A COMPARATIVE STUDY BETWEEN INTRATHECAL HYPERBARIC BUPIVACAINE 0.5 percent 3.0cc WITH NALBUPHINE 0.4 MILLIGRAM VERSUS HYPERBARIC BUPIVACAINE 0.5 percent 3.0 CC WITH FETANYL 25 MICROGRAM IN INFRAUMBILICAL 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
- This study aims to compare the efficacy of Fentanyl and nalbuphine used as an additive to bupivacaine in subarachnoid block to compare the hemodynamic response in infra-umbilical surgeries
研究概览
简要总结
THE PURPOSE OF THE STUDY IS TO COMPARE THE HEMODYNAMIC VARIABLE AND POST-OPERATIVE ANAGLESIA IN PATIENTS RECEIVING INTRA-THECAL NALBUPHINE AND FENTANYL AS AN ADDITIVE TO HYPERBARIC BUPIVACAINE IN BELOW UMBILICAL SURGRIES.
AIM:
Aim of this study is to compare the efficacy of Fentanyl and nalbuphine used as additive to bupivacaine in subarachnoid block in infraumbilical surgeries
Objectives:
TO COMPARE ONSET OF SENSORY AND MOTOR BLOCKADE
TO COMPARE DURATION OF SENSORY AND MOTOR BLOCKADE
COMPARE SEDATION OF PATIENT
TO COMPARE THE HAEMODYNAMIC CHANGES IN (PULSE RATE, BLOOD PRESSURE, OXYGEN SATURATION AND RESPIRATORY RATE)
TO COMPARE DURATION OF ABSOLUTE ANALGESIA AND EFFECTIVE ANALGESIA
TO COMPARE THE REQUIREMENT OF NUMBER OF RESCUE ANALGESIA
TO COMPARE THE SIDE EFFECTS/COMPLICATIONS IF any
Inclusion Criteria:
â— Patients willing to sign the informed written consent.
â— Patients of ASA Grade I and II of either gender.
â— Under Spinal anaesthesia for elective lower limb surgeries
â— Aged 18 - 60 years.
â— No known history of allergy, sensitivity to local anaesthetics of the amide group and other drugs used for this study.
Exclusion Criteria:
‘◠Patient refusal.
â— Patient not NIL by mouth.
â— History of seizure disorder.
â— Known allergy to trial drugs.
â— Patients with neurological disorders and neuropathies or receiving medications known to influence neuromuscular junction.
â— ASA III, IV, V Patients.
â— Patient with prior pre-existing Comorbidities (Heart diseases, Respiratory disease, Kidney diseases , known fetal abnormalities)
â— Pregnant females
â— Failed spinal anaesthesia converted to general anaesthesia
â— Any contraindication to Spinal Anaesthesia (local site infection, spine deformity, clotting abnormalities. Patients fulfilling above inclusion criteria are taken for study.
Method
After obtaining written informed consent, 60 patients planned for elective surgeries will be enrolled and grouped into Group-F & Group-N with 30 patients in each group.
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 are willing to sign the informed written consent. Patients of ASA Grade I and II of either gender. Under Spinal anaesthesia for elective BELOW UMBILICAL SURGERIES Age
- •60 years. No known history of allergy or 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.
- •Patients with prior pre-existing Comorbidities (Heart diseases, Respiratory diseases, Kidney diseases, known fetal abnormalities) Pregnant females Failed spinal anaesthesia converted to general anaesthesia.
- •Any contraindication to Spinal Anaesthesia (local site infection, spine deformity, clotting abnormalities.
- •Patients fulfilling the above inclusion criteria are taken for study.
结局指标
主要结局
This study aims to compare the efficacy of Fentanyl and nalbuphine used as an additive to bupivacaine in subarachnoid block to compare the hemodynamic response in infra-umbilical surgeries
时间窗: Hemodynamic response and Onset of Sensory and motor blockade asseses at | Baseline | 2min | 5 mins | 10 mins | 15 mins | 20 mins | 30 mins | 45 mins | 60 mins | 90 mins | 120 mins
次要结局
- to compare duration of Post-operative analgesia in group fentanyl & group nalbuphine(Post-operative Anaglesia)
研究者
Dr Kartik H Sangam
Smt. Bhikiben Kanjibhai Shah Medical Institute and research Centre
