Skip to content

Comparison of effects of oral melatonin and alprazolam as preoperative medicine and their effects on post operative recovery in patients undergoing ear surgery

Comparative evaluation of effects of oral melatonin and oral alprazolam as premedication and their effects on post operative recovery characteristics in patients undergoing tympanoplasty

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/08/044912
Enrollment
70
Registered
2022-08-25
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: O- Medical and Surgical

Interventions

Intervention1: Melatonin: Tab Melatonin 6mg to be given orally to patients 2 hours prior to surgery Control Intervention1: Alprazolam: Tab Alprazolam 0.5mg to be given orally to patients 2 hours prio

Sponsors

Sharda Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patient undergoing tympanoplasty surgeries under general anaesthesia 2. ASA class I and II

Exclusion criteria

Exclusion criteria: 1. Patient refusal to participate in the study 2. Patients receiving steroids, analgesics, antiemetic, sedatives and antipsychotics. 3. Patients having history of endocrine, cardiovascular, renal or CNS disease. 4. Patients allergic to study drugs. 5. BMI > 30 kg m-2 6. Patient having chronic pain and any mental illness 7. Pregnant patients 8. Patients with inability to read and write basic alphabets and numbers

Design outcomes

Primary

MeasureTime frame
To compare the effects of melatonin and alprazolam on preoperative anxiety.Timepoint: 2 hours post surgery

Secondary

MeasureTime frame
1. To compare the effects of melatonin and alprazolam on: (a) Pre-operative sedation (b) Pre-operative cognition 2. To compare the effects of melatonin and alprazolam on: (a) Post-operative sedation (b) Post-operative anxiety (c) Post-operative cognition 3. To compare post operative pain in the two groupsTimepoint: 2 hours post surgery

Countries

India

Contacts

Public ContactDr Harsh Vardhan

School of Medical Science and Research

harsh.vardhan1@sharda.ac.in

Outcome results

None listed

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