At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Premedication With Melatonin and Alprazolam Combination Versus Alprazolam or Melatonin Alone: a Randomized, Double Blind Placebo Controlled Study
In Brief
A Phase 4 clinical trial evaluating meloset (melatonin), stresnil ( melatonin and alprazolam), and 2 other interventions for Anxiety. Completed, enrolled 80 participants across 2 sites.
Detailed 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.
Study Details
Timeline
Interventions
3 mg melatonin tablet 1-2 hour prior surgery
3 mg melatonin and 0.5 mg alprazolam 1-2 hr before anesthesia
0.5 mg alprazolam
similar looking placebo tablet