Utilization of NIRS Monitor to compare regional cerebral oxygen saturation between opioid and opioid sparing anesthesia and post operative cognitive dysfunction in elderly patients undergoing laparoscopic surgery a double blinded randomized controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To determine the association between opioids and frontal lobe hypoperfusion indicated by using NIRS.
研究概览
简要总结
ostoperative cognitive decline (POCD) is common after surgery, especially in elderly patients. Opioid-based anesthesia, though effective for analgesia, is linked to cognitive impairment, respiratory depression, and other complications. Opioid-free anesthesia (OFA) using agents like dexmedetomidine, ketamine, and lidocaine may reduce these risks while preserving cognitive function. Cerebral oximetry via near-infrared spectroscopy (NIRS) helps monitor brain oxygenation, which influences cognitive outcomes. This study compares POCD incidence in elderly patients undergoing laparoscopic gastrointestinal surgery with opioid-based versus opioid-free anesthesia, correlating cognitive outcomes with intraoperative cerebral oxygenation levels to determine the potential benefits of OFA in reducing cognitive impairment.
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 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Age above 60 years.
- •Either sex
- •Undergoing laparoscopic cholecystectomy over 60 minutes
- •Can give informed consent themselves
- •Minimum cognitive performance required to participate is ACE-III score more than 88.
排除标准
- •EXCLUSION CRITERIA:
- •Patients with a history suggestive of dementia (either listed in the medical record or reported by the patient) or any neurological disorder.
- •History of alcohol abuse, chronic opioid or other substance abuse
- •History of cerebral surgeries, stroke.
- •History suggestive of psychiatric disease like schizophrenia, dementia, anxiety or other disorder affecting cognition, mental dysfunction
- •Prescription of central nervous system–active medications (eg: antidepressants, antipsychotics, sedatives).
结局指标
主要结局
To determine the association between opioids and frontal lobe hypoperfusion indicated by using NIRS.
时间窗: Baseline, every 10 minutes intraoperatively
次要结局
- To compare the incidence of post operative delirium(3. To determine the association between cerebral perfusion & incidence of postoperative cognitive dysfunction & delirium)
研究者
Puneet Khanna
All India INSTITUTE of Medical Sciences New Delhi