Comparison of Verapamil With Adenosine After Vagal Maneuvers in Patients Presenting With Paroxysmal Supraventricular Tachycardia (pSVT), in a Tertiary Care Hospital of Lahore, Pakistan
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- achieve the normal sinus rhythm
研究概览
简要总结
Supraventricular tachycardia (SVT) is a term widely used to describe tachycardial dysrhythmias, paroxysmal SVT (PSVT) is a narrow term including only AV nodal re-entrant tachycardia (AVNRT) and atrioventricular re-entrant tachycardia (AVRT), both of which can cause discomfort and, in some cases, life-threatening symptoms.
Usually Carotid sinus massage is done to lower the pulse rate and after the standard time specific verapamil dose is administered. In this study after carotid sinus massage Conventional Valsalva or modified Valsalva maneuver will be randomly applied. In case, the normal sinus rhythm (NSR) is not achieved then verapamil of or adenosine dose will be administered to the patients after after taking the consent.
详细描述
Supraventricular tachycardia (SVT) is a term widely used to describe tachycardial dysrhythmias, paroxysmal SVT (PSVT) is a narrow term including only AV nodal re-entrant tachycardia (AVNRT) and atrioventricular re-entrant tachycardia (AVRT), both of which can cause discomfort and, in some cases, life-threatening symptoms. The incidence of PSVT is approximately 1 in 300 and this prevalence increases with age.
Maneuvers that increase vagus activity have been used to terminate PSVT. Vagal maneuvers reduce the rate of stimulation of the sinus node, slow the rate of delivery to the atrioventricular node, and prolong the refractory period. Vagal-maneuver techniques include carotid sinus massage, the diving reflex, the oculocardiac reflex, and Valsalva maneuvers. Because vagal maneuvers are a non-invasive technique, recent guidelines recommend them as a first-line treatment before medical intervention to terminate PSVT.
Since the 17th century, the Valsalva maneuver (VM) has been used in daily practice and aims to challenge the individual with forced expiration while the glottis is closed, or exhalation to raise the mercury column in tubing of standard manometer to 40 mmHg. In clinical practice, VM has varied success rates (5-20%) in terminating PSVT. It has been found that the patient's posture is an important factor affecting the success of VM. In addition, several studies and case reports have shown that VM with simple, safe modifications (modified VM) is more effective in terminating PSVT. These modifications include pressing the epigastric zone or abdomen for 10 seconds after VM; changing position quickly, such as from being seated to supine; or lifting the feet at a 45-degree angle just after the VM.
Efficacy of SVM in restoring sinus rhythm is less than 25% while of Modified Valsalva maneuver (MVM)) has showed higher efficacy (> 40%).6 However, few studies have evaluated the success rate of modified VM. Therefore, the present randomized controlled study aimed to detect whether modified VM is more effective than standard VM in terminating PSVT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Modified Valsalva with adenosine will be administered on Monday and Tuesday Conventional Valsalva with adenosine will be administered on Wednesday and Thursday Modified Valsalva with verapamil will be administered on Friday and Saturday
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stable SVT (not requiring cardioversion, fully conscious, maintaining systolic blood pressure of >90mmHg)
- •Alert enough and able to give consent
- •Able to lie flat and non-painful legs during passive leg raising
排除标准
- •Unstable SVT (Semiconscious, drowsy, breathless, systolic BP <90mmHg)
- •Not able to give consent
- •Orthopnea causing inability to lie flat
- •Atrial fibrillation/atrial flutter
- •Recent MI (within last 7 days)
- •Ongoing ischemia as indicated by chest pain or ST segment depression/elevation in ECG
- •Aortic stenosis
- •All trimesters of pregnancy
研究组 & 干预措施
Group A: Conventional Valsalva
Performance of forced expiration in the standard manometer tubing to generate a pressure of 40 mmHg for 15 seconds while lying on back or sitting position.
干预措施: Adenosine (Drug)
Group B: Modified Valsalva Maneuver
Patient will be placed in semi-recumbent position and instructed to exhale forcefully in manometer to generate pressure of 40 mmHg for 15 seconds, immediately followed by supine repositioning of the bed, and simultaneous passive leg raising to 45 degree with the help of one assistant standing on the foot side, for 15 seconds.
干预措施: Adenosine (Drug)
Group C: Modified Valsalva Maneuver
Patient will be placed in semi-recumbent position and instructed to exhale forcefully in manometer to generate pressure of 40 mmHg for 15 seconds, immediately followed by supine repositioning of the bed, and simultaneous passive leg raising to 45 degree with the help of one assistant standing on the foot side, for 15 seconds.
干预措施: Verapamil Injection (Drug)
结局指标
主要结局
achieve the normal sinus rhythm
时间窗: 24 to 36 hours
As the patient came to ER blood pressure and primary information will be collected by the in-charge nurse. then treatment will be provided in following steps First; carotid message will be done. Supraventricular tachycardia (SVT) reverted to normal sinus rhythm (NSR), And if NSR not achieved, Vagal maneuver as mentioned in methodology will be performed, And if NSR not achieved, Randomly, IV verapamil or adenosine will be injected. After achieving NSR the patient will be kept under observation for 30 min after that the patient will be asked to visit the Outpatient department (OPD) in the next working day.
次要结局
- Efficacy of standard or modified vagal maneuver(10 minutes)
- Efficacy of IV verapamil and IV adenosine(30 to 60 minutes)
研究者
Arslan Saleem
Biostatistician
Rashid Latif Medical College