A COMPARATIVE STUDY BETWEEN INTRATHECAL DEXMEDATOMEDINE VERSUS NALBUPHINE AS AN ADDITIVE WITH HYPERBARIC BUPIVACAINE IN LOWER LIMB ORTHOPAEDIC SURGERIES
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- to Compare efficacy of dexmedatomedine and nalbuphine in blunting hemodynamic response and post operative analesgia in patient recieving
研究概览
简要总结
INTRODUCTION:- Spinal anesthesia with hyperbaric bupivacaine 0.5%(heavy) is a popular method however there is a disadvantage of its short half-life. To overcome this disadvantage there is a constant search for an ideal adjuvant. Initially, opioids like fentanyl and buprenorphine were tried. Opioids reduce the toxicity and adverse cardiovascular effects of local anesthetics, however, this type of combination brings about additional undesirable problems like itching, nausea and vomiting and /or respiratory depression**.**
AIM:-,
Aim of this study is to compare the efficacy of Dexmedetomidine and Nalbuphine used as additive to bupivacaine in subarachnoid block in lower limb orthopedic surgeries
OBJECTIVES:-
TO COMPARE
Onset , duration of sensory and motor blockade
Sedation of patients.
The hemodynamic changes in (HR, BP, SpO2 and RR )
Duration of absolute analgesia and effective analgesia.
The requirement of a number of rescue analgesia.
The side effects/ Complications.
MATERIALS AND METHODOLOGY
All the patients aged between 20 to 60 years old belonging to the American Society of Anesthesiologists (ASA) grade I or II undergoing elective lower limb Orthopedic surgery will be taken for the study. Written and informed consent will be taken from all the selected patients.
Sunarachnoid Block Will be given in 2 different Groups of 30 each.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients willing to sign the informed written consent. Patients of ASA Grade I and II of either gender Under Spinal anaesthesia for elective pelvic and lower limb surgeries Aged
- •60 years. No known history of allergy, sensitivity to local anaesthetics of the amide group and other drugs used for this study.
排除标准
- •Patient refusal.
- •Patient not NIL by mouth.
- •History of seizure disorder.
- •Known allergy to trial drugs.
- •Patients with neurological disorders and neuropathies or receiving medications known to influence neuromuscular junction.
- •ASA III, IV, V Patients.
- •Patient with prior pre-existing Comorbidities (Heart diseases, Respiratory disease, Kidney diseases, known fetal abnormalities) Pregnant females Failed spinal anesthesia converted to general anesthesia Any contraindication to Spinal Anaesthesia (local site infection, spine deformity, clotting abnormalities.
- •Patients fulfilling above inclusion criteria are taken for study.
结局指标
主要结局
to Compare efficacy of dexmedatomedine and nalbuphine in blunting hemodynamic response and post operative analesgia in patient recieving
时间窗: to Compare efficacy of dexmedatomedine and nalbuphine in blunting hemodynamic response and post operative analesgia in patient recieving | Spinal anaesthesia in lower limb orthopedic surgeries | Baseline | 0 min | 2 mins | 5 mins | 10 mins | 20 mins | 30 mins | 45 mins | 60 mins | 90 mins | 120 mins | 150 mins | 180 mins
Spinal anaesthesia in lower limb orthopedic surgeries
时间窗: to Compare efficacy of dexmedatomedine and nalbuphine in blunting hemodynamic response and post operative analesgia in patient recieving | Spinal anaesthesia in lower limb orthopedic surgeries | Baseline | 0 min | 2 mins | 5 mins | 10 mins | 20 mins | 30 mins | 45 mins | 60 mins | 90 mins | 120 mins | 150 mins | 180 mins
次要结局
- to compare duration of post operative analgesia in group dexmedatomedine & group nalbuphine(time at which rescue analgesia was given)
研究者
Dr Kartik H Sangam
Smt. Bhikiben Kanjibhai Shah Medical Institute and research Centre