Comparison of Dexmedetomidine and Dexamethasone as an adjuvant to ondansetron for prevention of postoperative nausea vomiting in patients undergoing elective spine surgery- A Randomised Double blind Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Grade of Post operative nausea vomiting
研究概览
简要总结
The incidence of Post operative nausea vomiting (PONV) is especially high in high risk patients, one of them being patients undergoing spine surgery. Multimodal therapy with a combination of antiemetics like 5 HT3 antagonists combined with phenothiazines, antihistamines and steroids is the preferred modality for PONV prevention in high risk patients. Recently the effect of dexmedetomidine , an alpha 2 agonist, has been the focus of clinical researches. we aimed to evaluate the efficacy of dexmedetomidine when used as an adjuvant to ondansetron for PONV and compare it with dexamethasone ondansetron combination. After getting institutional ethical committee clearance, 100 patients of age group 18 to 70 years will be enrolled in the study. After standard induction,intubation and positioning the patient prone, the study group will receive either 5 ml saline bolus followed by Inj dexmedetomidine infusion continued throughout the period of surgery or Inj Dexamethasone 0.1 mg/kg as 5 ml bolus follwoed by saline infusion throughout the surgery. The anaesthetist blinded to the study will be recording the hemodynamics (HR, MAP) , total dose of opioid and inhalational agent received intraoperatively. After reversal and extubation, patients will be shifted to recovery and followed up every four hours for 24 hours for the presence of PONV and the total rescue antiemetic received.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •All patients aged 18-70 years belonging to ASA 1 and 2 undergoing elective spine surgery under general anaesthesia.
排除标准
- •Any allergy/hypersensitivity to the study medication.
- •Patients with BMI > 30 kg/m2 3)Patients for emergency spine procedures.
- •Patients who received opioid, antiemetics or any steroid therapy 24 hrs prior to surgery.
- •Patients had episode of nausea, vomiting or retching in the 24 hrs prior to anaesthesia.
- •Patients with history of GERD.
结局指标
主要结局
Grade of Post operative nausea vomiting
时间窗: Grade of PONV will be recorded | at | 0 hrs/Baseline (immediate post surgery) | 4 hrs | 8 hrs | 12 hrs | 16 hrs | 20 hrs | 24 hrs
(Grade 0: no nausea and no retching
时间窗: Grade of PONV will be recorded | at | 0 hrs/Baseline (immediate post surgery) | 4 hrs | 8 hrs | 12 hrs | 16 hrs | 20 hrs | 24 hrs
Grade 1: complaining of sickness or retching
时间窗: Grade of PONV will be recorded | at | 0 hrs/Baseline (immediate post surgery) | 4 hrs | 8 hrs | 12 hrs | 16 hrs | 20 hrs | 24 hrs
Grade 2: vomiting one or two times in 30 minutes
时间窗: Grade of PONV will be recorded | at | 0 hrs/Baseline (immediate post surgery) | 4 hrs | 8 hrs | 12 hrs | 16 hrs | 20 hrs | 24 hrs
Grade 3: vomiting more than two times in 30 minutes
时间窗: Grade of PONV will be recorded | at | 0 hrs/Baseline (immediate post surgery) | 4 hrs | 8 hrs | 12 hrs | 16 hrs | 20 hrs | 24 hrs
次要结局
- 1. Mean arterial pressure (MAP)and Heart rate (HR).(2.Dose of additional Inj fentanyl administered)
