Analgesic Effect of Preoperative Dexamethasone in Gynecological Laparotomies - a Dose-ranging Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Total cumulative morphine consumption via the patient-controlled analgesia (PCA) pump in the first 24 hours
研究概览
简要总结
The objective of the study is to examine the effect of the addition of intravenous dexamethasone 1.5 hours prior to induction of anesthesia on the post-operative opioid consumption, pain scores, fatigue, and recovery in patients undergoing gynecological surgery with laparotomy under general anesthesia.
This is a dose finding study with two different doses (0.1 mg/kg vs. 0.2 mg/kg) of dexamethasone to find out the optimal efficacious dose of dexamethasone with minimal side effects.
Dexamethasone has anti-inflammatory, immunomodulatory, and analgesic effects; and is superior to placebo in providing post-operative pain control, lower analgesic consumption, prevention of postoperative nausea and vomiting, lesser post-operative fatigue, and better recovery profile. No dose response study has been done. The investigators hypothesize that a higher dose of dexamethasone may have an incremental beneficial effect.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients must be non-lactating
- •18-65 years of age
- •ASA groups I-III for elective total abdominal hysterectomy (with or without salpingo-oophorectomy or minor bladder repair)or myomectomy through a lower transverse or low midline incision under general anesthesia. Incidental appendectomy and /or abdominal lipectomy were allowed as collateral surgical procedures if the same incision was used
排除标准
- •Emergent procedures
- •Diagnosed malignancy
- •History of allergy to dexamethasone
- •Allergy or contraindication to drugs used in study and anesthesia
- •Patients with uncontrolled diabetes mellitus, recent history of gastrointestinal bleeding or ulceration within 30 days before the study)
- •Patients who have taken drugs in the 12 hours preceding the surgery that could confound the analgesic response (specifically analgesics, neuroleptics, corticosteroids, NSAIDs)
- •Patients who have been on long term oral steroid therapy
- •Patients with BMI>40
- •Serious organ disease/ dysfunction
- •Chronic pain patients requiring >30mg morphine per day or equivalent
- •Severe psychiatric disease
- •Drug Addiction
- •Pregnancy
- •Language barrier
- •Inability to cooperate with the use of the intravenous PCA morphine pump
研究组 & 干预措施
Dexamethasone
干预措施: Dexamethasone (0.1 mg/kg) (Drug)
Dexamethasone
干预措施: Dexamethasone (0.2 mg/kg) (Drug)
Saline
干预措施: Saline (Other)
结局指标
主要结局
Total cumulative morphine consumption via the patient-controlled analgesia (PCA) pump in the first 24 hours
次要结局
- Total cumulative postoperative morphine consumption after 48 hours
- Time to first analgesic request in the PACU
- Numerical Rating Scale at rest (supine) and on movement (on sitting) at baseline, 1, 6, 12, 24 and 48 hours after surgery
- Total fentanyl administration intraoperatively and in the PACU
- Time to discharge from the PACU