A clinical trial to study the effects of pre operative tablet melatonin in patients undergoing infra umbilical surgeries under spinal anaesthesia.
Completed
- Conditions
- Unspecified abdominal hernia withobstruction, without gangrene,
- Registration Number
- CTRI/2018/08/015192
- Lead Sponsor
- Sagar Srinivas K
- Brief Summary
This is a randomized, double blind, parallel group trial comparing the efficacy of preoperative oral melatonin 3mg on postoperative pain in patients undergoing infra-umbilical surgeries under subarachnoid block. It will be conducted in VIctoria hospital, Bangalore. The primary outcome measure is post-operative pain in first 24 hours. The secondary outcomes are to assess the peri-operative sedation and anxiolytic effects of oral melatonin 3mg.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria
- Patients who have given written informed consent.
- Patients with ASA grade I & II.
- Patients scheduled for elective infra-umbilical surgeries under subarachnoid block.
Exclusion Criteria
- Patients refusing to participate in the study.
- Patients with history of psychiatric disorders on antipsychotic drugs.
- Patients with history of sleep disorders.
- Patients on anticoagulants.
- Patients with hypertension, type2 DM, IHD.
- Pregnant women.
- Contraindication to spinal anaesthesia.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Postoperative pain measured using VAS score Postoperative 24 hours
- Secondary Outcome Measures
Name Time Method Anxiety measured using HAM-A scale Peri-operatively upto 24 hours after surgery
Trial Locations
- Locations (1)
Victoria Hospital
🇮🇳Bangalore, KARNATAKA, India
Victoria Hospital🇮🇳Bangalore, KARNATAKA, IndiaSagar Srinivas KPrincipal investigator9844265261sagarsrinivas91@gmail.com