Comparison of the Effect of Sugammadex and Neostigmine on Postoperative Cognitive Dysfunction in Elderly Patients Undergoing Elective Surgery Under General Anesthesia- A Prospective, Randomized, Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 76
- 试验地点
- 1
研究概览
简要总结
Postoperative cognitive dysfunction following surgery under general anesthesia is a known complication particularly among elderly patients.This study compares the effectiveness of sugammadex to neostigmine in reduction of post operative cognitive dysfunction in elderly patients undergoing elective surgery under general anesthesia. 76 patients meeting inclusion criteria will be assessed one day before surgery using MoCA, MMSE, QoR15 score.On the day of surgery, patients will be randomized into two groups, the first group receiving inj. sugammadex and the other receiving ins neostigmine and glycopyrrolate as reversal for neuromuscular blockade. The primary outcome is to compare cognitive function using MoCA score on POD 1 in both the groups. Secondary outcomes include TOF recovery time, extubation time, incidence of PONV, Quality of recovery.
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
- 60.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •American Society of Anesthesiologists (ASA) status I-III patients undergoing elective surgery under general anesthesia.
排除标准
- •1.Known case of dementia or preoperative (Baseline) MMSE score less than 22 2.Severe audio-visual impairments and patients unable to read or write.
- •3.Allergy to any of the drugs used in the study including sugammadex.
- •4.Congestive heart failure, liver and renal failure 5.History of stroke, cerebral surgeries, active infection, electrolyte imbalance 6.History of known psychiatric/ neurodegenerative disorder 7.Chronic opioid or substance abuse, patients on sedatives, antidepressants, and glucocorticoids 8.Patients with neuromuscular disorders 9.Patients undergoing cardiac, vascular, and neuro-surgeries.
研究者
Dr Arjun Prasad Chaudhary
Jawaharlal Institute of Postgraduate Medical Education and Research