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

NCT04707794 | Recruiting DMC

• 1 other identifier: EC/12/20/1763
• Study Type: observational
• Target: 270
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Postoperative Delirium

Outcome Measures

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

  From end of surgery till 24 hours postoperatively

Secondary Outcomes (6)

• Postoperative Sedation

  From end of surgery till 24 hours postoperatively

• Postoperative Pain

  From end of surgery till 24 hours postoperatively

• Postoperative nausea and vomiting

  From end of surgery till 24 hours postoperatively

• Length of hospital stay

  From end of surgery till discharge from the hospital

• Unanticipated intensive care unit (ICU) admission

  From end of surgery till 30 days postoperatively

Other Outcomes (1)

• Correlation of risk factors with postoperative delirium

  From end of surgery till 24 hours postoperatively

Study Arms (1)

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 DRUG

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

Elderly

Desflurane DRUG

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

Elderly

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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 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)

Sponsors & Collaborators

• Sir Ganga Ram Hospital: lead

Study Sites (2)

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

MeSH Terms

Conditions

Emergence Delirium

Interventions

Sevoflurane; Desflurane

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Ethyl Ethers

Study Officials

• Nitin Sethi, MBBS, DNB

  Sir Ganga Ram Hospital

  PRINCIPAL INVESTIGATOR

• Bimla Sharma, MBBS, DGO, MD, FICA, MHA

  Sir Ganga Ram Hospital

  STUDY CHAIR

• Chand Sahai, MBBS, DA, MD

  Sir Ganga Ram Hospital

  PRINCIPAL INVESTIGATOR

• Jayashree Sood, MBBS, MD, FFRCA, PGDHHM, FICA

  Sir Ganga Ram Hospital

  STUDY DIRECTOR

Central Study Contacts

Bimla Sharma, MBBS, DGO, MD, FICA, MHA

CONTACT

00911142252523; bimsharma1@gmail.com

Nitin Sethi, MBBS, DNB

CONTACT

00911142252523; nitinsethi77@yahoo.co.in

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant & Associate Professor

Study Record Dates

• First Submitted: January 12, 2021
• First Posted: January 13, 2021
• Study Start: January 14, 2021
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (2)