Effect of family members recorded voice during recovery from general anaesthesia on emergence delirium in elderly patients A randomised controlled trial
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- To compare incidence of postoperative emergence delirium in PACU in elderly patients
概览
简要总结
Delirium in the immediate postoperative period is a commonly encountered complication amongst patients in the PACU posing many immediate challenges and affecting long term outcomes. The incidence of Emergence Delirium (ED) varies greatly based on patient status as well as type of surgery but evidently higher in elderly population as compared to young adults. There is no universally accepted delirium risk prediction tool and opinions on drug-based prophylaxis of ED remain conflicting and there isn’t any conclusive evidence. However, most of the evidence published till date supports the use of non-pharmacological methods to prevent delirium. Amongst others, auditory stimuli are an easy and effective tool and have shown promising results. A clinical trial conducted in the paediatric population has shown that listening to mother’s recorded voice during emergence can reduce ED in children compared with hearing the recorded voice of a stranger. So we have planned an RCT to study the effectiveness of repeated auditory stimulus in the form of a family member’s recorded voice listened to during recovery compared with a stranger’s voice on the incidence of ED after general anaesthesia, especially in the elderly population keeping in mind the higher incidence in this age group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 65.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •Elderly patients more than 65 years belonging to ASA grade 1 or 2 scheduled for elective minimally invasive surgery, under general anaesthesia will be enrolled.
- •Written informed consent will be taken from every patient during pre-operative visits before surgery.
排除标准
- •1.Patients diagnosed with neuropsychiatric disorders, that is, schizophrenia, epilepsy, parkinsons disease, cognitive dysfunction, dementia 2.Patients with language barrier which hinders effective communication and assessment 3.Patients with hearing impairment or deafness 4.Absence of family member 5.History of neurosurgical procedure.
结局指标
主要结局
To compare incidence of postoperative emergence delirium in PACU in elderly patients
时间窗: 10 minutes (T1), 30 minutes (T2), and at discharge from the PACU (T3)
次要结局
- To compare incidence of postoperative delirium at postoperative Day 1(Postoperative Day 1 (POD1))
- To compare NRS pain scores in the PACU and postoperative Day 1(PACU and Postoperative day 1 (POD1))
- To compare extubation time (duration from cessation of anaesthetic to extubation)(NA)
- To compare eye opening time (time taken by patient to open his/her eyes from the time of cessation of anaesthetic agent)(NA)
- To compare duration of PACU stay(NA)
研究者
Dr Rucha Akash Bandegiri
All India Institute of Medical Sciences, Jodhpur