CTRI/2025/07/090810尚未招募4 期
COMPARATIVE STUDY OF NALBUPHINE VS DEXMEDETOMIDINE AS ADJUVANT TO 0.75% HYPERBARIC ROPIVACAINE IN PATIENTS UNDERGOING LOWER LIMB SURGERIES UNDER SPINAL ANAESTHESIA
Bangalore Medical College and Research Institute1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年8月1日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Duration of effective analgesia (time from intrathecal injection to first request for rescue analgesia)
研究概览
简要总结
This is a prospective randomized controlled trial to compare the efficacy of intrathecal Nalbuphine and Dexmedetomidine as adjuvants to 0.75% hyperbaric Ropivacaine in patients undergoing lower limb surgeries under spinal anaesthesia. The study aims to evaluate duration of effective analgesia, onset and duration of sensory and motor block, hemodynamic parameter, incidence of adverse effects. A total of 60 adult patients will be enrolled and randomized into two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.ASA physical status I and II
- •Patients aged 18 to 65 years
- •Elective lower limb surgeries under spinal anaesthesia
- •Written informed consent obtained.
排除标准
- •1.Allergy to study drugs
- •Coagulopathy or anticoagulant therapy
- •Severe hepatic or renal or cardiac diseases
- •Local infection at injection site
- •Neurological deficits or spine deformities
- •Pregnancy or lactation
- •Refusal to participate.
结局指标
主要结局
Duration of effective analgesia (time from intrathecal injection to first request for rescue analgesia)
时间窗: At time of first request for rescue analgesia, up to 6 hours post intrathecal injection
次要结局
- Onset of sensory blockade(From intrathecal injection to loss of pinprick sensation at T12 dermatome)
- Onset and duration of motor blockade(Time to achieve Bromage score 3 and duration until return to score 0)
研究者
Dr Saima Z
Bangalore Medical College and Research Institute
研究点 (1)
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