Research paper
Premedication with Oral Alprazolam and Melatonin Combination: A Comparison with Either Alone—A Randomized Controlled Factorial Trial
Study answer
What this study found
The alprazolam plus melatonin combination was more effective for preoperative anxiolysis than either agent alone or placebo. At 60 minutes, anxiety reduction from baseline in the combination arm was 3 (1.0-4.3) cm versus 0 (0-1.7) cm with placebo (P = 0.008). Sedation at 60 minutes was also greater with the combination than placebo, 1 (1.0-1.75) versus 0 (0-1) (P = 0.008), and greater than melatonin alone, 1 (1.0-1.75) versus 0.5 (0-1) (P = 0.001). Amnesia for the picture task at 60 minutes favored the combination and alprazolam alone over melatonin and placebo, and 19 of 20 participants in…
- Study & population
- Randomized controlled factorial trial with four parallel groups in adults 18 to 65 years old, ASA I-II, with preoperative anxiety (VAS score >=3) undergoing elective laparoscopic cholecystectomy.
- Intervention
- Oral premedication given 90 minutes before surgery.
- Key limitation
- Small per-arm sample size and short perioperative follow-up limit precision and longer-term interpretation.
Original abstract
We assessed if the addition of melatonin to alprazolam has superior premedication effects compared to either drug alone. A prospective, double blind placebo controlled trial randomly assigned 80 adult patients (ASA 1&2) with a Visual Analogue Score (…