Comparison of sevoflurane and desflurane for post-operative neurocognitive dysfunction in patients undergoing spine surgeries : A prospective randomized controlled close- ended assessor blinded clinical trial.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- SELF
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Incidence of POCD Assessed using a validated battery of neuropsychological tests administered preoperatively baseline (24 hrs prior) and postoperatively e.g postoperative day 7 and day 30. POCD is defined as a significant decline in cognitive test performance compared to baseline. The primary comparison is between the sevoflurane group and the desflurane group to evaluate the impact of the anesthetic agent on cognitive outcomes.
研究概览
简要总结
COMPARISON OF SEVOFLURANE AND DESFLURANE FOR POST-OPERATIVE NEUROCOGNITIVE DYSFUNCTION IN PATIENTS UNDERGOING SPINE SURGERIES : A PROSPECTIVE RANDOMIZED CONTROLLED CLOSE ENDED DOUBLE-BLINDED CLINICAL TRIAL
This study aims to compare the effects of sevoflurane and desflurane on post-operative cognitive dysfunction POCD in young adults undergoing spine surgery. POCD is a temporary cognitive decline following surgery, characterized by impairments in memory, attention, and executive function. It is believed to be caused by mechanisms such as neuroinflammation, oxidative stress, and neurotoxicity, which are often exacerbated by anesthetic agents. Desflurane and sevoflurane are modern anesthetics, with desflurane offering quicker recovery times but having a pungent odor, while sevoflurane provides smoother induction.
The study will assess POCD pre-operatively, 24 hours, and 6 months post-surgery using psychometric tests. Secondary objectives include monitoring changes in cognitive scores MoCA and regional cerebral oxygen saturation rSO2 during surgery, and comparing intraoperative hemodynamics. The literature review highlights that POCD can last from months to years, with near-infrared spectroscopy NIRS being used to monitor rSO2 and potentially reduce POCD risk.
Hypothesis
1. Desflurane (shorter acting) would be associated with less POCD when compared with sevoflurane
2. Similar rSO2 patterns in both groups
3. Positive correlation between decrease in rSO2 and POCD Incidence
The study is a randomized controlled trial with young and middle-aged adults 18-59 years undergoing elective lumbar or thoracic spine surgeries. The sample size is estimated at 140 participants, with inclusion criteria ensuring a relatively healthy population without pre-existing cognitive impairments. The hypothesis is that desflurane, due to its shorter acting profile, will result in less POCD compared to sevoflurane.
Ethical considerations include informed consent, confidentiality, and voluntary participation. The expected outcome is that desflurane may favorably impact cognitive function post-surgery due to quicker emergence, reduced exposure time, and improved hemodynamic stability. However, the influence of patient-specific factors and anesthesia management techniques will also play a role in the results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 59.00 Year(s)（—）
- 性别
- All
入选标准
- •Age-young and middle aged adults ASA 1 and 2 Surgery of lumbar or thoracic spine surgery Level of education_at least till high school Preop MMSE greater than or equal to 23 Absence of serious hearing or vision impairment.
排除标准
- •Known cases of dementia or any psychiatric illness History of CVA with residual deficit Alcoholism , drug dependence Current use of benzodiazepine, antidepressants or psychotropic drugs Contraindication to use of inhalational agents Emergency nature of surgery Perioperative complications- requirements of post op ventilation, hemodynamic instability.
结局指标
主要结局
Incidence of POCD Assessed using a validated battery of neuropsychological tests administered preoperatively baseline (24 hrs prior) and postoperatively e.g postoperative day 7 and day 30. POCD is defined as a significant decline in cognitive test performance compared to baseline. The primary comparison is between the sevoflurane group and the desflurane group to evaluate the impact of the anesthetic agent on cognitive outcomes.
时间窗: preoperatively (24 hrs), post-op day 7, post op day 30.
次要结局
- Change in MoCA Score(Difference in MoCA scores from baseline to postoperative will be calculated to assess cognitive decline & compare between groups)