Assessment of Immediate Postoperative Delirium (IPD) in Adult Patients: Incidence, Implication of Type of Anesthesia and Identification of Other Etiological Factors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 402
- 试验地点
- 1
- 主要终点
- Onset of Immediate postoperative delirium (IPD) in adult patients
研究概览
简要总结
Delirium is considered to be acute failure of central nervous system. It is acute confusional state characterized by decline from baseline mental level, attention deficit and disorganized thinking.
Postoperative delirium is known to prolong length of stay in hospital, cause functional decline and dementia, increase all-cause mortality and increase the medical cost. It is also associated with other outcomes like cardiac arrest, ventricular tachycardia or fibrillation, myocardial infarction, pulmonary edema, pulmonary embolism, bacterial pneumonia, respiratory failure requiring intubation, renal failure requiring dialysis and stroke.
There are well known predisposing and precipitating factors related to its etiology. However, the effect of type of anesthesia is not very clear. There have been no major clinical trials in this part of the world to delineate the incidence of immediate postoperative delirium (IPD). The investigators have undertaken this prospective observational study to determine the incidence of IPD and its etiological factors in adult patients during their stay in the Post-Anesthesia Care Unit (PACU) following surgery under different types of anesthesia (general anesthesia, regional anesthesia and monitored anesthesia care). The study was done over a period of about three months.
Assessment for delirium was done using Confusion Assessment Method-Intensive Care Unit (CAM-ICU score, English/Arabic version). Sedation and Agitation were assessed using Richmond Agitation Sedation Score (RASS). Pain was assessed using Numeric Pain Score (NPS). Assessment was done within 24 hours prior to surgery and was repeated at three different intervals in PACU. Details of perioperative management were recorded and analyzed. The incidence of IPD and its etiologic factors were identified thereby leading to corrective action.
详细描述
Decision to perform this observational study was made due to the lack of information on the local incidence and risk factors for the development of immediate postoperative delirium (IPD).
A literature review was done to study the already implicated perioperative causative factors as well as other significant perioperative factors.
A consultant neurologist was contacted to confirm the appropriateness of using CAM-ICU, RASS and NPS as assessment tools for the study. Doctors and nurses were trained on the proper use of the assessment tools using educational material at www.icudelirium.org. Permission was obtained from the author who has done validation of arabic version of CAM-ICU score. A proforma was prepared and local Ethical committee approval was obtained.
A pilot study of 24 cases showed the incidence of IPD to be about 25%. The investigators expected to have a total of 600 adult cases undergo anesthesia during the study period of three months. Based on a population size of 600 patients, a level of confidence of 95% and an error of 10% on either side, the optimum sample size was calculated as 395 patients.
The details of the study were explained to each patient with help of information sheet by a dedicated nurse and a doctor well versed in local language. After patient agreement, a written informed consent was obtained. The preoperative scoring of pain, anxiety and agitation and delirium was done by a dedicated nurse under supervision of a doctor who was not involved in providing anesthesia to the patient. Pain was assessed using NPS, sedation/agitation/anxiety using RASS and delirium using CAM-ICU score.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (more than 18 years old) scheduled for Elective and Emergency surgery under anaesthesia.
- •Adult patients with ASA- 1 2 or 3 status (American Society of Anaesthesiologists Risk Stratification),
- •Patients getting anesthesia: general, regional and monitored anesthesia care.
- •Patients undergoing open/laparoscopic/endoscopic surgery.
排除标准
- •Refusal to consent
- •Patients with ASA- 4 and above risk stratification. Critically ill and unstable patients, shifted from ICU setting and for Emergency surgery.
- •Patients with neurological conditions like dementia, psychosis, depression, stroke, head injury and any other pre-existing neurological disease which may interfere with the assessment of delirium.
- •Extubation in deep plane of anesthesia where patient is not responsive to verbal commands.
- •Deaf and dumb patients
- •Inability to comprehend patient language.
