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临床试验/CTRI/2025/02/081063
CTRI/2025/02/081063尚未招募2/3 期

Role of Dexmedetomidine in reduction of arrhythmias post long cardiopulmonary bypass exposure

Dr Kamna Nagar1 个研究点 分布在 1 个国家目标入组 176 人开始时间: 2025年3月3日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
176
试验地点
1
主要终点
Reduction in the incidence of arrhythmias post long cardiopulmonary bypass exposure.

研究概览

简要总结

This study is a placebo-controlled, case-control trial conducted at King George’s Medical University, Lucknow, to evaluate the role of dexmedetomidine in reducing arrhythmias post long cardiopulmonary bypass (CPB) exposure.

Study Design:

  • **Type:** Case-control study

  • **Setting:** Department of Anaesthesiology & CTVS, KGMU

  • **Duration:** One year

  • **Sample Size:** 176 patients (88 per group)

  • **Groups:**

  • **Group A (Intervention):** Dexmedetomidine (1 µg/kg over 10 minutes during CPB rewarming)

  • **Group B (Control):** Placebo (normal saline)

Objectives:

  • **Primary Outcome: Reduction in the incidence of arrhythmias post-CPB (e.g., premature ventricular contractions, atrial fibrillation, ventricular tachycardia).

  • **Secondary Outcomes:

  • Fast-tracking recovery(earlier extubation, shorter ICU stay)

  • Reduced need for anti-arrhythmic drugs(e.g., amiodarone)

Time Points for Outcome Assessment:

  • Primary Outcome:**

  • Pre-induction (baseline), intraoperative (during CPB rewarming), and postoperative (ICU stay).

  • Secondary Outcomes:

  • **Fast-tracking recovery: Time to extubation and ICU discharge.

  • **Need for anti-arrhythmic drugs: Postoperative ICU period until hospital discharge.

Methodology:

  • Patients undergoing elective valve replacement or congenital cardiac surgery will be enrolled.

  • Randomization and allocation concealment methods are not explicitly mentioned but likely involve computer-generated sequences and sealed envelopes.

  • Statistical analysis will be done using SPSS and MS Excel, with a **p-value < 0.05** considered significant.

This study aims to determine whether dexmedetomidine administration during CPB rewarming can effectively reduce perioperative arrhythmias, improve hemodynamic stability and facilitate faster postoperative recovery.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

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

入选标准

  • Patients scheduled for elective valve replacement surgery
  • Adult patients scheduled for congenital cardiac surgery
  • Patients providing written informed consent.

排除标准

  • 未提供

结局指标

主要结局

Reduction in the incidence of arrhythmias post long cardiopulmonary bypass exposure.

时间窗: 36 weeks

This includes monitoring ECG changes, heart rate, and the occurrence of arrhythmias (such as premature ventricular contractions, atrial fibrillation, and ventricular tachycardia) before induction, during surgery, and in the postoperative ICU period.

时间窗: 36 weeks

次要结局

  • 1. Advantage in fast-tracking recovery , Evaluating whether dexmedetomidine facilitates earlier extubation & ICU discharge.(2. Reduction in the use of long acting anti-arrhythmic drug infusions – Specifically assessing the decreased need for amiodarone or other anti-arrhythmic medications postoperatively.)

研究者

发起方
Dr Kamna Nagar
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Kamna Nagar

King Georges Medical University Lucknow

研究点 (1)

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