CTRI/2023/11/059804尚未招募2/3 期
A prospective randomised comparative study of the effect of preemptive dose of oral Pregabalin versus oral Gabapentine on postoperative analgesia and total analgesic consumption in Radical Mastectomy under general anaesthesia.
Mysore medical College and research institute1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2023年11月19日最近更新:
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- To evaluate and compare the efficacy of single
研究概览
简要总结
It is a Comparative study to evaluate efficacy of preemptive dose of oral Pregabalin versus oral Gabapentine
on the duration of postoperative analgesia in patients undergoing elective Modified Radical Mastectomy under general anaesthesia
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 and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Female
入选标准
- •All ASA grade I and II patients between 18 to 60 years age group with carcinoma breast posted for elective Modified Radical Mastectomy surgeries will be recruited for the study after obtaining written informed consent.
排除标准
- •Patients with Cardiovascular, Respiratory, Renal and Neurological disorders Patients with coagulation abnormalities Patients with chronic pain conditions and taking analgesics Obesity (BMI>30kg/m2) Patients with history of psychiatric disorders or on anti-psychotic drugs Patients on oral anticoagulants, anti-epileptic drugs, opioids Patients with history of alcohol abuse Any known drug allergy to the study drugs.
结局指标
主要结局
To evaluate and compare the efficacy of single
时间窗: 24 hours
preemptive dose of oral Pregabalin versus oral
时间窗: 24 hours
Gabapentine on the duration of postoperative
时间窗: 24 hours
analgesia and total analgesic consumption in
时间窗: 24 hours
patients undergoing elective Modified Radical Mastectomy under general anaesthesia
时间窗: 24 hours
次要结局
- To record the intraoperative hemodynamic(changes at specified intervals with Pregabalin and)
研究者
Vaishnavi S G
Mysore medical College and research institute
研究点 (1)
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