The Effect of N-acetylcysteine in reducing post operative cognitive dysfunction after anaesthesia in elderly patients undergoing day-care surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 296
- 试验地点
- 1
- 主要终点
- To evaluate the effect of N-Acetylcysteine (NAC) on Postoperative cognitive dysfunction (POCD) in elderly patients undergoing day-care surgery.
研究概览
简要总结
| Participants in this study will be divided into |
| two groups: |
-Group 1: If you are in this group, you will receive 400-600 mg of NAC orally before your surgery.
After the surgery, you will continue to take 400-600 mg of NAC orally twice daily for two days.
-Group 2: If you are in this group, you will receive a placebo treatment, which serves as abenchmark for comparison.
We will assess your cognitive function using the Mini Mental State Examination (MMSE) at various time points: 2 hours before surgery (as a baseline score), 1 hour after surgery, 6 hours after surgery, 12 hours after surgery, and 24 hours after surgery. This helps us understand how your cognitive function may change over time.
In addition to cognitive assessments, we will carefully evaluate your recovery using the Modified
Aldrete Score (MAS) to determine your readiness for discharge from the post-anesthesia care unit (PACU). The MAS considers key recovery indicators such as activity, respiration, circulation, consciousness, and oxygen saturation. A score of 9 or higher usually indicates that you are ready to be discharged.
We will also take into account your overall Quality of Recovery (QOR), which includes aspects such as physical comfort, emotional well-being, and overall satisfaction with your recovery process. This comprehensive assessment ensures that your recovery is thoroughly evaluated not only in terms of physical health but also in terms of your overall experience.
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
- 55.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged 55 years and older.
- •Scheduled for elective daycare surgery under general and spinal anaesthesia.
- •Capable of providing informed consent.
- •Patients with an American Society of Anaesthesiologists (ASA) physical status classification I-III, indicating they are generally healthy or have mild to moderate systemic disease.
- •Patients weighing between 40 kg and 80 kg, to ensure the appropriateness of the NAC dosing regimen.
- •Patients undergoing non-cardiac and non-neuro-related surgery.
- •Either gender of patients can be included.
排除标准
- •Known allergy or contraindication to NAC.
- •Severe systemic diseases or unstable medical conditions.
- •Pre-existing cognitive impairment or neurodegenerative diseases.
- •Concurrent participation in another clinical trial.
- •Cardiac and neurosurgery patients.
- •Undergoing surgery for trauma.
- •Lack of the capacity to consent to their surgery.
- •Are unable to comply with the requirements of informed consent or the study protocol.
- •Subject who participated in any other clinical investigation using an experimental drug in the past 3 months.
- •Participants who are not willing to sign the ICF and to attend treatment schedule regularly.
- •Pre-existing psychiatric illness such as Alzheimer’s disease, or dementia.
- •History or current use of opioid abuse.
- •Ortho Surgeries involving upper limbs.
结局指标
主要结局
To evaluate the effect of N-Acetylcysteine (NAC) on Postoperative cognitive dysfunction (POCD) in elderly patients undergoing day-care surgery.
时间窗: POCD is surveyed with the Mini Mental State Examination (MMSE) at initially 2 hours before surgery as a baseline score, followed by 1 hour after surgery, 6 hours after surgery, 12 hours after surgery, and 24 hours after surgery.
次要结局
- •To assess the Quality of recovery of Postoperative cognitive dysfunction (POCD) patients undergoing day-care surgery.(•To assess readiness to discharge after N-acetylcysteine administration.)
研究者
DR MG Rajanandh
SRM Institute of Science and Technology