Comparative analysis of isoflurane and propofol based total intravenous anaesthesia for postoperative delirium in young adults undergoing laparoscopic cholecystectomy
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- A prospective randomised control trial to compare the incidence of post operative delirium following laparoscopic cholecystectomy under Isoflurane inhalational anaesthesia and Propofol based Total Intravenous Anaesthesia.
研究概览
简要总结
This study is a double-blinded prospective randomized controlled trial comparing the effectiveness of Isoflurane inhalation anaesthesia and Propofol-based Total Intravenous Anesthesia (TIVA) for post operative delirium in young female patients (aged 18-40 years) undergoing laparoscopic cholecystectomy. The study will be conducted in the Department of Anaesthesiology at the Institute of Medical Sciences, Banaras Hindu University, Varanasi. The primary outcome will be the incidence of postoperative delirium within the first two days after surgery, assessed using the Confusion Assessment Method (CAM). Secondary outcomes include observation of duration , severity , type of delirium within first 2 post operative days and assessment of pain using the Visual Analog Scale (VAS) at 2, 6, 12 and 24 hours post operatively and documenting the frequency and dose of Opioid rescue medication ( Morphine or Tramadol) for break through pain if needed post operatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •ASA 1 and ASA 2 patients
- •Patients scheduled for laparoscopic cholecystectomy
- •Patients between age 18 to 40 years of age and female sex
- •Written informed consent.
排除标准
- •Presence of pre existing cognitive or neurological disorders.
- •Presence of emergencies or urgent surgeries.
- •History of substance abuse or dependence.
- •Presence of significant comorbidities e.g. severe cardiovascular disease, renal failure, advanced hepatic dysfunction, uncontrolled diabetes mellitus, severe respiratory disease, uncontrolled hypertension.
- •ASA grade 3 and 4
- •Pregnant or breast feeding
- •Concurrent surgeries
- •Inability to provide informed consent or participate in follow up.
- •Intra operative conversion to open cholecystectomy.
- •Receipt of regional anaesthesia techniques along side general anaesthesia.
结局指标
主要结局
A prospective randomised control trial to compare the incidence of post operative delirium following laparoscopic cholecystectomy under Isoflurane inhalational anaesthesia and Propofol based Total Intravenous Anaesthesia.
时间窗: The primary outcome will be the incidence of delirium with in first 2 post operative days. The delirium will be assessed by Confusion Assessment Method once a day between 3 pm to 5 pm. If the patient is discharged with in 2 days after surgery, the last assessment will be performed on the day of discharge.
次要结局
- 1. To observe duration , severity and type of post operative delirium.(2. To assess the post operative pain.)
研究者
Naven Baabu S
Banaras Hindu University Varanasi