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RecruitingNCT04707794Updated Apr 27, 2026

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

An observational study in Postoperative Delirium, sponsored by Sir Ganga Ram Hospital. Recruiting at 2 sites in India. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-04-27.

Sponsored by Sir Ganga Ram Hospital · Observational

From the registry’s dates

  • Started Jan 2021; still recruiting 5 years 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
270
Ages
65 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

The incidence of postoperative delirium (POD) following major surgery ranges from 17% to 61%.POD is the most frequent neurological complication that can occur in both the young and old, and its rate is considerably impacted by patient-related risk issues. The elderly population is believed to be more susceptible to POD, by virtue of being host to conditions such as a variety of comorbidities, malnutrition, concurrent cognitive dysfunction, frailty, sensorial and functional deficits, and polypharmacy.

Risk factors for delirium may be further identified as predisposing factors and precipitating factors. Predisposing factors are those that are present on admission and are not changeable, e.g. age, number and severity of co-morbid medical conditions, sensory impairment, history of cognitive impairment, sleep deprivation, immobility, and dehydration.Precipitating factors are those that trigger delirium while the patient is hospitalized. These may be infections, constipation, bladder catheterisation, procedures involving instrumentation, immobility, and sensory impairment

Postoperative delirium, especially in the elderly, significantly compromises patient recovery and imposes a heavy toll on patient well-being and the healthcare system. Postoperative delirium has several wide-ranging and adverse outcomes associated with it, such as mortality, increased length of hospital stay and increased hospital costs.

Several tools have been developed to track changes in mental status that could point to the onset of delirium. Among the tools employed for this purpose are the Sedation Scale, the Nursing-Delirium Screening Scale (Nu-DESC), and the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU).

However, there is a lack of consensus on the use of an appropriate tool to evaluate delirium in the postoperative period. The 4A's test is a screening instrument that has been designed for rapid and initial assessment of delirium. It has the added advantage of evaluating not only delirium but also postoperative cognitive dysfunction (POCD) which is the second most common complication in elderly surgical patients.

Delirium is a condition that is presumed to be avoidable in 30%-40% of cases which emphasizes the importance of attention to primary prevention.5 After the onset of delirium, little can be done to influence its duration, severity, or the possibility of recurrence. Thus, the necessity for identifying those at risk of developing postoperative delirium. It is imperative that hospitals should implement multimodal non-pharmacologic delirium prevention methods to identify and monitor patients at risk of developing this morbid condition.

There has been scant research in the developing world, including India in the sphere of postoperative delirium, a condition germane to practically all medical specialities and especially in the elderly population. Our study will research POD we expect to obtain evidence that will find the clinical application.

Our study will be focused on evaluating the incidence of POD in the elderly who will be posted for non-cardiac surgical procedures. We will also assess the association of postoperative delirium with risk factors such as frailty, cognitive dysfunction, impaired functional status, presence of comorbidities and polypharmacy. Other postoperative adverse events such as sedation, pain, postoperative nausea and vomiting will be recorded. Patient's length of stay in the hospital (LOS), any unanticipated ICU admission and mortality within 30 days will also be noted.

The following parameters will be recorded in all the patients,

  1. Postoperative delirium: It will be evaluated using 4 A's test, three times in the first 24 hours postoperatively. 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.
  2. Frailty: All eligible patients will be assessed preoperatively using the 9-point CFS. Score varies from 1-9 with fitness level very fit to terminally ill as depicted in the table
  3. Cognitive dysfunction: Preoperative cognition will be assessed using the 5-point Mini-cog test. A score \< 4 will be taken as cut-off for impaired cognitive function
  4. Impaired physical mobility: All preoperative mobile patients will be subjected to Timed Up and Go (TUG) test. A score of \<10 s is normal and score of \<20 s need assistance.
  5. Intraoperative hemodynamics (pulse, systolic blood pressure, diastolic blood pressure, and mean arterial blood pressure) will be recorded every 5-minutes intraoperatively and every 15-minutes postoperatively in the postoperative care unit (PACU) till discharge. A mean arterial blood pressure \<65 mmHg persisting for greater than 5-minutes despite treatment will be defined as an episode of intraoperative hypotension.
  6. Postoperative sedation:Sedation will be assessed postoperatively using the Richmond Agitation and Sedation Scale. Score varies from +4 to -5 and patient will be categorised from combative to unarousable as depicted in table.
  7. Postoperative pain will be assessed using the 10-point Numeric Rating Scale (NRS)
  8. Postoperative nausea and vomiting (PONV) It will be assessed using 3-point Likert scale (0- no nausea and vomiting, 1- nausea only, 2- vomiting)
  9. Length of stay in the hospital and any unanticipated ICU admission will be noted.
  10. All patients will be followed up postoperatively for 30-days and any occurrence of mortality will be noted.
02

Conditions studied

  • Postoperative Delirium

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03

In context

Emergence Delirium

751 studies on the registry are indexed under Emergence Delirium; 262 are open to participants now.

