Comparison of Postoperative Delirium in Patients Anaesthetised With Isoflurane and Desflurane During Spinal Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Comparison of Postoperative Delirium With Isoflurane and Desflurane on Adults Undergoing Spine Surgery
研究概览
简要总结
Postoperative delirium (POD) is a known complication of inhalational agents used to anaesthetise patients for surgery with potential long term implications.The incidence of postoperative delirium in spine surgery is 3.3% to 3.8%.The purpose of this study is to compare the occurrence of postoperative delirium with inhalational anaesthetics namely isoflurane and desflurane in spine surgery patients.
详细描述
The patient will be randomized to receive isoflurane or desflurane anaesthesia prior to surgery. All the patients involved in the study will be blinded to group allocation. Screening for preoperative cognitive dysfunction will be done using the mini-cog test which includes a three word recall test and clock drawing test.The primary outcome variable will be assessment of delirium at day one and day three following surgery. Post operative delirium will be diagnosed using the 3D- CAM(Confusion Assessment Method) which tests for four features with a series of questions. The features include 1) acute onset and fluctuating course,2) inattention,3) disorganized thinking and 4) altered level of consciousness. Diagnosis of delirium is made if features 1 and 2 and either 3 or 4 are present. Similarly the severity of postoperative delirium will be assessed on day one and day three following surgery. Severity of postoperative delirium will be assessed using the CAM-S(Confusion Assessment Method-severity)long form delirium severity score.It assesses ten features including 1) acute onset and fluctuating course,2)inattention,3)disorganized thinking , 4)altered level of consciousness, 5) disorientation, 6)memory impairment ,7)perceptual disturbances ,8)psychomotor agitation, 9)psychomotor retardation and 10) altered sleep-wake cycle. The scores range from 0 to 19.
The demographic data of the patients,type and site of surgery will be noted. Preoperative hemoglobin, serum electrolytes and blood urea will be recorded. The intraoperative factors like duration of surgery and anaesthesia,use of intravenous fluids ,blood loss, number blood units transfused and opioid use will be studied at the time of surgery. The time to emergence and extubation following the completion of surgery will be noted.
The postoperative factors like postoperative pain, nausea and vomiting, fever,hemoglobin,serum electrolytes and blood urea will be noted.
Preoperative and postoperative pain will be assessed using the numerical rating score on a scale of one to ten.
The association of various preoperative,intraoperative and postoperative factors with POD will be determined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for spine surgery.
- •Age between 18-65 years
- •American Society of Anaesthesiologists (ASA) Grade I and II patients
- •Patients with Glasgow Coma Scale (GCS) of 15
- •Postoperative Aldrette score > 9
排除标准
- •Cardiorespiratory disorders
- •Associated cerebral disease
- •Psychiatric illness
- •Electrolyte and hormonal imbalance
- •History of drug abuse
- •Postoperative meningitis
- •Administration of high dose steroids
研究组 & 干预措施
Isoflurane
Isoflurane as an inhalational anaesthetic ,titrated with BIS ( bispectral index) /entropy monitoring,from start to end of surgery.
干预措施: Isoflurane (Drug)
Desflurane
Desflurane as an inhalational anaesthetic ,titrated with BIS ( bispectral index) /entropy monitoring,from start to end of surgery.
干预措施: Desflurane (Drug)
结局指标
主要结局
Comparison of Postoperative Delirium With Isoflurane and Desflurane on Adults Undergoing Spine Surgery
时间窗: 72 hours post surgery
Number of Participants who were Postoperative Delirium Positive (POD+) or Negative (POD-) After Undergoing Spine Surgery With Isoflurane or Desflurane using the confusion assessment method questionnaire on day three following surgery.
Comparison of Postoperative Delirium(POD) With Isoflurane and Desflurane on Adults Undergoing Spine Surgery
时间窗: 24 hours post surgery
Number of Participants who were Postoperative Delirium Positive (POD+) or Negative (POD-) After Undergoing Spine Surgery With Isoflurane or Desflurane using the confusion assessment method questionnaire on day one following surgery.
次要结局
- Post Operative Pain Scores With Isoflurane and Desflurane(72 hours post surgery)
- CAM-S Delirium Severity Score With Isoflurane and Desflurane(72 hours post surgery)
研究者
steve joys
Doctor
Post Graduate Institute of Medical Education and Research, Chandigarh