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
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.
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,
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 →Sir Ganga Ram Hospital is the lead sponsor of 30 studies on the registry; 8 are open to participants now.
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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.
Exclusion Criteria:
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.
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.
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).
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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
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
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
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
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
Mortality
Any mortality occurring within 30 days of surgery will be recorded
Time frame: From end of surgery till 30 days postoperatively
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
Plan to share: No
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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.
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