This study's planned enrollment of 270 is above the median of 162 across 279 observational studies indexed under Emergence Delirium.

Browse Emergence Delirium studies →

Lead sponsor

Sir Ganga Ram Hospital is the lead sponsor of 30 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients of age >65yrs
  • Either sex
  • I - III
  • Elective non-cardiac surgical procedures under general anesthesia
  • Clinical Frailty Score (CFS): 1-8
  • Patients requiring at least 24 hours of postoperative inpatient care.

Exclusion criteria

Exclusion Criteria:

  • 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
  • Patients with uncompensated cardiovascular disease, hepato-renal insufficiency and uncontrolled endocrine disease
  • Patients on anti-depressant, anti-anxiety, anti-convulsant and anti-parkinsonism medications
  • Preoperative \< 8 gm % and serum albumin \< 3.5mg/dl
  • Patient inability to give
  • Presence of preoperative delirium as assessed by 4A'S Test (score ≥ 4)
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
270 participants (estimated)
Patient registry
No

Groups and cohorts

  • Elderly

    Patients \> 65 years age undergoing non-cardiac surgery will be administered general anesthesia maintained with sevoflurane or desflurane titrated to maintain anaesthesia depth of 50 (BIS score) using bispectral (BIS) index monitioring

    Drug: Sevoflurane · Drug: Desflurane

Interventions

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

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

06

What researchers measure

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

  5. Unanticipated intensive care unit (ICU) admission

    Any postoperative event necessitating ICU admission will be recorded

    Time frame: From end of surgery till 30 days postoperatively

  6. Mortality

    Any mortality occurring within 30 days of surgery will be recorded

    Time frame: From end of surgery till 30 days postoperatively

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

07

Study locations

1 of 2 sites recruiting
  • Sir Ganga Ram Hospital
    New Delhi, National Capital Territory of Delhi 110060, India
    Recruiting
  • Sir Ganga Ram Hospital
    New Delhi, 110060, India
    Not yet recruiting
    • P Muralikrishna, MBBS · Contactmuralikrishna960@gmail.com · 00911142252523
    • Bimla Sharma, MBBS, DGO, MD, FICA. MHA · Contactbimsharma1@gmail.com · 00911142252523
    • Bimla Sharma, MBBS, DGO, MD, FICA. MHA · Principal investigator
    • P Muralikrishna Dr, MBBS · Principal investigator
    • Chand Sahai, MBBS, DA, MD, FICA · Principal investigator
    • Nitin Sethi, MBBS, DNB · Principal investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2021 (actual). Primary completion is estimated for Aug 2028, 91 months after the start.

Of 181 non-industry observational studies under Emergence Delirium, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 91 months is above that.

Counting every sponsor, half of 181 studies reached it within 21 months; a quarter within 10 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 12, 2021
First posted
Jan 13, 2021
StartActual
Jan 14, 2021
Primary completionEst.
Aug 2028
CompletionEst.
Sep 2028
Last update
Apr 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04707794
Lead sponsor
Sir Ganga Ram Hospital
Responsible party
Nitin Sethi, DNB (Senior Consultant & Associate Professor, Sir Ganga Ram Hospital) — Principal investigator
First posted
Jan 13, 2021
Start date
Jan 14, 2021
Primary completion
Aug 2028 (estimated)
Completion
Sep 2028 (estimated)
Last update
Apr 27, 2026

Study contacts

Bimla Sharma, MBBS, DGO, MD, FICA, MHA
Contact
bimsharma1@gmail.com
00911142252523
Nitin Sethi, MBBS, DNB
Contact
nitinsethi77@yahoo.co.in
00911142252523
Nitin Sethi, MBBS, DNB
principal investigator · Sir Ganga Ram Hospital
Bimla Sharma, MBBS, DGO, MD, FICA, MHA
study chair · Sir Ganga Ram Hospital
Chand Sahai, MBBS, DA, MD
principal investigator · Sir Ganga Ram Hospital
Jayashree Sood, MBBS, MD, FFRCA, PGDHHM, FICA
study director · Sir Ganga Ram Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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