reduce opioid consumption, postoperative fatigue, duration of time until resumption of work and resumption of normal daily activities, and enhanced the quality of recovery.
详细描述
Eligible patients undergoing a diagnostic laparoscopy for suspected appendicitis will be randomized to receive placebo or 8 mg dexamethasone intravenously minimum 30 minutes prior to the operation.
Randomization will be done by envelope randomization. We would expect that 60% of the patients would experience postoperative nausea or vomiting (PONV) during the first 24-32 hours postoperatively. To show a 50% reduction in the incidents of PONV during the first 24-32 hours postoperatively (with a power of 80%, a significant level of 5% and a loss to follow up of 20%) we need 60 patients in each arm. So a total of 120 patients are to be randomized 1:1.
Both sites use paper Case Report Forms (CRF). The trial will be monitored by the regional GCP (Good Clinical Practice) unit and adhere to GCP guidelines.
Patients are assessed by self reporting questionnaires preoperatively and postoperatively after 2-10 hours, 8-16 hours, 24-32 hours, on postoperative day (POD) 2, POD 3, POD 7, POD 14 and POD 30.
Preoperative anxiety recorded by a VAS scale, Pain Catastrophizing Scale and Hospital anxiety and depression scale are recorded by the preoperative questionnaire.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled for a diagnostic laparoscopy for suspected appendicitis
- •ASA clas I-III
排除标准
- •Known inflammatory bowel disease
- •Known autoimmune disease.
- •Chronic pain patient.
- •Pregnant or breastfeeding.
- •In treatment with systemic corticoid steroids or immune-depressants.
- •Known glaucoma.
- •Known ocular herpes simplex.
- •Vaccination within 14 days prior to inclusion.
- •Known cushing's disease.
- •Known myasthenia gravis.
- •Presumably poor compliance with study protocol.
研究组 & 干预措施
Placebo
Injection of 2 ml isotonic NaCl intravenously minimum 30 minutes preoperative.
干预措施: Isotonic NaCl (Drug)
dexamethasone
Injection of 2 ml 4 mg/ml dexamethasone phosphate intravenously minimum 30 minutes preoperative.
干预措施: dexamethasone phosphate (Drug)
结局指标
主要结局
Postoperative nausea and vomiting (PONV)
时间窗: 24-32 hours postoperative
Incidents of nausea and/or vomiting during the first 24-32 hours postoperative
次要结局
- Pain at rest (VAS scale)(POD30)
- Pain when coughing (VAS scale)(POD30)
- Postoperative fatigue (VAS scale)(8-16 hours postoperative)
- Quality of recovery (QoR-15D questionnaire)(POD30)
- Time until resumption of normal daily activities(Registration when resumption, expected to be within 60 days postoperatively)
- Time until resumption of work(Registration when resumption, expected to be within 60 days postoperatively)
- Sleep quality (VAS scale)(POD30)
- Postoperative complications (Clavien-Dindo classification of surgical complications)(30 days postoperative)
- Duration of admission(30 days)
- PONV(24-32 hours postoperatively)
- Postoperative fatigue (VAS scale(POD30)