Efficacy of intravenous ketamine after spinal anesthesia on post-operative pain
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- VAS Score
研究概览
简要总结
After approval from the institutional ethics committee, study will be conducted in 60 ASA I and ASA II fit patients scheduled for surgeries under spinal anaesthesia aged between 18 to 60 years of age, hemodynamically stable and with informed consent. 60 patients equally divided into group N and group K in which group N receives normal saline intravenously and group K receives ketamine intravenously. Preoperative pulse, non-invasive blood pressure, ECG and oxygen saturation will be noted. Peripheral venous access will be established and intravenous (IV) fluids will be given, preloading will be with 10ml/kg of Ringer‟s lactate. The spinal anaesthesia will be given in the sitting position with due aseptic precautions. After painting and draping of the lumbar area, 2% xylocaine will be infiltrated in L3-L4 intervertebral space and a 26 G Quincke‟s spinal needle will be introduced. CSF free flow will be confirmed and intrathecal Inj. Bupivicaine 3ml(15mg) will be given. The patient will be placed supine position immediately and will be administered 2 litres of oxygen via a venture mask. Ascent of the sensory block will be checked by pin prick method. Motor blockade will be checked with bromage scale. 10minutes after spinal anaesthesia Inj.Midazolam 1mg will be given followed by study drug
l Group (N) – 30 cases (5ml normal saline intravenously )
l Group (K) – 30 cases (0.25mg/kg of Inj.ketamine diluted upto 5ml with normal saline intravenously)
All the vitals such as heart rate, mean arterial pressure,blood pressure,spo2will be noted at 1min, 5mins and every 10mins after drug injection until the end of surgery
Any other side effects such as tachycardia, bradycardia, hypotension, nausea, vomiting, pruritis, headache will be noted and treated accordingly. Post-operatively visual analogue scale score (VAS) and sedation score will be noted every half hourly.
During the postoperative period, patients will be given Inj. Diclofenac 75mg i.m. stat on demand for rescue analgesia when the pain score is more than 5 on the basis of the Visual Analog Scale. Subsequent rescue analgesics will be given more than 5or more than 5. Time of administration of the rescue analgesic will be noted and chart will be maintained.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients with ASA grade 1 or 2 Patients with all routine investigations within normal limits and with no comorbidities Availability of informed consent.
排除标准
- •patients with ASA grade 3 and above Patients posted in emergency procedures Patients with major neurological, cardiac, respiratory, metabolic, renal, hepatic diseases Patients with allergies to study drug.
结局指标
主要结局
VAS Score
时间窗: 24hours
Sedation score
时间窗: 24hours
次要结局
- Duration of analgesia(12hours)
