Efficacy of Sublingual Caffeine on Reducing Recovery Time and Postoperative Agitation in Elderly Patients Undergoing General Anesthesia: A Double-Blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Time to emergence
研究概览
简要总结
This study aims to evaluate the efficacy of sublingual caffeine in reducing recovery time and incidence of postoperative agitation in elderly patients undergoing general anesthesia.
详细描述
With increasing life expectancy, the proportion of elderly patients undergoing surgical procedures under general anesthesia continues to rise. However, aging is associated with reduced physiological reserve and altered pharmacokinetics and pharmacodynamics of anesthetic agents, making elderly individuals particularly susceptible to delayed emergence from anesthesia.
Caffeine, a methyl xanthine compound widely known for its central nervous system (CNS) stimulant properties, has shown potential to accelerate emergence from general anesthesia. It acts as a non-selective antagonist of adenosine A1 and A2A receptors, which play a role in promoting sleep and suppressing arousal.
Postoperative agitation and delirium are particularly concerning in older adults due to their association with increased morbidity, functional decline, prolonged hospitalization, and even long-term cognitive impairment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 65 years.
- •Both sexes.
- •American Society of Anesthesiologists (ASA) physical status II.
- •Scheduled for elective ophthalmology surgery under general anesthesia.
排除标准
- •History of severe cardiac arrhythmias or uncontrolled hypertension.
- •ASA III patients were excluded to reduce the risk of adverse events in elderly patients with severe systemic diseases.
- •Known allergy or hypersensitivity to caffeine.
- •Pre-existing cognitive impairment or dementia (All patients will undergo preoperative cognitive screening using the online Mini-Cog test or Montreal Cognitive Assessment [MoCA]).
- •History of seizures or epilepsy.
- •History of alcohol or drug abuse.
- •Chronic use of CNS stimulants or sedatives.
- •Emergency surgeries.
- •Prolonged procedures for more than 3 hours.
研究组 & 干预措施
Caffeine group
Patients will receive sublingual caffeine at the end of surgery.
干预措施: Caffine citrate (Drug)
Placebo group
Patients will receive sublingual placebo at the end of surgery.
干预措施: Placebo (Other)
结局指标
主要结局
Time to emergence
时间窗: Till the patient opens eyes in response to a verbal command (Up to 15 minutes)
Time to emergence, defined as the time interval (in minutes) from discontinuation of inhalational anesthetic agents to the moment the patient opens eyes in response to a verbal command. Measurement will be done using a stopwatch starting at anesthetic discontinuation.
次要结局
- Time to discharge from post-anesthesia care unit(Till leaving the post-anesthesia care unit (Up to 120 minutes))
- Postoperative agitation(30 minutes of post-extubation)
- Incidence of complications(24 hours postoperatively)
研究者
Ghada AboBakr Mohamed Sherif
Lecturer of Anesthesiology, Surgical Intensive Care and Pain Management, Faculty of Medicine - Cairo University
Cairo University