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Comparative study between oral melatonin and oral pregabalin on preoperative anxiety and perioperative sedation in surgeries under regional anaesthesia

Comparative study between oral melatonin and oral pregabalin on preoperative anxiety perioperative sedation and postoperative analgesia in surgeries under regional anaesthesia-A randomised control study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/08/020502
Enrollment
64
Registered
2019-08-01
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: R451- Restlessness and agitation

Interventions

Intervention1: preanaesthetic medication: T.Melatonin 6mg per oral,1hour prior to surgery Control Intervention1: preanaesthetic medication: T.Pregabalin 300mg per oral, 1hour prior to surgery

Sponsors

Chettinad Hospital and Research Institute
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: -American Society of Anaesthesiologists(ASA) grade I-II -BMI -patients scheduled for surgery under sub arachnoid block

Exclusion criteria

Exclusion criteria: -pregnant patients -mentally impaired patients,those with history of psychiatric orders,or on any antipsychotic drug intake,sleep disorders and inability to read and write basic alphabets and numbers were excluded from study

Design outcomes

Primary

MeasureTime frame
-Preoperative Anxiolysis Timepoint: -Before giving the study drug -1 hour after giving study drug—

Secondary

MeasureTime frame
Orientation ScoreTimepoint: -Before giving study drug -1 hour after giving study drug;Sedation ScoreTimepoint: -Before giving study drug -1 hour after giving study drug -During surgery(0 minute,5minutes,10minutes,15 minutes,20minutes,30minutes,40minutes,50minutes,60minutes,70minutes,80minutes,90minutes) -End of surgery;Time taken for first request for post operative analgesiaTimepoint: Time taken for first request for post operative analgesia;Time Taken for TMT A and BTimepoint: -Before giving study drug -1 hour after giving study drug—

Countries

India

Contacts

Public ContactIris Eapen

Chettinad Hospital and Research Institute

iris.eapen@gmail.com7299589410

Outcome results

None listed

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