Compared to Intravenous Injection of Midazolam, Does Intranasal Dexmedetomidine Provide Adequate Sedation for...

Conscious sedation is crucial for managing anxiety and ensuring safety during dentoalveolar surgery. The efficacy of intranasal dexmedetomidine (DEX) as a sedative agent in this context remains unclear.

The purpose was to measure and compare the level of sedation in subjects receiving either intranasal DEX or intravenous midazolam (MID).

A randomized, nonblinded clinical trial was conducted at the People's Liberation Army 63750 Hospital. Patients scheduled for outpatient dentoalveolar surgery between February and April 2024 were screened. Those requiring vasoactive drugs during operation were excluded.

The primary intervention was the esthetic agent, and subjects were randomly assigned to receive either intranasal DEX (1.5 μg/kg) or intravenous MID (0.07 mg/kg).

The primary outcome was the Observer's Assessment of Alertness/Sedation scale (1 = deep sleep, 5 = fully alert; lower scores indicate deeper sedation). Measurement time points were when sedation was ready, when local anesthetic infiltration started, 5 minutes, 10 minutes, 15 minutes, 20 minutes, and 30 minutes during the intraoperative period, and 30 minutes after the completion of the operation. Secondary outcomes included visual analog scale, hemodynamic parameters, and adverse events.

The covariates included demographics (age, sex), perioperative variables (procedure type, medications for heart rate or hemodynamic blood pressure), and operative details (number of teeth, volume of local anesthetic, and surgical time).

Data were analyzed using independent samples t tests, χ² tests, and repeated measures analysis of variance (ANOVA) for the primary outcome. Statistical significance was set at P < .05.

The sample was composed of 103 subjects with a mean age of 63.98 ± 16.89 (P = .6) and 43 (42%) were male (P = .5). Observer's Assessment of Alertness/Sedation scores were 2.65 ± 0.481 and 2.30 ± 0.462 for MID and DEX, respectively (P < .001). Visual analog scale scores were 1.72 ± 1.180 and 1.27 ± 1.163 for MID and DEX, respectively (P = .037). Systolic pressure was 124.18 ± 8.4341 and 120.65 ± 9.180 for MID and DEX, respectively (P = .030). Diastolic pressure was 78.30 ± 5.475 and 76.28 ± 4.762 for MID and DEX, respectively (P = .033); heart rate was 74.98 ± 3.296 and 72.95 ± 5.047 for MID and DEX, respectively (P = .010). No significant differences were observed in oxygen saturation (P = .069) or adverse reactions (P = .5).

Compared to intravenous injection of MID, intranasal DEX was statistically significantly associated with superior early intraoperative sedation and safety.