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a clinical trial to study efficacy of two different doses of melatonin for anxiety alleviation in pre-operative patients

Comparison of two doses of melatonin for preoperative anxiolysis - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/08/072706
Enrollment
100
Registered
2024-08-19
Start date
Unknown
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

Health Condition 1: 3- Administration Health Condition 2: O- Medical and Surgical Health Condition 3: 8- Other Procedures Health Condition 4: 8- Other Procedures Health Condition 5: 8- Other Procedures

Interventions

Intervention1: Melatonin 3mg: Patints in group M3 will receive 3mg of oral melatonin 90 minutes before induction of general anaesthesia Control Intervention1: Melatonin 5mg: Patients of group M5 will

Sponsors

Dayanand Medical College and Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. ASA I & II 2. Patients posted for elective surgery under general anaesthesia

Exclusion criteria

Exclusion criteria: 1.ASA physical status III and IV 2.Patients with Trait Anxiety Score STAI-T more than 45 during preanaesthetic checkup 3.Patients with known allergy to melatonin 4.Obese patients BMI more than 30 kg/m2 5.Patients already taking sedatives, anti psychotics, anxiolytics, anti epileptics 6.Pregnant and lactating mothers 7.Patient’s refusal to participate in the study

Design outcomes

Primary

MeasureTime frame
STAI-S score at 90 minutes after drug administration in the two groups.Timepoint: 90 minutes

Secondary

MeasureTime frame
1.STAI-S score, at the time of preanaesthetic check-up and just before administration of the study drug with in each group. 2.NRS-A score at 90 minutes after drug administration in the two groups. 3.RSS score at 90 minutes after drug administration in the two groups. Timepoint: 90 minutes

Countries

India

Contacts

Public ContactDr Anshita Gupta

Dayanand Medical College and Hospital

anshitagupta97@gmail.com9501437656

Outcome results

None listed

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