Is There a Benefit to the Use of Melatonin in Preoperative Zygomatic Fractures?
Study Goal
The researchers aimed to evaluate the effects of melatonin on sleep quality, sedation, anxiolysis, opioid consumption, and extubation time in patients undergoing surgical treatment for zygomatic fractures.
Results Summary
Melatonin improved sleep quality the night before surgery and reduced intraoperative opioid consumption but did not enhance anxiolysis. It also increased the time required for safe endotracheal extubation compared to placebo.
Population
Patients undergoing surgical treatment for zygomatic fractures.
Effective Dosage
10 mg (one tablet the night before surgery and another 2 hours before surgery).
Duration
Short-term (preoperative period).
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
melatonin (10 mg) | increase | sleep quality the night before surgery | patients who had undergone surgical treatment of a zygomatic fracture | 61.1% reported better or much better sleep vs 100% reported worse or as usual in placebo | was effective in improving | #1 |
melatonin (10 mg) | no change | anxiolysis | patients who had undergone surgical treatment of a zygomatic fracture | P > .05 | was no better than placebo in relation to | #2 |
melatonin (10 mg) | decrease | intraoperative opioid consumption | patients who had undergone surgical treatment of a zygomatic fracture | 0.296 ± 0.036 μg/kg/min vs 0.372 ± 0.037 μg/kg/min in placebo | reducing | #3 |
melatonin (10 mg) | increase | time required for safe endotracheal extubation | patients who had undergone surgical treatment of a zygomatic fracture | 14.84 ± 1.8 minutes vs 12.72 ± 0.99 minutes in placebo | increase in | #4 |
PURPOSE: We evaluated the effects of melatonin used in the preoperative period for patients who had undergone surgical treatment of a zygomatic fracture. PATIENTS AND METHODS: A triple-blind, randomized clinical trial of 2 groups was conducted: the melatonin group (10 mg) and the placebo group. After allocation, 1 tablet of melatonin was used the night before and another tablet 2 hours before the start of surgery. Approximately 30 minutes before anesthetic induction, the following variables were evaluated: sleep quality, degree of sedation and anxiolysis using the Richmond Agitation-Sedation Scale, and the amount of opioid analgesic used intraoperatively. At the end of surgery, the time required for safe endotracheal extubation was evaluated. Next, a descriptive and inferential statistical analysis was performed. The margin of error considered was 5%. RESULTS: Of the 68 analyzed patients, 36 had been allocated to the melatonin group and 32 to the placebo group. In the sleep quality evaluation for the night before surgery, 61.1% of the melatonin group reported better or much better sleep than usual, and 100% of the placebo group reported worse sleep or sleep as usual (P < .001). Melatonin was no better than placebo in relation to anxiolysis (P > .05). The average final dose of the opioid was lower, and the difference was statistically significant, in the melatonin group (0.296 ± 0.036 μg/kg/min vs 0.372 ± 0.037 μg/kg/min in the placebo group). The interval required for safe endotracheal extubation was longer, and the difference was statistically significant, in the melatonin group (14.84 ± 1.8 minutes vs 12.72 ± 0.99 minutes in the placebo group). CONCLUSIONS: In the present study, melatonin was effective in improving sleep quality the night before surgery and in reducing intraoperative opioid consumption. An increase in the time required for safe endotracheal extubation was found in the melatonin group, and no improvement was seen in anxiolysis.