A study to compare the effects of 0.5 percent Hyperbaric levobupivacaine plain vs 0.5 percent Hyperbaric levobupivacaine with intrathecal Fentanyl for spinal anaesthesia in infra umbilical surgeries
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To compare the efficacy of intrathecal fentanyl as
研究概览
简要总结
The purpose of the study is to compare the effects of administration of intrathecal fentanyl as an
adjuvant to intrathecal hyperbaric 0.5 percent levobupivacaine versus administration of only intrathecal Hyperbaric 0.5 percent levobupivacaine, assessing for onset, the duration of effect of spinal and motor block in spinal anesthesia , hemodynamic stability ,
effect on duration of anesthesia , effects on duration of analgesia and side effects if any occur.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant 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
- •Patient willing to sign the written & informed consent.
- •Patients belonging to American Society of anesthesiologists grade I, II amd III 3) Patients with no history of allergy to opiods will be selected for the study.
- •Patients posted for infraumbilical surgeries.
排除标准
- •Patient’s refusal from taking part in the study.
- •Patients who have used any opioid or sedative medications in the week prior to surgery 3) Patients having history of drug abuse in the past.
- •Patient who have history of allergic reactions to bupivacaine or fentanyl.
- •Patient who have contraindication to spinal anaesthesia (e.g., coagulation defects, infection at puncture site, pre-existing neurological deficits in the lower extremities), and cardiovascular, respiratory, neurological, psychological, hepatic, or renal disease.
结局指标
主要结局
To compare the efficacy of intrathecal fentanyl as
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an adjuvant to hyperbaric 0.5 percent levobupivacaine and
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hyperbaric 0.5 percent levobupivacaine alone in onset and
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prolonging effects of spinal and motor block
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, hemodynamic stability, effect on duration of
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anaesthesia and post operative analesgia in
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patients receiving spinal anaesthesia in infra
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umbilical surgeries.
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次要结局
- To Assess VAS Score , Duration of Absolute &(effective analgesia, number of rescue analgesia)
研究者
Tanya Jaggi
Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre