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临床试验/CTRI/2020/04/024816
CTRI/2020/04/024816尚未招募不适用

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.

Dr Ramyavel Thangavelu1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年1月5日最近更新:

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)

研究者

发起方
Dr Ramyavel Thangavelu
申办方类型
Other [Principal Investigator]

研究点 (1)

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