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临床试验/CTRI/2025/11/097039
CTRI/2025/11/097039尚未招募不适用

A randomized comparative study to evaluate the effects of propofol versus desflurane on postoperative cognitive dysfunction in elderly patients undergoing elective spine surgeries under general anesthesia at Sawai Man Singh medical college Jaipur

Department of Anaesthesiology Sawai Man Singh medical college and attached hospitals Jaipur1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2026年1月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
150
试验地点
1
主要终点
Mean POCD (Post Operative Cognitive Dysfunction) Score

研究概览

简要总结

Postoperative Cognitive Dysfunction refers to a condition where patients experience a decline in cognitive function after undergoing surgery. This decline can manifest as problems with memory, attention, concentration, and overall cognitive abilities. POCD is particularly observed in elderly patients, although it can also affect younger individuals. The duration of POCD can vary from a few days to several weeks or months post-surgery. Among the various factors influencing POCD, the choice of anaesthetic agents has garnered considerable attention in recent research. Use of intravenous and inhalational anaesthetic agents as maintenance anaesthesia have been extensively studied in relation to Postoperative Cognitive Dysfunction (POCD), reflecting their widespread use in surgical procedures and potential impact on cognitive function. In this study, we prospectively evaluate the effects of propofol versus desflurane on Post Operative Cognitive Dysfunction in elderly patients undergoing elective spine surgeries. This study will be conducted in two groups(Group A and Group B). Each group consists of 75 patients. Group A patients will receive propofol as maintenance anaesthetic agent and Group B patients will receive desflurane as maintenance anaesthetic agent.

Patient will be identified, PAC will be checked, MOCA(Montreal Cognitive Assessment) test will be done to get pre operative MOCA score, informed written consent will be taken and patient will be taken inside the OT. Pre-operative vitals (PR, NIBP, ECG, SpO2) will be recorded. IV fluids will be started through already secured IV line as per hospital protocol.Premedication will be given with Inj. Midazolam 0.05mg/kg IV, Inj. Glycopyrrolate 0.005mg/kg IV, Inj. Fentanyl 2 µg/kg  IV. Patient will be induced with Inj. Thiopentone(5-7mg/kg) IV + Inj. Rocuronium(0.6-1.2mg/kg) IV. Airway will be secured with Endotracheal Tube of appropriate size. Group A (N= 75) patients will receive propofol 50-200mcg/kg/min as maintenance anaesthesia along with N2O:O2(50:50) titrated to maintain BIS score between 40-60. Group B(N=75) patients will receive desflurane 2.5-8.5% as maintenance anaesthesia along with N2O:O2(50:50) titrated to maintain BIS score between 40-60. Hemodynamic parameters will be recorded throughout the surgery at fixed intervals. At the end of surgery, patient will be reversed with Inj. Neostigmine 0.06mg/kg and Inj. Glycopyrrolate 0.001mg/kg IV. Patient will be extubated after the patient is satisfying extubation criteria. Additionally, 4 mg of ondansetron will be administered to prevent postoperative nausea and vomiting and patients will be transferred to the post-anaesthesia care unit (PACU). Data collection after one week of surgery using MOCA(Montreal Cognitive Assessment) Score will be done and recording incidence of POCD, mean POCD score and score in various domains of cognitive function.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
60.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Patients who are all scheduled for elective spine surgeries
  • Patients giving informed written consent to the study
  • Patients of age more than 60 years
  • Patients belonging to American Society of Anaesthesiologists class 1, 2 and 3.

排除标准

  • Known case of psychiatric diseases and cognitive dysfunction
  • Patients with a history of drug abuse
  • Postoperative intubated or tracheostomized after one week of surgery
  • Patients who are unable to comprehend the questionnaire
  • Patients with a history of multiple previous surgeries
  • Patients should not be a part of any other study.

结局指标

主要结局

Mean POCD (Post Operative Cognitive Dysfunction) Score

时间窗: 1 Week after the surgery

次要结局

  • 1. Incidence of POCD(2. Mean score in various domains of cognitive function(Executive, Naming, Attention, Language, Abstraction, Recall, Orientation))

研究者

发起方
Department of Anaesthesiology Sawai Man Singh medical college and attached hospitals Jaipur
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Neelu Sharma

Sawai Man Singh medical college and attached hospitals

研究点 (1)

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