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NIRS Monitor to compare regional cerebral oxygen saturation between opioid and opioid free anesthesia and post operative cognitive dysfunction in elderly patients

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 - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/07/090909
Enrollment
100
Registered
2025-07-15
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Health Condition 1: K80- Cholelithiasis

Interventions

Intervention1: Anesthesia with opioids: Anaesthesia to be induced in all the patients with propofol 1 to 2 mg/kg, fentanyl 1- 2 microgms/kg and atracurium 0.5mg/kg Multimodal analgesia regimen to be u

Sponsors

All India Institute of Medical Sciences New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age above 60 years. 2. Either sex 3. Undergoing laparoscopic cholecystectomy over 60 minutes 4. ASA I-II 5. Can give informed consent themselves 6. Minimum cognitive performance required to participate is ACE-III score more than 88

Exclusion criteria

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 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 (eg: antidepressants, antipsychotics, sedatives)

Design outcomes

Primary

MeasureTime frame
To determine the association between opioids and frontal lobe hypoperfusion indicated by using NIRS.Timepoint: Baseline, every 10 minutes intraoperatively

Secondary

MeasureTime frame
To compare the incidence of post operative delirium 3. To determine the association between cerebral perfusion & incidence of postoperative cognitive dysfunction & delirium Timepoint: Baseline 24 hours post surgery 48 hours post surgery 30 days post surgery

Countries

India

Contacts

Public ContactPuneet Khanna

All India INSTITUTE of Medical Sciences New Delhi

k.punit@yahoo.com9873106516

Outcome results

None listed

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