Comparing use of melatonin with alprazolam in patient having surgery for breast cancer
Phase 3
- Conditions
- Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
- Registration Number
- CTRI/2022/06/043021
- Lead Sponsor
- Department of Anaesthesia and Intensive Care
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Anxiety as measured by State Trait Anxiety Inventory (STAI) , 90 minutes after morning dose of oral Melatonin / Alprazolam.Timepoint: 1.Night before surgery <br/ ><br>2.90 minutes after morning dose of the study drug
- Secondary Outcome Measures
Name Time Method 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 <br/ ><br>2.90 minutes after morning dose of the study drug <br/ ><br>3.6 hours after surgery <br/ ><br>4.24 hours after surgery