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临床试验/CTRI/2023/11/059631
CTRI/2023/11/059631尚未招募不适用

Effect of hyperbaric ropivacaine with and without dexmedetomidine as an adjuvant in spinal anaesthesia for caesarean section:A prospective observational study

Mohammadfaizan kanuga1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年11月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
1)Onset and duration of sensory &motor blockade

研究概览

简要总结

Spinal anaesthesia is technique of choice for anaesthesia in patients undergoing caesarean section due to its rapid onset, surety of effect, decreased blood loss and good safety profile. With the advantage of avoiding maternal risk of general anaesthesia including failure of tracheal intubation, aspiration pneumonitis and lung infection.

Ropivacaine, a long acting amino-amide local anaesthetic agent is similar to bupivacaine in chemical structure. Previous studies for isobaric ropivacaine for neuraxial blockage have been shown to be safe and effective [1]. Hyperbaric local anaesthetics produce predictable block characteristics and effective spinal anaesthesia.

Dexmedetomidine, a highly selective alpha-2 adrenergic agonist provides sedative, analgesic, anti-sympathetic effects and has no significant effect on respiration. The results of previous study indicate that 5 microgram dexmedetomidine as an intrathecal adjuvant to 0.5% hyperbaric bupivacaine for caesarean section is useful as it hastens the onset of sensory and motor block and prolongs postoperative analgesia and motor blockage without producing significant hemodynamic changes, sedation and neonatal adverse effects [2].

As this technique and drugs being used routinely in our institute, we are just doing observation of what is happening. We are not doing any intervention in standard protocol of our institute. So this is a observational study.

So, we aim to study the recently available hyperbaric ropivacaine and compare it with combination of hyperbaric ropivacaine and dexmedetomidine 5 microgram given intrathecally for lower segment caesarean section.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • Patients posted for elective or emergency caesarean section receiving spinal anaesthesia 2) Patients in the age group of 18-40 years 3)Patients having height of 145-165cm 4) Patients belonging to ASA grade I, II or III 5) Patients giving written informed consent.

排除标准

  • Contraindication to spinal anaesthesia (Patient Refusal, Coagulopathy, localized infection and neurological diseases, allergy to study drugs) 2)Patient having major cardio-respiratory disorders or major hepato-renal disorders 3)Multifetal pregnancies 4)Suspected fetal abnormalities 5)Fetal compromised 6)Severe PIH.

结局指标

主要结局

1)Onset and duration of sensory &motor blockade

时间窗: 24 hours

2)Duration of post operative analgesia and 24 hours analgesic requirement

时间窗: 24 hours

次要结局

  • 1)Hemodynamic parameters(2)Adverse effects and side effects)

研究者

发起方
Mohammadfaizan kanuga
申办方类型
Other [self]

研究点 (1)

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