Premedication With Melatonin and Alprazolam Combination Versus Alprazolam or Melatonin Alone

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Background: Benzodiazepine, a common premedicant, suppresses endogenous melatonin levels and thus paradoxically increases episodes of arousal during sleep and thus causes restlessness and hangs over effects. Adding melatonin to it may decrease nocturnal arousal and promote the perception of sound sleep in the perioperative period.

Methods: Eighty patients (ASA 1&2) with anxiety VAS ≥ 2 posted for general anaesthesia will be randomly assigned to receive 0.5 mg alprazolam (Group A), 3 mg melatonin, a combination of 0.5 mg alprazolam and 3 mg melatonin (Group AM), or a similar looking placebo (Group P), approximately 90 minutes before surgery.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: B.P. Koirala Institute of Health Sciences
• Treatments: Alprazolam; Azaperone; Melatonin

Criteria

Inclusion Criteria:

• (ASA 1&2),

• aging 18 to 65 years

• having anxiety VAS score of more than 2

• posted for general anaesthesia with estimated duration of < 3 hours.

Exclusion Criteria:

• patients taking analgesics, sedatives, antiepileptics or antidepressants,

• suffering from obesity (BMI ≥ 28) or neuropsychiatric disease,

• having allergy to the study drugs