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Objective <p>Orthognathic surgery is a complex maxillofacial procedure designed to correct skeletal jaw deformities, improving both functional and aesthetic outcomes. Despite its efficacy, the procedure carries risks of postoperative complications, including agitation, shivering, nausea, and intraoperative recall. Midazolam, a short-acting benzodiazepine with anxiolytic and amnestic properties, is frequently used as a premedication. This study aims to evaluate the effect of midazolam on postoperative recovery outcomes in patients undergoing orthognathic surgery.</p> Methods <p>In this double-blind randomized clinical trial, 56 healthy patients scheduled for orthognathic surgery were enrolled. The participants were assigned to receive either intravenous midazolam (0.1 mg/kg) or a normal saline placebo at the onset of anesthesia induction. A standardized anesthesia protocol using propofol and remifentanil was maintained for all patients. The measured outcomes included the incidence and severity of postoperative agitation, shivering, nausea, and surgical recall. Also, intraoperative blood loss, recovery duration, and ICU admission rates were evaluated. Statistical analysis was performed using Mann–Whitney U, Independent T-tests, and Chi-square tests as appropriate (<i>P</i> &lt; 0.05).</p> Results <p>The two groups were comparable regarding demographic data, ASA classification, and surgical duration (<i>p</i> &gt; 0.05). No significant differences were found in median intraoperative blood loss (350 mL in the midazolam group vs. 300 mL in the control group; <i>p</i> = 0.190) or median recovery duration (60 min for both groups; <i>P</i> = 0.204). Although the midazolam group showed lower frequencies of agitation, shivering, and nausea, these differences did not reach statistical significance (<i>P</i> &gt; 0.05). Surgical recall was reported in 3.6% of the midazolam group compared to 10.7% in the control group (<i>P</i> &gt; 0.05). No adverse pharmacological events or significant respiratory depressions were recorded in either cohort.</p> Conclusion <p>Pre-induction administration of IV midazolam did not decrease the incidence of postoperative complications such as agitation, shivering, or nausea.</p>

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Effect of IV midazolam premedication before anesthesia on post-recovery outcomes in orthognathic surgery: a double blind randomized clinical trial

  • 期刊论文

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  • 发表日期：

    2026年5月12日

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  • Ali Modaberi,
  • Hamidreza Eftekharian,
  • Hosein Askari,
  • Nasim Morshedian,
  • Sheila Shahsavari-Pour

摘要

Objective

Orthognathic surgery is a complex maxillofacial procedure designed to correct skeletal jaw deformities, improving both functional and aesthetic outcomes. Despite its efficacy, the procedure carries risks of postoperative complications, including agitation, shivering, nausea, and intraoperative recall. Midazolam, a short-acting benzodiazepine with anxiolytic and amnestic properties, is frequently used as a premedication. This study aims to evaluate the effect of midazolam on postoperative recovery outcomes in patients undergoing orthognathic surgery.

Methods

In this double-blind randomized clinical trial, 56 healthy patients scheduled for orthognathic surgery were enrolled. The participants were assigned to receive either intravenous midazolam (0.1 mg/kg) or a normal saline placebo at the onset of anesthesia induction. A standardized anesthesia protocol using propofol and remifentanil was maintained for all patients. The measured outcomes included the incidence and severity of postoperative agitation, shivering, nausea, and surgical recall. Also, intraoperative blood loss, recovery duration, and ICU admission rates were evaluated. Statistical analysis was performed using Mann–Whitney U, Independent T-tests, and Chi-square tests as appropriate (P < 0.05).

Results

The two groups were comparable regarding demographic data, ASA classification, and surgical duration (p > 0.05). No significant differences were found in median intraoperative blood loss (350 mL in the midazolam group vs. 300 mL in the control group; p = 0.190) or median recovery duration (60 min for both groups; P = 0.204). Although the midazolam group showed lower frequencies of agitation, shivering, and nausea, these differences did not reach statistical significance (P > 0.05). Surgical recall was reported in 3.6% of the midazolam group compared to 10.7% in the control group (P > 0.05). No adverse pharmacological events or significant respiratory depressions were recorded in either cohort.

Conclusion

Pre-induction administration of IV midazolam did not decrease the incidence of postoperative complications such as agitation, shivering, or nausea.