Postoperative DeliriumNCT04707794
Incidence of Postoperative Delirium in Elderly Patients Undergoing Non-cardiac Surgery
An observational study of Postoperative Delirium, run by Sir Ganga Ram Hospital at 2 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postoperative Delirium
- What is being tested?
- Sevoflurane and Desflurane
- How many people
- 270 participants
- Where
- 2 sitesIndia
- Study dates
- 14 Jan 2021to Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients greater then 65 years age undergoing elective non-cardiac surgical procedures under general anesthesia
Who may be able to join
- Patients of age >65yrs
- Either sex
- ASA physical status 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.
Who cannot join
- 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
Show all 9Show fewer
- Preoperative haemoglobin < 8 gm % and serum albumin < 3.5mg/dl
- Patient inability to give informed consent
- Presence of preoperative delirium as assessed by 4A'S Test (score ≥ 4)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
India2 sites, 2 recruiting
- Recruiting
Sir Ganga Ram Hospital
New Delhi, National Capital Territory of Delhi, 110060
Nitin Sethi, DNB, 009142252523, nitinsethi77@yahoo.co.in
- Not yet recruiting
Sir Ganga Ram Hospital
New Delhi, 110060
P Muralikrishna, MBBS, 00911142252523, muralikrishna960@gmail.com
Bimla Sharma, MBBS, DGO, MD, FICA. MHA, 00911142252523, bimsharma1@gmail.com
About this study
Official title: The Incidence, Risk Factors and Outcome of Postoperative Delirium in Elderly Patients Undergoing Non-cardiac Surgery: a Prospective Observational Study
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,
- 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.
- 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
- 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
- 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.
- 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.
- 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.
- Postoperative pain will be assessed using the 10-point Numeric Rating Scale (NRS)
- Postoperative nausea and vomiting (PONV) It will be assessed using 3-point Likert scale (0- no nausea and vomiting, 1- nausea only, 2- vomiting)
- Length of stay in the hospital and any unanticipated ICU admission will be noted.
- All patients will be followed up postoperatively for 30-days and any occurrence of mortality will be noted.
- Conditions
- Postoperative Delirium
- Being tested
- Sevoflurane, Desflurane
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
Sevoflurane delivery will will be titrated to maintain anaesthesia depth of 50 (BIS score) using bispectral (BIS) index monitioring
DesfluraneDrug
Desflurane delivery will be titrated to maintain anaesthesia depth of 50 (BIS score) using bispectral (BIS) index monitioring
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Sevoflurane; Drug: Desflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From end of surgery till 24 hours postoperatively
Secondary outcomes (6)
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
Measured: From end of surgery till 24 hours postoperatively
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
Measured: From end of surgery till 24 hours postoperatively
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'
Measured: From end of surgery till 24 hours postoperatively
Length of hospital stay
The number of days the patient stays in the hospital post surgery till discharge will be recorded.
Measured: From end of surgery till discharge from the hospital
Unanticipated intensive care unit (ICU) admission
Any postoperative event necessitating ICU admission will be recorded
Measured: From end of surgery till 30 days postoperatively
Mortality
Any mortality occurring within 30 days of surgery will be recorded
Measured: From end of surgery till 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study start14 Jan 2021
- Primary completionAug 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sir Ganga Ram Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nitin Sethi, DNB, Sir Ganga Ram Hospital
- Investigators
- Nitin Sethi, MBBS, DNB, Principal investigator, Sir Ganga Ram HospitalBimla Sharma, MBBS, DGO, MD, FICA, MHA, Study chair, Sir Ganga Ram HospitalChand Sahai, MBBS, DA, MD, Principal investigator, Sir Ganga Ram HospitalJayashree Sood, MBBS, MD, FFRCA, PGDHHM, FICA, Study director, Sir Ganga Ram Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04707794
- Sponsor's protocol ID
- EC/12/20/1763
- Status last verified
- Apr 2026
- First submitted
- 12 Jan 2021
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incidence, Risk Factors and Outcome of Postoperative Delirium in Elderly Patients Undergoing Non-cardiac Surgery: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04707794
- Acronym / sponsor ID
- EC/12/20/1763
- Conditions
- Postoperative Delirium
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Sir Ganga Ram HospitalUniversity, hospital or other
- Study start
- 14 Jan 2021 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 13 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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,
- 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.
- 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
- 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
- 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.
- 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.
- 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.
- Postoperative pain will be assessed using the 10-point Numeric Rating Scale (NRS)
- Postoperative nausea and vomiting (PONV) It will be assessed using 3-point Likert scale (0- no nausea and vomiting, 1- nausea only, 2- vomiting)
- Length of stay in the hospital and any unanticipated ICU admission will be noted.
- All patients will be followed up postoperatively for 30-days and any occurrence of mortality will be noted.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elderly | – | Drug: Sevoflurane, Drug: DesfluranePatients > 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 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients greater then 65 years age undergoing elective non-cardiac surgical procedures under general anesthesia
Key inclusion criteria (6 listed)
- Patients of age >65yrs
- Either sex
- ASA physical status I - III
- Elective non-cardiac surgical procedures under general anesthesia
- Clinical Frailty Score (CFS): 1-8
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SevofluraneSevoflurane delivery will will be titrated to maintain anaesthesia depth of 50 (BIS score) using bispectral (BIS) index monitioring | Drug | Elderly |
| DesfluraneDesflurane delivery will be titrated to maintain anaesthesia depth of 50 (BIS score) using bispectral (BIS) index monitioring | Drug | Elderly |
Primary outcome
Incidence of postoperative delirium
Time frame: From end of surgery till 24 hours postoperatively
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
6 secondary outcomes
Postoperative Sedation
Time frame: From end of surgery till 24 hours postoperatively
Postoperative Pain
Time frame: From end of surgery till 24 hours postoperatively
Postoperative nausea and vomiting
Time frame: From end of surgery till 24 hours postoperatively
Length of hospital stay
Time frame: From end of surgery till discharge from the hospital
Unanticipated intensive care unit (ICU) admission
Time frame: From end of surgery till 30 days postoperatively
Mortality
Time frame: From end of surgery till 30 days postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: No
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Lactium Premedication to Prevent Emergence Agitation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Delirium, run by Sir Ganga Ram Hospital at 2 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bimla Sharma, MBBS, DGO, MD, FICA, MHA (00911142252523, bimsharma1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative delirium (time frame: From end of surgery till 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.