OPIoid sparing Anesthesia Technique for supratentorial craniotomy in geriatric patients [OPIATE]: a randomized open labelled study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- 1.Time to emergence
研究概览
简要总结
Opioids have been an integral part of anesthesia practice and are not without side effects. Geriatric population have more pronounced opioid side effects during perioperative period which include, sedation, respiratory depression, shivering, nausea and vomiting, dizziness, constipation, pruritus and ileus. Specifically in geriatric patient undergoing neurosurgical procedures, increased sensitivity towards opioids, disturbed cerebral autoregulation in the postoperative period, coupled with opioid induced hypotension, respiratory depression and carbon dioxide retention leading to an undesirable rise in intracranial pressure and further sedation caused by these drugs may lead to a delayed emergence. In these patients time to emergence from anesthesia is important for rapid neurological examination. A depressed level of consciousness usually indicates residual anesthesia, most commonly due to an opioid overdose (bilaterally constricted pupils), but may be also be due to other causes, such as an intracranial hematoma, cerebral edema, nonconvulsive status epilepticus, hypoglycemia, electrolyte disturbances, hypothermia, pneumocephalus, vascular occlusion, and ischemia. Supratentorial tumors are the most common intracranial neoplasms in geriatric patients patients (>65 years). Important eloquent areas involved in speech, sensorimotor functions, white matter tracts and primary visual cortex, all are in supratentorial region. Resection of tumor that involve or are in close proximity to these areas are associated with a high risk of poor postoperative neurocognitive recovery, language dysfunction and motor weakness. While mild cognitive impairment and lethargy is not uncommon in geriatric patients in the immediate postoperative period, failure to awaken within 5- 10 minutes of cessation of anesthetic drugs should prompt a search for other potential causes of a delayed emergence. The practice of opioid sparing anesthesia [OSA] has the potential to innovate and transform the practice of neuroanesthesia and enhance the postoperative recovery profile, especially in geriatric patients. The OSA technique in the form of scalp block and combination of drugs such as dexmedetomidine, ketamine, lignocaine, magnesium etc can be used to preclude the use of opioids. With regard to postoperative recovery, presently there are no trials that have studied the effect of OSA in terms of time to emergence from cessation of anesthesia in geriatric patients undergoing supratentorial craniotomy surgery. The hypothesis of our study is that an OSA technique would be a better alternative to the conventional anesthetic technique using opioid throughout the surgery in geriatric neurosurgical patients undergoing craniotomy for supratentorial tumor surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 65.00 Year(s) 至 80.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Written informed consent 2.American Society of Anesthesiologists class I&II 3.Age of >65 years 4.Either gender 5.Supratentorial brain tumor with tumor diameter of ≤ 40 mm 6.Full Glasgow coma score (E4V5M6) 7.Estimated operative time of ≤ 6 hours and anesthesia time of ≤ 8 hours.
排除标准
- •1.Non consenting patient 2.Any history of previous brain surgery 3.Current or past history of any cardiac disease or medication 4.Any history of lung disease, liver or kidney dysfunction 5.Patients who had sensitivity to opioids, dexmedetomidine, ropivacaine 6.Body mass index of > 35 kg/m2 7.Preoperative cognitive dysfunction.
结局指标
主要结局
1.Time to emergence
时间窗: 1.From discontinuation of anesthetics to eye opening on command in minutes | 2. 10 minutes after extubation
2.Postoperative immediate pain
时间窗: 1.From discontinuation of anesthetics to eye opening on command in minutes | 2. 10 minutes after extubation
次要结局
- 4.Postoperative side effects: nausea,vomiting, shivering, hemodynamic instability, respiratory depression(Postoperative period[24 hrs])
- 5.Other respiratory parameters (any subclinical respiratory depression): Ph, PaO2, PaCo2, Hco3, Lact, Sao2, Hb(Postoperative period [24 hrs])
- 6.Time for first rescue analgesic:(Postoperative period [24 hrs])
- 7.Length of ICU stay
- 8.Length of Hospital stay
- 11.Intraoperative fentanyl consumption
- 1.Extubation time(1. From discontinuation of anesthetics to tracheal extubation in minutes)
- 2.Postoperative delirium(2.Assessed using CAM-ICU 60 minutes after extubation)
- 3.Postoperative early cognitive dysfunction(Assessed using MMSE 60 minutes after extubation])
- 9.Intraoperative brain relaxation [Cerebral relaxation score]
- 10.Intraoperative hemodynamic disturbances [hypotension, bradycardia]
