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Comparing use of melatonin with alprazolam in patient having surgery for breast cancer

Melatonin versus Alprazolam as a Premedicant in Breast Cancer Surgeries: A Randomized, Double-Blind Clinical Trial

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/06/043021
Enrollment
60
Registered
2022-06-06
Start date
Unknown
Completion date
Unknown
Last updated
2022-06-27

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

Conditions

Health Condition 1: C509- Malignant neoplasm of breast of unspecified site

Interventions

Intervention1: melatonin: 3mg+3mg of melatonin to be given to check th effect on perioperative anxiety Control Intervention1: alprazolam: 0.25 mg + 0.25 mg of alprozolam to be given to check the effec

Sponsors

Department of Anaesthesia and Intensive Care
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adult females of ASA physical status 1 & II, between the age group of 18-60 years scheduled to undergo breast cancer surgery under general anaesthesia

Exclusion criteria

Exclusion criteria: Patients which are- 1. Above 60 years of age 2. ASA III and IV 3. Have a history of any neuropsychiatric illness 4. Already on antiepileptic ,antipsychotic and anticholenergic drugs • With uncontrolled HTN, diabetes or thyroid disorders. • Unable to read or write • Unable to understand the scoring systems used in the study • With history of any allergy to study drugs • Refusal to give consent

Design outcomes

Primary

MeasureTime frame
Anxiety as measured by State Trait Anxiety Inventory (STAI) , 90 minutes after morning dose of oral Melatonin / Alprazolam.Timepoint: 1.Night before surgery 2.90 minutes after morning dose of the study drug

Secondary

MeasureTime frame
Baseline Anxiety, anxiety levels 6 hours after surgery, Cognitive Functions (DSST), VAS Sleep score , sedation score (MOASS) , Orientation and any adverse effect.Timepoint: 1.Night before surgery 2.90 minutes after morning dose of the study drug 3.6 hours after surgery 4.24 hours after surgery

Countries

India

Contacts

Public Contactpulkit bansal

post graduate institute of medical education and research

drsumanarora@hotmail.com7087009528

Outcome results

None listed

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