cognitive screening of patients before anaesthesia to predict post operative confusion

Not yet recruiting

• Conditions: Delirium due to known physiological condition,

• Registration Number: CTRI/2023/09/058047
• Lead Sponsor: DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE, K. S. HEGDE MEDICAL ACADEMY

Brief Summary

After approval from the Institutional EthicsCommittee, patients satisfying the inclusion criteria will be enrolled afterobtaining informed written consent.

During pre-anaesthetic evaluation on the daybefore surgery, study subjects will be given the MiniCog screening test. TheMiniCog consists of a 3-word registration and recall test for memory and aclock drawing test for distraction. The exam begins with asking the patient torepeat a list of three predetermined words. The patient is then asked to draw aclock and then recollect the three words. The maximum test score is 5, andpoints are deducted for each incorrect word recall or incorrect clock drawing.A MiniCog score ≤ 2 indicates probable cognitive impairment.

The patients will be evaluated using the HMSEscale in addition to the MiniCog. It is a reliable tool for assessing cognitivedeterioration. HMSE score ≤23 indicates probable cognitive impairment.

  In the PACU, patients will be evaluated forlevel of arousal using the Richmond Agitation and Sedation Scale (RASS) and fordelirium using Confusion Assessment Method (CAM). This will be done once the patient reaches an Aldrete score of ≥9,indicating appropriate level of wakefulness, hemodynamic and respiratorystability for discharge to wards.22 CAM will be carried out twice,first on postoperative day zero and second on postoperative day one.

The RASS is a validated measure of arousaland level of consciousness, which has been shown to be effective in multipleclinical settings. The RASS is scored on a 10-point scale, with scores of 1–4indicating increasingly high degrees of anxiety or agitation, a score of 0indicating a calm and alert state, and scores between −1 and −5 indicatingvarious levels of sedation, with −5 indicating that a patient is unarousable.

CAM is a validated measure of delirium thathas been used in several hospital settings. The instrument addresses thefollowing features: (1) acute onset or fluctuating course, (2) inattention, (3)disorganized thinking, and (4) altered level of consciousness. A positivediagnosis of delirium by the CAM requires the presence of features (1) and (2)and either (3) or (4).

Additional recorded data includes demographiccharacteristics (age, sex, education level), smoking or alcohol use,comorbidities, presence of sleep disturbances and visual or hearing impairment,ASA physical status, surgical specialty, duration of NPO, type of anaesthesia,intraoperative medications used, whether minimally invasive surgery or not and  duration of anaesthesia.

After evaluation with CAM, if patient isfound to have delirium, any confounding factors detected will be addressedimmediately and the patient will be managed as per the institutional protocols.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-09-23
• Study Start: 2023-10-16

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 117

Inclusion Criteria

Patients undergoing elective surgery.

Exclusion Criteria

• Patients who are not willing to enroll for the study.
• Patients with preexisting psychiatric illness.
• Patients with preexisting dementia and known cognitive dysfunction.
• Patients who are in the ICU.
• Planned post-operative ICU admission.
• Patients who won’t be able to perform MiniCog and HMSE test.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Detect undiagnosed cognitive impairment in elderly patients using MiniCog & HMSE.	During pre-anaesthetic evaluation on the day before surgery, study subjects will be given the MiniCog & HMSE tests. In the PACU, patients will be evaluated for level of arousal using the Richmond Agitation & Sedation Scale (RASS) and for delirium using Confusion Assessment Method (CAM). This will be done once the patient reaches an Aldrete score of more than or equal to 9, indicating appropriate level of wakefulness, hemodynamic and respiratory stability for discharge to wards.

Secondary Outcome Measures

Name	Time	Method
To determine whether patients with low MiniCog or HMSE scores in the pre-operative period are at higher risk of developing post-operative delirium.	To identify other factors which affect post-operative delirium.

Trial Locations

Locations (1)

K. S. HEGDE MEDICAL ACADEMY; 🇮🇳 Kannada, KARNATAKA, India

K. S. HEGDE MEDICAL ACADEMY

🇮🇳Kannada, KARNATAKA, India

ARUN V

Principal investigator

9895529700

arunvasudevrajkumar@gmail.com