Sevoflurane
DrugSevoflurane delivery will will be titrated to maintain anaesthesia depth of 50 (BIS score) using bispectral (BIS) index monitioring
NCT Number: NCT04707794
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.
Interested in participating?
Request Info65 year and older
All sexes
Observational
Sir Ganga Ram Hospital, New Delhi, National Capital Territory of Delhi, India
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,
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
Time frame: From end of surgery till 24 hours postoperatively
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
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
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 discharge from the hospital
The number of days the patient stays in the hospital post surgery till discharge will be recorded.
Time frame: From end of surgery till 30 days postoperatively
Any postoperative event necessitating ICU admission will be recorded
Time frame: From end of surgery till 30 days postoperatively
Any mortality occurring within 30 days of surgery will be recorded
Time frame: From end of surgery till 24 hours postoperatively
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
Contact information is provided by the study sponsor or research team.
Bimla Sharma, MBBS, DGO, MD, FICA, MHA
CONTACT
Nitin Sethi, MBBS, DNB
CONTACT
Sir Ganga Ram Hospital
Other
The Incidence, Risk Factors and Outcome of Postoperative Delirium in Elderly Patients Undergoing Non-cardiac Surgery: a Prospective Observational Study
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