THE EFFICACY AND SAFETY OF INTRAVENOUS NEFOPAM HYDROCHLORIDE AS POSTOPERATIVE ANALGESIC IN GERIATRIC PATIENTS UNDERGOING LOWER LIMB ORTHOPAEDIC SURGERIES UNDER SPINAL ANAESTHESIA.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- To evaluate degree of pain relief and to determine duration of analgesia of Nefopam hydrochloride.
研究概览
简要总结
- Following approval from institutional ethical committee, informed consent will be taken from 96 geriatric participants of American SocietyofAnaesthesiologists (ASA) Physical status 1 and 2 undergoing elective lower limb surgeries under spinal Anesthesia.
A thorough pre anaesthetic evaluation will be done 24 hours prior to the procedure.
Patients will be premeditated with Tab.Pantoprazole 40mg and Tab. Alprazolam 0.5 mg. On the morning of study, all patients will have an IV access secured before spinal anaesthesia.After connecting multi parameter monitors with ECG,pulse oximetry and non invasive blood pressure ( NIBP ), basal parameters will be recorded.Spinal anaesthesia with 25G Quinckes spinal needle using Inj.Bupivacaine 2.5 ml (0.5%) H andInj fentanyl 25 mcg will be given in sitting posture and then patient is changed to supine posture. Hemodynamic parameters - PR, BP, SPO2 will be monitored at 15 minute intervals till the end of the surgery.
After the patient is shifted to postoperative ward, NRS scores are assessed. If NRS> 4 is recorded, Inj Nefopam 20 mg in 100ml saline will be started over 30 mins. Following which PR, BP, SPO2 , RR will be monitored at 0,10,20,30 minute intervals and any adverse events will be noted. The next doses of nefopam will be given once a NRS score of 4 is recorded thereafter till 24 hours.
In spite of giving nefopam, if patients complains of pain within 24 hours of administering the drug Inj. Tramadol 50mg IV will be given at NRS more than or equal to 4. At the end of 24 hours,the total rescue analgesic requirement will be calculated.
Every time after the drug is given , degree of pain relief and duration of analgesia of nefopam hydrochloride postoperatively will be recorded along with the variations in hemodynamic parameters and adverse effects in elderly people.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 60.00 Year(s) 至 85.00 Year(s)(—)
- 性别
- All
入选标准
- •Asa 1/2 Undergoing lower limb orthopaedic surgeries under spinal anaesthesia.
排除标准
- •Patients undergoing emergency surgeries, patients with renal and hepatic insufficiency , patients with convulsive disorders and on MAO-inhibitor drugs , patients having it’d and those with cognitive dysfunction.
结局指标
主要结局
To evaluate degree of pain relief and to determine duration of analgesia of Nefopam hydrochloride.
时间窗: Postoperatively when NRS score is 4 and 4th hourly till 24 hours.
次要结局
- To assess the rescue analgesic requirement , variations in hemodynamic parameters and to study adverse effects of nefopam in elderly people.(Postoperatively when NRS score is 4 and 4th hourly till 24 hours.)
