Incidence of Postoperative Delirium in Elderly Patients Undergoing Non-cardiac Surgery

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorSir Ganga Ram Hospital

About this trial

Postoperative delirium (POD) is the most common adverse neurologic complication that can occur in patients of any age. Its incidence varies across age groups and is substantially influenced by patient-related risk factors. POD occurs in 17%-61% of major surgical procedures. Several risk factors which contribute to the development of POD include age more than 60 years, pre-existing cognitive dysfunction, presence of comorbidities, sensorial deficits, malnutrition, polypharmacy, impaired physical mobility and frailty. Postoperative delirium has several wide ranging and adverse outcomes that are consistently associated with delirium such as mortality, increased length of hospital stay, and increased hospital costs. A recently devised tool for rapid assessment of delirium is the 4 A's test. It has now been validated for identifying delirium in the surgical population. The proposed prospective observational study will be conducted on 150 patients belonging to ASA Physical Status I-III of either sex, scheduled to undergo non-cardiac surgery under general anaesthesia (GA), requiring at least 24 hours of postoperative inpatient care. This prospective, observational study aims to evaluate the incidence, risk factors and outcomes of postoperative delirium in elderly patients more than 65 years of age undergoing non-cardiac surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients of age >65yrs

Either sex

ASA physical status I - III

Elective non-cardiac surgical procedures under general anesthesia

Disqualifiers

Clinical Frailty Score (CFS) of 9

Patients diagnosed with dementia, severe psychiatric or neurological diseases

Recent surgery within past 3-months

History of recent head injury in the preceding 3 months

Trial population

Patients greater then 65 years age undergoing elective non-cardiac surgical procedures under general anesthesia

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Sevoflurane

    Drug

    Sevoflurane delivery will will be titrated to maintain anaesthesia depth of 50 (BIS score) using bispectral (BIS) index monitioring

  • Desflurane

    Drug

    Desflurane delivery will be titrated to maintain anaesthesia depth of 50 (BIS score) using bispectral (BIS) index monitioring

Treatment groups

270 Participants
are divided into 1 treatment group
Group A: Elderly2 interventions

Trial outcomes

Primary outcomes

1

Incidence of postoperative delirium

Postoperative delirium will be assessed using 4 A's test.A score of 0 suggests absence of delirium or severe cognitive impairment, score 1-3 suggests presence of possible cognitive impairment, and a score \> 4 suggests the presence of delirium/ cognitive impairment

Time frame
From end of surgery till 24 hours postoperatively

Secondary outcomes

1

Postoperative Sedation

Postoperative sedation will be assessed using the 10 point Richmond Agitation and Sedation Scale. +4 suggests overtly combative \& violent, 0 suggests awake \& quiet, and -5 suggets no response to voice or physical stimulation

Time frame
From end of surgery till 24 hours postoperatively
2

Postoperative Pain

It will be assessed using the 10-point Numeric Rating Scale (NRS). A score of 0 suggests 'no pain'and score of 10 suggests 'maximum pain'experienced

Time frame
From end of surgery till 24 hours postoperatively
3

Postoperative nausea and vomiting

It will be assessed using 3-point likert scale. A score of 0 suggests 'no nausea \& vomiting'and a scoe of 2 suggests 'nausea \& vomiting present'

Time frame
From end of surgery till 24 hours postoperatively
4

Length of hospital stay

The number of days the patient stays in the hospital post surgery till discharge will be recorded.

Time frame
From end of surgery till discharge from the hospital

Other outcomes

1

Correlation of risk factors with postoperative delirium

Correlation between age more than 75 years, frailty, cognitive dysfunction, impaired physical mobility, comorbidity and polypharmacy with postoperative delirium will be assessed using multivariate or univariate analysis as applicable

Time frame
From end of surgery till 24 hours postoperatively

Sponsors and contacts

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