Efficacy of Two Different Doses of Labetalol Hydrochloride for Attenuation of Haemodynamic Response to Laryngoscopy and Endotracheal Intubation in Controlled Hypertensive Patients – Prospective Randomized Double Blind Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- SSG Hospital
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Both doses of Labetalol Hydrochloride are expected to attenuate hemodynamic response to laryngoscopy and intubation in dose dependent manner in controlled hypertensive patients.
研究概览
简要总结
InIndia, the prevalence of hypertension is 28%–32% in the urban population and27.6% in the rural population.Thus, anaesthesiologists are likely to encountermore patients with this comorbid illnesses presenting for elective surgery. These patients have high incidenceof cardiac arrhythmias, myocardial ischemia, acute left ventricular failure andcerebrovascular accidents following intubation. Hypertensive patients exhibitexaggerated intubation response. Hence, suppression of intubation response isalways desirable.Hypertensive surges more >20% from baseline are associated with adverseoutcomes and should be urgently treated with the goal of blood pressurereduction.
After going into details of different studies and considering the pro andcons of different doses, we have decided to compare 0.15 mg/kg and 0.30 mg/kgfor attenuation of stress response to laryngoscopy and intubation in our study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •We include ASA grade II patients posted for planned surgery under general anasthesia requiring orotracheal intubation and having controlled hypertension.
排除标准
- •Patients who refuse to give consent.
- •Pregnant and lactating women.
- •Anticipated difficult airway and obesity(BMI >35).
- •Patient having allergy to study drug.
- •Patient with sick sinus syndrome (including sino-atrial block),second or third degree heart block and persistent bradycardia (<45-50 bpm).
- •Patients is having history of taking medication for any sort of illness like verapamil, diltiazem, digitalis glycosides, clonidine, monoamineoxidase inhibitors (except MOA-B inhibitors) and beta blocker.
- •Patient with systemic diseases like cardiovascular, respiratory diseases like bronchial asthma and COPD, neurological, psychological, hepatic, untreated phaeochromocytoma,renal disease (diagnosed by clinical judgments and investigations) and on medication of above mentioned diseases.
- •Time more than 20s or requiring more than two attempts for laryngoscopy and intubation.
结局指标
主要结局
Both doses of Labetalol Hydrochloride are expected to attenuate hemodynamic response to laryngoscopy and intubation in dose dependent manner in controlled hypertensive patients.
时间窗: Both doses of Labetalol Hydrochloride attenuate hemodynamic response to laryngoscopy and intubation in dose dependent manner in early 20 minutes after doing airway instrumentation in controlled hypertensive patients.as this first this few minutes is very crucial causing complication like myocardial ischemia and cerebrovascular events we will observe the response for this early minutes after airway instrumentation.
次要结局
- To study the different side effect of study drug(we will obeserve various complication like bradycardia,hypotension,any cardiac arrythmia in the patient till after the giving study drug to the complition of operative procedure.)