Premedication With Atenolol Versus Metoprolol for Controlled Hypotensive Anesthesia During Nasal Surgeries. A Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Mean and Standard deviation of Blood loss (ml)(mean±SD)
研究概览
简要总结
Objectives: To compare the safety and efficacy of oral atenolol versus oral metoprolol as a premedication for controlled hypotensive anesthesia during nasal surgeries.
Background: Mucosal bleeding is the most frequent complication with nasal surgeries, as it interferes with the optimal visualization of the intranasal anatomy, increases operation time, and consequently increases blood loss. There are several pharmacological and non-pharmacological techniques for the appropriate control of intraoperative bleeding.
Patients and Methods: This was a prospective, randomized, double-blind, phase four, comparative clinical trial; carried out on 60 patients, who were candidates for nasal surgeries under general anesthesia at our hospital. Patients were randomly allocated into two equal groups; group A, received oral atenolol, and group M, received oral metoprolol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) physical status ≤ II
- •Age from 21 to 50 years
排除标准
- •ASA physical status > II
- •Age < 21 years or > 50 years
- •Pregnant women
- •Breastfeeding
- •Bronchial asthma
- •Chronic obstructive pulmonary disease
- •Diabetes Mellitus
- •Hypertension
- •Ischemic heart disease
- •Rheumatic heart disease
- •Heart failure
- •Heart block
- •Sick sinus syndrome
- •Sinus bradycardia
- •Chronic hypotension
- •Anemia (Hb < 10 g/dl)
- •Renal or hepatic dysfunction
- •Central nervous system disease
- •Allergic fungal sinusitis
- •Patients on beta-blockers
- •Alcohol or drug abuse
- •Anticoagulation therapy,
- •Bleeding diathesis
- •Agents influencing autonomic nervous system
- •Allergy to the study drugs
- •Any contraindication of oral intake
研究组 & 干预措施
Group A (n=30)
Atenolol group
干预措施: Atenolol Succinate Oral Tablet (Drug)
Group M (n=30)
Metoprolol group
干预措施: Metoprolol Succinate Oral Tablet (Drug)
结局指标
主要结局
Mean and Standard deviation of Blood loss (ml)(mean±SD)
时间窗: 5 minutes after the end of surgery
Amount of blood loss at the end of surgery
次要结局
未报告次要终点