INTRANASAL DEXMEDETOMIDINE FOR POSTOPERATIVE ANALGESIA IN GERIATRIC PATIENTS UNDER GOING LOWER LIMB ORTHOPEDIC SURGERIES
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
- The objective is to study the efficacy of intranasal dexmedetomidine as postoperative analgesia in geriatrics patients after lower limb orthopedic surgeries,To study the VAS scores in the 24 hr post op period, To study the analgesic consumption in the 24 hr post op period.
研究概览
简要总结
All patients will undergo a pre anaesthetic evaluation to ensure safe anaesthetic planning and perioperative care. This will include a detailed history of chronic illnesses such as hypertension, diabetes, asthma, and cardiac conditions, along with prior surgeries, previous anaesthetic exposure, hospital admissions, and any known drug allergies. A complete physical examination will be conducted to assess the patient’s general condition. Baseline vital parameters including heart rate, blood pressure, respiratory rate, mean arterial pressure, and body mass index will be recorded. Systemic examinations of the respiratory, cardiovascular, central nervous, and vertebral systems will be performed. Airway assessment will include Mallampati grading, mouth opening, neck mobility, dentition, and thyromental distance.
Subarachnoid block will be administered using three millilitres of zero point five percent hyperbaric bupivacaine under strict aseptic precautions. Intraoperatively, heart rate, non invasive blood pressure, mean arterial pressure, oxygen saturation, and respiratory rate will be continuously monitored. Postoperatively, patients will be observed in the post anaesthesia care unit until recovery, and vitals will be recorded. Pain will be assessed using the Visual Analogue Scale ranging from zero to ten. If the Visual Analogue Scale score exceeds four, intravenous paracetamol fifteen milligrams per kilogram will be administered. Patients will be randomized into two groups, D and C. Both groups will receive intranasal medication using a mucosal atomizer. The D group will receive dexmedetomidine zero point six micrograms per kilogram which is one millilitre, while the C group will receive one millilitre of normal saline. The study will be conducted in a double blinded manner. Parameters such as heart rate, respiratory rate, non invasive blood pressure, mean arterial pressure, oxygen saturation, and Visual Analogue Scale will be recorded at baseline, fifteen minutes, thirty minutes, forty five minutes, one hour, two hours, four hours, six hours, twelve hours, and twenty four hours. Sedation will be assessed every two hours using the modified Richmond Agitation Sedation Scale which ranges from plus four, which is combative, to minus five, which is unarousable, with zero indicating alert and calm. This study design allows a safe evaluation of intranasal dexmedetomidine for postoperative sedation and analgesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 65.00 Year(s) 至 90.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients aged 65 years and above, Patients undergoing lower limb orthopaedic surgeries subarachnoid blockade, Patients with ASA grading 1,2.
排除标准
- •Known hypersensitivity or allergy to dexmedetomidine , Patients receiving antidepressants, Contraindication for nasal drug administration ,nasal trauma or obstruction such a copious mucous, bleeding, anatomic, tumoral or foreign body obstruction ,Documented risk of respiratory distress recent within 7 days need to be ventilated, recent respiratory impairment with an increased degree of dyspnea or a recent tachypnea more than 20 mins, known sleep apnea without non-invasive, ventilation support, Documented cardiac risk ,congestive heart failure, known life-threatening heart rhythm or conduction disorders, bradycardia less than 60 bpm or atrioventricular block without pacemaker, systolic blood pressure less than 100 mmHg, digoxin treatment ,Recent stroke less than 1 month, Patients currently on beta blocker.
结局指标
主要结局
The objective is to study the efficacy of intranasal dexmedetomidine as postoperative analgesia in geriatrics patients after lower limb orthopedic surgeries,To study the VAS scores in the 24 hr post op period, To study the analgesic consumption in the 24 hr post op period.
时间窗: 15 min, 30 min, 45 mins, 1 hour, 2 hour, 4 hour , 6 hour, 12 hour, 24 hour
次要结局
- Hemodynamic effects,(agitation,anxiety,sedation in geriatric patients after undergoing lowerlimb orthopedic surgeries.)
研究者
UDUMULA ANUDEEPIKA REDDY
SHRI B.M. PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE
