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临床试验/CTRI/2025/02/080277
CTRI/2025/02/080277尚未招募不适用

A comparative study of intravenous injection ondansetron and injection granisetron on spinal anaesthesia induce hypotension and bradycardia.

BJMedical college AhmedabadGovernment of Gujurat1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2025年2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
104
试验地点
1
主要终点
This study is aimed to compare prevention of spinal anaesthesia induced hypotension and bradycardia in both drug groups.

研究概览

简要总结

Spinal anaesthesia is most popular mode of anaesthesia for both elective and emergency

procedures in abdomen and lower limb surgeries. The most common hemodynamic

adverse following spinal anaesthesia are hypotension and bradycardia.Hypotension

results primarily from decreased systemic vascular resistance and central venous pressure

from sympathetic block, whereas bradycardia is secondary to a relative parasympathetic

dominance, increased baroreceptor activity or a result of the Bazold-Jarisch-Reflex

(BJR). This reflex is elicited by stimulation of peripheral serotonin receptors 5-

Hydroxytryptamine (5-HT3 type) which are both mechanosensitive and

chemosensitive.Stimulation of cardiac chemoreceptors in the heart by decreased

venous return increases the parasympathetic activity and decreases the sympathetic

activity resulting in vasodilatation and bradycardia. This study concentrated on two 5HT3

receptor antagonists, which can minimise the occurrence of hypotension and bradycardia

after spinal anaesthesia. They are Ondansetron and Granisetron which are selective 5-

HT3 receptor antagonists.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • American Society of Anaesthesiologist (ASA) Classification grade I, II.
  • Patient willing to consent for surgery.
  • Weight of patient (40-60 kg).

排除标准

  • Patient refusal.
  • History of allergy to local anaesthetic drugs and study drug.
  • Contraindications to spinal anaesthesia.
  • Patients with history of bleeding disorders or on anticoagulant therapy.
  • American Society of Anaesthesiologist (ASA) Classification III, IV and V.
  • Emergency surgeries.

结局指标

主要结局

This study is aimed to compare prevention of spinal anaesthesia induced hypotension and bradycardia in both drug groups.

时间窗: This study is aimed to compare incidence of hypotension and bradycardia in both drug groups intra operative and postoperative for upto 12 hours

次要结局

  • Total dose of atropine & mephentermine required intra operatively.(Any time of hypotension or bradycardia during intra op requirements of atropine & mephentermine.)

研究者

发起方
BJMedical college AhmedabadGovernment of Gujurat
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Patel Vidhi Mukeshbhai

B.J. Medical College and Civil Hospital , Ahmedabad

研究点 (1)

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