研究组 & 干预措施
No Delirium
No Delirium: CAM-ICU score of less than 3 throughout Post-Anesthesia Care Unit stay
干预措施: Types of Anesthesia (Procedure)
No Delirium
No Delirium: CAM-ICU score of less than 3 throughout Post-Anesthesia Care Unit stay
干预措施: Access of Surgery (Procedure)
No Delirium
No Delirium: CAM-ICU score of less than 3 throughout Post-Anesthesia Care Unit stay
干预措施: Comorbidities (Other)
No Delirium
No Delirium: CAM-ICU score of less than 3 throughout Post-Anesthesia Care Unit stay
干预措施: Preoperative Medication (Drug)
No Delirium
No Delirium: CAM-ICU score of less than 3 throughout Post-Anesthesia Care Unit stay
干预措施: Routine blood test (Diagnostic Test)
Initial Delirium
Initial Delirium: CAM-ICU score of 3 or more at 15 minutes following end of anesthesia and/or at 30 minutes following end of anesthesia
干预措施: Types of Anesthesia (Procedure)
Initial Delirium
Initial Delirium: CAM-ICU score of 3 or more at 15 minutes following end of anesthesia and/or at 30 minutes following end of anesthesia
干预措施: Access of Surgery (Procedure)
Initial Delirium
Initial Delirium: CAM-ICU score of 3 or more at 15 minutes following end of anesthesia and/or at 30 minutes following end of anesthesia
干预措施: Comorbidities (Other)
Initial Delirium
Initial Delirium: CAM-ICU score of 3 or more at 15 minutes following end of anesthesia and/or at 30 minutes following end of anesthesia
干预措施: Preoperative Medication (Drug)
Initial Delirium
Initial Delirium: CAM-ICU score of 3 or more at 15 minutes following end of anesthesia and/or at 30 minutes following end of anesthesia
干预措施: Routine blood test (Diagnostic Test)
Delirium
Delirium: CAM-ICU score of 3 or more immediately prior to discharge from Post-Anesthesia Care Unit
干预措施: Types of Anesthesia (Procedure)
Delirium
Delirium: CAM-ICU score of 3 or more immediately prior to discharge from Post-Anesthesia Care Unit
干预措施: Access of Surgery (Procedure)
Delirium
Delirium: CAM-ICU score of 3 or more immediately prior to discharge from Post-Anesthesia Care Unit
干预措施: Comorbidities (Other)
Delirium
Delirium: CAM-ICU score of 3 or more immediately prior to discharge from Post-Anesthesia Care Unit
干预措施: Preoperative Medication (Drug)
Delirium
Delirium: CAM-ICU score of 3 or more immediately prior to discharge from Post-Anesthesia Care Unit
干预措施: Routine blood test (Diagnostic Test)
结局指标
主要结局
Onset of Immediate postoperative delirium (IPD) in adult patients
时间窗: During PACU stay up to 2 hours.
Incidence of Immediate postoperative Delirium during Post-Anesthesia-Care-Unit (PACU) stay (at either 15 minutes or 30 minutes after end of anesthesia) as well as at the time of discharge from PACU
Implication of Type of Anesthesia on incidence of Immediate Postoperative Delirium
时间窗: Intraoperative period
Includes General Anesthesia (Inhalational as well as Total intravenous anesthesia), Regional Anesthesia and Monitored anesthesia care
Effect of Perioperative risk factors on incidence of Immediate Postoperative Delirium
时间窗: Perioperative period prior to delirium assessment.
Perioperative risk factors include: Electrolyte imbalance, anemia, co-morbidities like diabetes, hypertension, ischemic heart disease, chronic kidney diseases etc, preoperative medications like antihypertensives, oral hypoglycemics, insulin, antiplatelets, etc. All details of perioperative management were recorded.
次要结局
- Percentage of cases requiring Postoperative Delirium treatment(Postoperative period up to 8 weeks)
- Postoperative Length of stay(Postoperative period up to 8 weeks)
- Postoperative Complications(Postoperative period up to 8 weeks)
- Mortality rate(Postoperative episode up to 8 weeks)