Assessing The Safety and Efficacy of Ondansetron, Dexamethasone, and Their Combined Regimen in Managing Post Operative Nausea and Vomiting: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Incidence of Postoperative Nausea and Vomiting (PONV)
研究概览
简要总结
This randomized controlled trial aims to evaluate the safety and efficacy of Ondansetron, Dexamethasone, and their combination in managing postoperative nausea and vomiting (PONV) in patients undergoing surgery under anesthesia. A total of 100 patients will be randomized into four groups: Placebo, Ondansetron, Dexamethasone, and Ondansetron-Dexamethasone combination. The primary outcome will be the incidence of PONV within 24 hours post-surgery, while secondary outcomes include severity of symptoms, need for rescue medication, adverse effects, and patient satisfaction.
详细描述
Postoperative nausea and vomiting (PONV) is a common and distressing complication following surgery, affecting patient recovery and satisfaction. This study aims to compare the safety and effectiveness of Ondansetron, Dexamethasone, and their combination for PONV prevention.
The study will be conducted as a randomized, controlled trial at Federal Polyclinic Hospital Islamabad over four months. A total of 100 adult patients undergoing elective surgery under anesthesia will be enrolled and randomly allocated into one of four groups (n=25 each):
Placebo group - Receives no prophylactic antiemetic treatment. Ondansetron group - Receives 4 mg IV Ondansetron before surgery. Dexamethasone group - Receives 8 mg IV Dexamethasone before surgery. Ondansetron-Dexamethasone group - Receives 4 mg IV Ondansetron + 8 mg IV Dexamethasone before surgery.
Methodology:
Patients will be assessed at multiple time points (2, 4, 6, 12, and 24 hours postoperatively) for PONV incidence and severity, along with the need for rescue medication. Side effects such as headache, dizziness, hypertension, and hyperglycemia will also be monitored.
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 (Participant)
盲法说明
This study will be single-blinded, meaning that the patients will not be aware of their assigned treatment group, but the healthcare provider administering the medication will know.
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
- •Adult patients (≥18 years) scheduled for elective surgery under anesthesia.
- •Patients at moderate to high risk for postoperative nausea and vomiting (PONV), as determined by an Apfel risk score ≥
- •Patients able to provide informed consent or have a legally authorized representative provide consent.
排除标准
- •Known allergy or hypersensitivity to Ondansetron, Dexamethasone, or any of their components.
- •History of significant adverse reactions to previous PONV prophylaxis with Ondansetron or Dexamethasone.
- •Pre-existing conditions or medications contraindicating the use of Ondansetron or Dexamethasone, e.g. QT prolongation or severe cardiac arrhythmias (e.g., torsades de pointes, congenital long QT syndrome), Uncontrolled hypertension (for Dexamethasone use), Severe hepatic impairment (Child-Pugh C) or end-stage renal disease, Uncontrolled diabetes mellitus (due to Dexamethasone-induced hyperglycemia).
- •Patients with active malignancy undergoing chemotherapy or radiotherapy.
- •Pregnant or lactating women (unless safety in this population is specifically being studied).
- •Chronic opioid users (≥3 months of continuous opioid use), as this may alter PONV risk and response to prophylaxis.
研究组 & 干预措施
Arm 1: Placebo Group (Control)
Patients in this group will receive a placebo (normal saline) intravenously before surgery. This group serves as a control to compare the efficacy and safety of the active treatment regimens.
干预措施: Placebo (Normal Saline) (Drug)
Arm 2: Ondansetron Group
Patients in this group will receive a single dose of Ondansetron 4 mg IV before surgery. Ondansetron is a 5-hydroxytryptamine type 3 receptors antagonist commonly used for postoperative nausea and vomiting prevention.
干预措施: Ondansetron (Zofran) (Drug)
Arm 3: Dexamethasone Group
Patients in this group will receive a single dose of Dexamethasone 8 mg IV before surgery. Dexamethasone is a corticosteroid that has been shown to reduce postoperative nausea and vomiting.
干预措施: Dexamethasone (Drug)
Arm: 4 Combination Therapy Group
Patients in this group will receive a combination of Ondansetron 4 mg IV and Dexamethasone 8 mg IV before surgery. The combination therapy is expected to have an additive effect in reducing PONV.
干预措施: Ondansetron (Zofran) (Drug)
Arm: 4 Combination Therapy Group
Patients in this group will receive a combination of Ondansetron 4 mg IV and Dexamethasone 8 mg IV before surgery. The combination therapy is expected to have an additive effect in reducing PONV.
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Incidence of Postoperative Nausea and Vomiting (PONV)
时间窗: 24 hours
Defined as the presence of nausea and/or vomiting at any assessment time point (recovery, 2, 4, 6, 12, and 24 hours postoperatively). Comparison of postoperative nausea and vomiting incidence between the Ondansetron-Dexamethasone and Ondansetron groups. The need for rescue antiemetic administration as an indicator of postoperative nausea and vomiting severity.
次要结局
- Severity of Postoperative Nausea and Vomiting (Postoperative Nausea and Vomiting Impact Scale Score)(24 hours)
- Postoperative Pain Scores (Visual Analog Scale Score)(24 hours)
- Need for Rescue Medication(24 hours)
- Adverse Effects of Medications(24 hours)
- Satisfaction with Postoperative Nausea and Vomiting Management(24 hours)
- Apfel Score: Risk Assessment for Postoperative Nausea and Vomiting (PONV)(24 hours)
- Heart Rate(24 hours)
- Blood Pressure(24 hours)
- Respiratory Rate(24 hours)
- Oxygen Saturation(24 hours)
研究者
Hafiz Muhammad Hamza
House Officer, Foundation University School of Health Sciences
Federal Government Polyclinic (Postgraduate Medical Institute)