Preoperative Nebulized Dexmedetomidine Versus Nebulized Magnesium Sulphate in Reducing Emergence Agitation in Adult Undergoing Functional Endoscopic Sinus Surgery.
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The primary endpoint will Visual Analogue Scale (VAS)score after anesthesia
研究概览
简要总结
Emergence agitation after sinus surgery is a common postoperative complication characterized by confusion, disorientation, and potentially violent behavior as a patient wakes from general anesthesia.This study compare the effect of nebulized dexmedetomidine versus nebulized magnesium sulphate in reducing emergence agitation in adult undergoing functional endoscopic sinus surgery.
This study aims to compare preoperative nebulized dexmedetomidine and nebulized magnesium sulphate in reducing emergence agitation in adult undergoing functional endoscopic sinus surgery.
详细描述
Type of Study: Prospective, randomized, double-blind, comparative clinical study.
Study Setting: Ain Shams University hospitals, Cairo, Egypt. Study Period: 6-12 months. Study Population: Adult patients scheduled for elective functional endoscopic sinus surgery.
Sampling Method: Random sampling Sample Size Based on the results of Ahmed et al 2022, with the mean VAS in patients treated with magnesium sulphate 7.2 ± 1.9 while the mean in Dexmedetomedine group 2.7 ± 0.9 Alpha error 5%,power of study 80% the required sample size is 50 patients, 25 patients in each group. The program for sample size calculation is STATA 10.
Ethical Considerations:
The study protocol will receive ethical approval from the Research Ethical Committee, Faculty of Medicine Ain Shams University. Informed consent will be obtained from all participants before starting study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients between 21 and 50 years of age undergoing elective functional endoscopic sinus surgery.
- •American Society of Anesthesiologists physical status classification (ASA) I and II.
排除标准
- •Patient's refusal.
- •Complicated sinus surgery.
- •History of allergy to any of the study drugs.
- •Baseline HR≤60 beat/min.
- •Baseline mean arterial pressure (MAP)≤70 mmHg.
- •Psychiatric illness.
- •Cerebrovascular insufficiency.
研究组 & 干预措施
Group D (Dexmedetomedine)
Patients in Group D will be nebulized with 1 μg/kg nebulized dexmedetomidine completed to 3 ml using normal saline 30 min before operation
干预措施: Dexmedetomidine (Drug)
Group M ( Magnesium Sulphate)
Group M will be nebulized with 250 mg nebulized magnesium sulfate completed to 3 ml using normal saline
干预措施: Magnesium sulfate (Drug)
结局指标
主要结局
The primary endpoint will Visual Analogue Scale (VAS)score after anesthesia
时间窗: 30 minutes after operation in PACU
Pain will be assessed by VAS Score where 0 is no pain and 10 is the worst pain possible
次要结局
- The recovery time and Aono's four-point score will assessed as secondary endpoints. The number, severity, and duration of agitation episode.(30 minutes after operation in PACU)
- The recovery time(30 minutes after operation in PACU)
- Aono's four-point score will assessed as secondary endpoints.(30 minutes after operation in PACU)
- The number, severity, and duration of agitation episode.(30 minutes after operation in PACU)