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A clinical trial to study the effect of melatonin in prevention of postoperative delirium in patients undergoing bypass surgeries for chronic limb ischaemia.

A placebo controlled double-blind randomized clinical trial to study the effect of melatonin in prevention of post-operative delirium in patients undergoing reperfusion surgery for chronic limb ischaemia. - nil

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/07/071135
Enrollment
100
Registered
2024-07-23
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Health Condition 1: I739- Peripheral vascular disease, unspecified

Interventions

Intervention1: Melatonin: Patient will receive melatonin 3mg on two consecutive evenings, on the evening before surgery and one day prior to the day before surgery (at seven p.m.). Control Interventio

Sponsors

Dr Basudev Pati
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All patients in the age group of 40 to 75 years of age undergoing reperfusion surgery or bypass procedure for chronic limb ischaemia. The bypass procedure could be aorto-femoral, femoro-popliteal or aorto-femoro-popliteal bypass.

Exclusion criteria

Exclusion criteria: Patients with known psychiatric disorders. Pychotropic drugs consumption. Patients on anticonvulsants. History of ongoing substance abuse. Severe anemia. Severe copd or asthma. CKD stage 3 and above. History of cerebrovascular disease. Sensory disorders including blindness,hearing loss, cognitive disorders and dementia. Patients not extubated on the table and reintubated within the duration of study period.

Design outcomes

Primary

MeasureTime frame
To report the incidence of delirium between melatonin and placebo group.Timepoint: post operative day 1 till post operative day 5

Secondary

MeasureTime frame
Duration of delirium. Severity of delirium. Length of hospital stay. Total dose of haloperidol and benzodiazepines administered during delirium. In hospital mortality rate. ICU admittance and length of stayTimepoint: 5 days or 120 hours

Countries

India

Contacts

Public ContactDr Sanjay Kumar Jaswal

PGIMER,Chandigarh

sanjayjaswal247@gmail.com09779170944

Outcome results

None listed

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