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Comparison between effect two drugs on preoperative anxiety and post operative sedation in adult patient undergoing operation with General Anaesthesia

Effect of premedication with melatonin and midazolam on anxiety score and sedation:a randomised control trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/06/112649
Enrollment
50
Registered
2026-06-12
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-22

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

Control Intervention1: Tab Melatonin: Melatonin is a natural ocurring sleep inducer and also an anxiolytic. This study is done to compare the sedation and anxiolytic property of two drug Melatonin and

Sponsors

Departmentr of Anaesthesiology,IPGMER,Kolklata
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 ASA grade 1 and 2 2 age between 18 years to 65 years 3 written consent 4 Patient undergoing under general anaesthesia

Exclusion criteria

Exclusion criteria: 1 Allergic to Drugs being used for trials 2 Heart Disease, Respiratory illness(Asthma,Copd) 3 Terminally ill patient

Design outcomes

Primary

MeasureTime frame
1 Assesment of Anxiety level of a patient before and after surgery by anxiety score via VAS Scale and ASSQ 2 ASSESment of Sedation level of a patient before and after surgery by Seadtion Scale via Ramsay Sedation ScoreTimepoint: 1 Assesment of Anxiety level of a patient before and after surgery by anxiety score via VAS Scale and ASSQ at 45 minutes after premedication, after entering at operation theatre and also in PACU at 30, 60, 90, 120 minutes 2 ASSESment of Sedation level of a patient before and after surgery by Seadtion Scale via Ramsay Sedation Score 45 minutes after premedication and in PACU at 30,60,90,120 minutes

Secondary

MeasureTime frame
1 Hemodynamic Stability: Change in Heart Rate & mean arterial pressure from baseline to pre induction & after recoveryTimepoint: On arrival then after recovery in PACU at every 15 minutes interval for 2 hours e.g. 15 ,30,45,60 ,90,120 minutes

Countries

India

Contacts

Public ContactDr SHARMILA GHOSH

Institute of Post Graduate medical Education and Research

sghoshblg13@gmail.com7439131164

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026