CTRI/2025/02/080174尚未招募2 期
Comparison of intrathecal fentanyl and dexmedetomidine as adjuvants to hyperbaric bupivacaine for elective gynecological surgeries : A double blind controlled study.
Department of Anaesthesiology1 个研究点 分布在 1 个国家目标入组 142 人开始时间: 2025年2月14日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- Duration of sensory and motor block and hemodynamic changes.
研究概览
简要总结
This trial will compare between two groups posted for electives gynecological surgeries, one receiving intrathecal dexmedetomidine and another group receiving intrathecal fentanyl as adjuvants to hyperbaric bupivacaine with respect to duration of block, intraoperative hemodynamic changes, onset time to reach peak motor and sensory block and postprocedural adverse effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •18-60 years female patients with physical status 1 and 2 according to the American Society of Anaesthesiologists(ASA).
- •Patients undergoing Total abdominal hysterectomy (TAH), Vaginal hysterectomy (VH) and Myomectomy.
- •Providing written informed consent.
排除标准
- •Patient refusal.
- •ASA grade 3 and
- •Emergency surgeries.
- •Patients with motor and/or sensory deficit.
- •5.Patients with anticipated difficult airway.
- •6.Patients having compromised cardiac,pulmonary,hepatic and renal functions.
- •Patients with seizure disorders.
- •Patients having coagulation disorders.
- •Localised skin infection at the site of injection.
- •Patients having known allergy to drugs used in this study.
结局指标
主要结局
Duration of sensory and motor block and hemodynamic changes.
时间窗: Intraoperative.
次要结局
- Onset time to reach peak sensory and motor block and assessment of adverse effect.(Postprocedural.)
研究者
Saikat Kundu
Institute of Post Graduate Medical Education And Research, Kolkata
研究点 (1)
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