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Role of NIRS to compare the oxygen level between opioid and cognitive function in elderly patients after surgery

Utilization of NIRS Monitor to Compare Regional Cerebral Oxygen Saturation Between Opioid and Opioid-Sparing Anesthesia and Post-Operative Cognitive Dysfunction in Elderly Patients Undergoing Laparoscopic Surgery: A Double-Blinded Randomized Controlled Trial - NA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/02/080761
Enrollment
100
Registered
2025-02-18
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F112- Opioid dependence

Interventions

Intervention1: Opioid Based (Group A):: Opioid anesthesia- propofol (1-2 mg/kg), fentanyl (1-2 g/kg), and atracurium (0.5 mg/kg) will be administered from pre-surgery to the end of surgery. Control

Sponsors

Dr Puneet Khanna
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.)Age above 60 years. 2.) Undergoing major surgery over 60 minutes. 3.) Can give informed consent themselves. 4.) Minimum cognitive performance required to participate is ACE-III score more than 88.

Exclusion criteria

Exclusion criteria: 1.) Patients with a history suggestive of dementia (either listed in the medical record or reported by the patient) or any neurological disorder 2.) History of alcohol abuse, chronic opioid or other substance abuse. 3.) History of any cerebral surgeries, stroke. 4.) History suggestive of psychiatric disease like schizophrenia, dementia, anxiety or other disorder affecting cognition, mental dysfunction. 5.) Prescription of central nervous system – active medications (e.g.: antidepressants antipsychotics, sedatives).

Design outcomes

Primary

MeasureTime frame
1.The association between NIRS and the incidence of POCD in patients. 2.Measurement of cerebral hypoperfusion between opioid and opioid-sparing anesthesia groups. Timepoint: 1.) Postoperative delirium- Immediately post operatively and 24 hours post operatively. 2.) Post operative cognitive dysfunction- 24 and 48 hours post operatively, at 30 days post operatively. 3.)Cerebral Oxygenation- 10 minutes intra operatively

Secondary

MeasureTime frame
Incidence of POCD between opioid and opioid-sparing anesthesia groups.Timepoint: 24 hrs Post-operative(ACE-III)

Countries

India

Contacts

Public ContactDr Puneet Khanna

All India Institute of Medical Science (AIIMS), New Delhi.

k.punit@yahoo.com9873106516

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026