A double blind randomized comparative controlled study of efficacy and duration of analgesia for Intrathecal Ketamine & S-Ketamine in Surgeries for Lower Abdomen or other Lower Extremities
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- 1.Postoperative abilities over time 2.Discharge time according to fixed criteria 3.Consumption of analgesics and anti emetics
研究概览
简要总结
This Study is a double blind randomized comparative controlled study of efficacy and duration of analgesia for Intrathecal Ketamine & S-Ketamine in Surgeries for Lower Abdomen or other Lower Extremities on 200 patients at three(3) sites in India. the primary outcomes & secondary outcomes are Primary Outcome Measures: 1.Postoperative abilities over time 2.Discharge time according to fixed criteria 3.Consumption of analgesics and anti emetics Secondary Outcome Measures: 4.Degree of nursing requirements 5.General tolerability of the regimes 6.Threshold for sensory perception and pain using the Pain Matcher device, pre- and postoperatively 7.A modified Bromage score should be used to measure motor block.
研究设计
- 分配方式
- Random Number Table
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
入选标准
- •1.Patients(Male or Female) undergoing Surgeries for Lower Abdomen or other Lower Extremities2.ASA GRADE I/II/III3.Age between 30-60 years 4.Body mass index < 35 kg/m2.
排除标准
- •1.Patients with respiratory, cardiac dieses, liver, kidney, neurological disorder2.Diabetes , hypertension3.Psychiatric disorder4.Infection on back5.Coagulation disorder?Raised intracranial tension.
结局指标
主要结局
1.Postoperative abilities over time 2.Discharge time according to fixed criteria 3.Consumption of analgesics and anti emetics
时间窗: 1.Postoperative abilities over time 2.Discharge time according to fixed criteria 3.Consumption of analgesics and anti emetics
次要结局
- 1.Degree of nursing requirements 2.General tolerability of the regimes3.Threshold for sensory perception and pain using the Pain Matcher device, pre- and postoperatively4.A modified Bromage score should be used to measure motor block.(After the injection, followed by every 2 min for the first 15 min and every 5 min thereafter throughout the surgery and until the complete reversal of analgesia and motor blockade occurs.)