Correlation of Hippocampal volume and recovery after propofol sedation in patients undergoing Magnetic Resonance Imaging
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Assessment of recovery is made without any stimulation (tactile or noxious). Time to spontaneous eye opening and limb movement by the patients will be recorded from the time of stoppage of infusion.
研究概览
简要总结
General anaesthesia is a drug-induced, reversible condition that includes specific behavioral and physiological components of unconsciousness, analgesia, and akinesia with concomitant stability of the autonomic, cardiovascular, respiratory, and thermoregulatory systems.
Administration of a small dose of a hypnotic drug such like propofol, which acts on
γ-aminobutyric acid type A (GABAA) receptors, induces a state of sedation in which the patient is calm and easily arousable, with the eyes closed.
Arousal and maintenance of organized behavior during wakefulness is regulated by the central thalamus area of the ascending pathways from the brainstem and basal forebrain and descending pathways from the cortex. Studies have shown that the hippocampus too is a pivotal associated structure in the arousal pathway, and events that are seen post-operatively like delayed emergence, amnesia, post-operative delirium and post-operative cognitive decline can be attributed to the volume changes seen in hippocampus. Delayed recovery /emergence from anaesthesia is the abnormally slow pace of regaining consciousness after general anaesthesia which is characterised by persistent somnolence. Delayed recovery remains one of the biggest challenges that anaesthesiologists are concerned with, as it requires additional time to analyse and use of extra resources. The delay in recovery of the patients from sedation leads to increased duration of stay in the post-procedure room, increases the need for additional monitoring and care and duration of hospital stay.
Hippocampal electrical activity is shown to have direct correlation with sleep, wakefulness and arousal after anaesthesia. Several molecular and electrophysiological studies have shown that various factors ( sevoflurane/etomidate anaesthesia, temporal lobe resection leading to hippocampal atrophy in epilepsy patients ) affecting hippocampal cells or electrical activity causes delay in recovery from anaesthesia. Having established that, a recent study suggests that hippocampal volume correlates with the type of emergence from anaesthesia. As we are conducting a study which is exploratory in nature, based on the findings of the above mentioned studies studies, we hypothesised that delayed recovery after propofol sedation may be seen in patients with decreased hippocampal volumes.
The aim of our study is to correlate the hippocampal volumes and the duration of recovery and discharge after propofol sedation in the patients undergoing magnetic resonance imaging (MRI) from the post procedure observation room.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 5.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •All patients who need sedation to undergo brain MRI, aged between 5 and 60 years.
- •Patients who will require both spine and brain MRI (with spine pathology).
- •Patients receiving sedation for 20 to 60 minutes duration.Â.
排除标准
- •Refusal to provide informed consent Patients with identified causes of delayed waking up like hypothyroidism, hyponatremia Na (<135 mEq/L) [3], hypernatremia Na >145 mEq/L [9], hypo/hyperglycemia, hypothermia with axillary temperature < 350C. Patients with known liver and/or renal dysfunction.
- •(Defined as elevated or aspartate amino-transferase/ alanine amino-transferase > 5 times [10] when reports are available, serum creatinine >1.2 mg/dL) [11] Patients on inotropic support.
- •Patients who are intubated.
- •Patients with motor component of Glasgow Coma Scale (GCS) ≤ 5 and eye component < 4 Patients diagnosed with intracranial space occupying lesions.
- •Patients post intracranial surgeries/ resection surgeries.
结局指标
主要结局
Assessment of recovery is made without any stimulation (tactile or noxious). Time to spontaneous eye opening and limb movement by the patients will be recorded from the time of stoppage of infusion.
时间窗: 0, 5, 7, 9….. minutes from the stoppage of infusion ( i.e., 5 minutes after stoppage of the infusion, and every 2 minutes up to a point where the patient becomes fit for discharge )
The hippocampal volume will be calculated bilaterally in pre-contrast-volumetric MPRAGE sequence of brain imaging by the radiologist using Statistical Parametric Mapping.Â
时间窗: 0, 5, 7, 9….. minutes from the stoppage of infusion ( i.e., 5 minutes after stoppage of the infusion, and every 2 minutes up to a point where the patient becomes fit for discharge )
次要结局
- assessment of adequacy to discharge will be assessed as per the Modified Aldrete Score which tests the activity level at request.(0, 5, 7, 9….. minutes from the stoppage of infusion ( i.e., 5 minutes after stoppage of the infusion, and every 2 minutes up to a point where the patient becomes fit for discharge ))