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临床试验/CTRI/2026/01/100347
CTRI/2026/01/100347尚未招募2/3 期

Comparison of two methods Mini mental state examination (MMSE) vs Montreal cognitive assessment (MoCA) in diagnosing early postoperative cognitive disorders in elderly patients undergoing elective surgery under general anaesthesia.

Pt. B.D. Sharma PGIMS, Rohtak, Haryana- 1240011 个研究点 分布在 1 个国家入组 70 人开始时间: 2026年1月13日最近更新:
相关药物

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
To compare cognitive assessment results of elderly patients on MMSE and MoCA in order to

研究概览

简要总结

This study aims to comprehensively evaluate the Mini-Mental State Examination (MMSE) and the Montreal Cognitive Assessment (MoCA) in assessing early postoperative cognitive disorder in elderly patients undergoing elective surgery under general anaesthesia. Patients aged more than 60y scheduled for elective surgery under general anaesthesia will be recruited preoperatively. They will be administered MMSE and MOCA concurrently a day prior to surgery. The tests will be re administered within 48 hours postoperatively. Age, sex, education level, ASA grade, h/o cardiovascular disease and other comorbidities, type of surgery , site of surgery will be noted prior to administering the tests. Anaesthesia will be standardised using intravenous glycopyrrolate 0.01 mg/kg , intravenous propofol 2mg/kg, fentanyl 2mcg/kg and atracurium 0.5 mg/kg . Anaesthesia induction will be followed by endotracheal intubation or LMA insertion. Anaesthesia will be maintained according to the standard protocol of the department. Reversal will be carried out with combination of neostigmine(0.05 mg/kg) and glycopyrrolate(0.01 mg/kg). Surgical time and intraoperative blood loss will be noted during surgery. ) Patients’ preoperative demographic information (sex, age, level of education), comorbidities, preoperative cognitive status and site and type of surgery will be noted, intraoperative data comprising of anaesthesia technique, intraoperative blood loss, time of surgery and any specific episodes of hypotension, blood transfusions, cardiac arrythmias will be noted, Data on postoperative cognitive assessments and any complications will be collected postoperatively

研究设计

研究类型
干预性
分配方式
随机
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
60.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Patients aged more 60y scheduled for elective surgery under general anaesthesia will be recruited preoperatively.

排除标准

  • Patients who declined participation or were unsuitable for neurocognitive assessment, Previously diagnosed cognitive impairment, Severe visual/auditory impairments, Multiple procedures requiring anaesthesia scheduled during follow up, Illiterate patients or inability to comprehend.

结局指标

主要结局

To compare cognitive assessment results of elderly patients on MMSE and MoCA in order to

时间窗: The patients will be enrolled preoperatively. Patients more than 60 years undergoing elective surgery under general anaesthesia will be administered MMSE and MOCA concurrently a day prior to surgery. The tests will be re administered within 48 hours postoperatively. As our focus is on diagnosing early postoperative cognitive disorders so we will focus on assessing patients within 48 hours of surgery under anaesthesia.

assess early postoperative cognitive disorder after undergoing elective surgery under general

时间窗: The patients will be enrolled preoperatively. Patients more than 60 years undergoing elective surgery under general anaesthesia will be administered MMSE and MOCA concurrently a day prior to surgery. The tests will be re administered within 48 hours postoperatively. As our focus is on diagnosing early postoperative cognitive disorders so we will focus on assessing patients within 48 hours of surgery under anaesthesia.

anaesthesia.

时间窗: The patients will be enrolled preoperatively. Patients more than 60 years undergoing elective surgery under general anaesthesia will be administered MMSE and MOCA concurrently a day prior to surgery. The tests will be re administered within 48 hours postoperatively. As our focus is on diagnosing early postoperative cognitive disorders so we will focus on assessing patients within 48 hours of surgery under anaesthesia.

次要结局

  • To evaluate the predictive accuracy of MMSE & MoCA scores in identifying patients at risk of developing POCD(The patients will be enrolled preoperatively. Patients more than 60 years undergoing elective surgery under general anaesthesia will be administered MMSE & MOCA concurrently a day prior to surgery. The tests will be re administered within 48 hours postoperatively.Data will be compiled, compared & appropriate)
  • To assess the correlation among MMSE & MoCA in the perioperative setting for diagnosing cognitive impairment.(The patients will be enrolled preoperatively. Patients more than 60 years undergoing elective surgery under general anaesthesia will be administered MMSE & MOCA concurrently a day prior to surgery. The tests will be re administered within 48 hours postoperatively.Data will be compiled, compared & appropriate)
  • To identify which cognitive domains (e.g., memory, attention, executive function) show the(most significant decline postoperatively, & determine how well MMSE & MoCA capture)

研究者

发起方
Pt. B.D. Sharma PGIMS, Rohtak, Haryana- 124001
申办方类型
Government medical college
责任方
主要研究者
主要研究者

DR ANJU GHAI

Pt. B.D. Sharma PGIMS, Rohtak

研究点 (1)

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标识符

CTRI 编号
CTRI/2026/01/100347

日期

最近更新
(9个月前)