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Comparison of melatonin versus gabapentin on post operative pain and anxiety in breast cancer surgery

Comparative study of melatonin versus gabapentin on post operative pain and anxiety in breast cancer surgery: A prospective comparative study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/02/031072
Enrollment
80
Registered
2021-02-08
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: C50- Malignant neoplasm of breast

Interventions

Intervention1: Administration of Melatonin: 6mg of Melatonin to group M orally 120 minutes before induction of anaesthesia Control Intervention1: Administration of Gabapentin: 600mg of Gabapentin to g

Sponsors

Kanika Bansal
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients giving written informed consent 2. Womwen of age group 20-60 years 3. ASA Grade I,II,III

Exclusion criteria

Exclusion criteria: Negative consent ASA IV Pregnancy History of confusion/ dementia/ communication difficulty Chronic use of narcotics/ barbiturates/ psychotropic medication Allergy to any of the drug to be used

Design outcomes

Primary

MeasureTime frame
1. Post operative pain intensity by VAS (Visual Analog Scale),Total analgesic requirement in first 24 hours, time of requirement of first rescue analgesia 2. Anxiety (verbal anxiety score) Timepoint: 1. Post operative pain intensity at 0, 1, 2, 6, 12, 24 hours after arrival in the recovery room, total analgesic requirement in first 24 hours, time of requirement of first rescue analgesia 2. Anxiety level is assessed at time of drug administration, just before induction of anaesthesia preoperatively and postoperatively at 0, 1, 2, 6, 12, 24 hours after arrival in the recovery room

Secondary

MeasureTime frame
1.Sedation level using Ramsay Sedation Scale 2. Effect on sleep using sleep quality index 3. Post operative cognitive dysfunction using MMSE scaleTimepoint: 1. Sedation level is assessed at 0,1,2,6,12,24 hours postoperatively 2.Sleep quality is assessed on day 1,2,3 postoperatively 3. Post operative cognitive dysfunction is assessed on day1, day3, 1week, 3week postoperatively

Countries

India

Contacts

Public ContactDr Jyotsna Agrawal

King George Medical University, Lucknow

dr.jyotsna@yahoo.co.in9415518399

Outcome results

None listed

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