Is Labetalol More Effective Than Metoprolol for Controlled Hypotensive Anesthesia During Endoscopic Nasal Surgeries? A Randomized Clinical Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 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
Background: Mucosal bleeding is the most frequent complication with endoscopic nasal surgeries, as it interferes with the optimal visualization of the intranasal anatomy, leading to increased complications, operation duration, and blood loss. There are several pharmacological techniques for the appropriate control of intraoperative bleeding.
Objectives: To compare the safety and efficacy of oral labetalol versus oral metoprolol as a premedication for controlled hypotensive anesthesia during endoscopic nasal surgeries.
Patients and Methods: This is a randomized, double-blind, phase four, comparative clinical trial; carried out on 60 patients, who were candidates for endoscopic nasal surgeries under general anesthesia at our hospital. Patients were randomly allocated into two equal groups; group L, received oral labetalol, 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
- •Body Mass Index (BMI) ≤ 35 kg/m2
排除标准
- •ASA physical status > II
- •Age < 21 years or > 50 years
- •Pregnant women
- •Breastfeeding
- •Bronchial asthma
- •Chronic obstructive pulmonary disease
- •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
- •Bleeding diathesis
- •Diabetes Mellitus
- •Allergic fungal sinusitis
- •Patients on beta-blockers, tricyclic antidepressants, alcohol or drug abuse, anticoagulation therapy, agents influencing the autonomic nervous system
- •Patients using pacemakers
- •Allergy to the study drugs
- •Any contraindication of oral intake
研究组 & 干预措施
Group L (n=30)
Labetalol group
干预措施: Labetalol Hydrochloride Oral Tablet (Drug)
Group M (n=30)
Metoprolol group
干预措施: Metoprolol Tartrate Oral Tablet (Drug)
结局指标
主要结局
Mean and Standard deviation of Blood loss (ml)(mean±SD)
时间窗: 30 minutes after the end of surgery
Amount of blood loss at the end of surgery
次要结局
- Mean and Standard deviation of Sevoflurane concentration (%)(mean±SD)(30 minutes after the end of surgery)
- Mean and Standard deviation of Heart rate (beat/min.)(mean±SD)(30 minutes after the end of surgery)
- Mean and Standard deviation of Mean Blood Pressure (mmHg)(mean±SD)(30 minutes after the end of surgery)
- Number of participants and Percentage of Drug-related side effects(30 minutes after the end of surgery)