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Comparison of two different doses of oral Melatonin in patients undergoing lower limb Orthopaedic surgeries to check anxiety before and after surgery and pain after surgery

To compare two doses of oral melatonin as premedicant in patients undergoing orthopaedic surgeries.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/05/042801
Enrollment
90
Registered
2022-05-25
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: M968- Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified

Interventions

Intervention1: Administration of oral Melatonin: three parallel groups are to be given 6mg oral melatonin, 12 mg oral melatonin and placebo respectively, 60-90 minutes prior to surgery. Control Interv

Sponsors

Department of Anaesthesiology and Critical Care Pt BD Sharma PGIMS Rohtak
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients undergoing lower limb orthopaedic surgeries under Spinal anaesthesia.

Exclusion criteria

Exclusion criteria: 1. contraindication to regional anaesthesia. 2. Major renal, hepatic or cardiovascular dysfunction. 3. known Psychiatric disorders like depression, schizophrenia, anxiety. 4. known allergy to Melatonin. 5. Pregnancy. 6. Language and communication difficulties. 7.Patients who refuse to participate in study.

Design outcomes

Primary

MeasureTime frame
Assess pre-operative Anxiety using STAI scale.Timepoint: 60-90 minutes prior to surgeries and just before shifting the patient to surgery. Then following up patients till 72 hours post-operatvely.—

Secondary

MeasureTime frame
1. pain using VAS in post operative period. 2.Time to request first analgesic. 3. total analgesic consumption of Paracetamol and Diclofenac sodium post-operatively. 4.peri-operative quality of sleep. 5.side effects, if any.Timepoint: upto 72 hours post-operatively.—

Countries

India

Contacts

Public ContactDr Lisa Barman

Pt. B.D. Sharma PGIMS, Rohtak

drshashi64@rediffmail.com9416763899

Outcome results

None listed

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