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efficacy of oral gabapentin and melatonin on post operative delirium

The efficacy of oral Gabapentin with Melatonin on post operative delirium in patients undergoing major non-cardiac surgery under entropy guided general anaesthesia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/02/039963
Enrollment
120
Registered
2022-02-02
Start date
Unknown
Completion date
Unknown
Last updated
2022-02-21

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Gabapentin and melatonin: Tablet Gabapentin :300mg PO , pre op and for 3 days in post op period Tablet melatonin : 3mg PO, pre op and for 3 days in post op period Control Intervention1

Sponsors

Dr Ankur Upadhyay
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All ASA 1-2 patients ,aged 50 years and above of either sex, foe elective non cardiac surgery under GA where enteral feeding can be started < 12 hrs

Exclusion criteria

Exclusion criteria: Patients in which gastric surgery was done and patients who are to be kept NPO for >24 hrs ASA grade III and IV. History of schizophrenia, epilepsy or parkinsons disease,OSA for a period of one year. Visual ,hearing, language or other barriers which hampers communication or preoperative delirium assessment Neurosurgery or traumatic brain injury Severe hepatic dysfunction Renal failure Patients where baseline CAM is positive Patients aged less than 50 years.

Design outcomes

Primary

MeasureTime frame
To see the prevalence and severity of delirium in postoperative period. And on the first three days post op.Timepoint: Preoperative day Post op : Day 1 Day 2 Day 3

Secondary

MeasureTime frame
1. Subjective sleep quality of the patient in the postoperative period by Stanford sleepiness scale. 2. Cumulative analgesic consumption in 3 post operative days Timepoint: 1 year

Countries

India

Contacts

Public ContactDr Ankur Upadhyay

Indira Gandhi medical College , Shimla

pathaniajyoti7@gmail.com9418120659

Outcome results

None listed

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