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JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL

The effect of the assignment of a pre-sedation target level on procedural sedation using propofol

James R Miner, Darren Huber, Scott Nichols, Michelle Biros
Journal of Emergency Medicine 2007, 32 (3): 249-55
17394986
The goal of this study was to determine if there is a difference in the achieved depth of sedation, the rate of respiratory depression, procedural difficulty, or patient perceived pain or recall between patients randomized to a pre-procedural target sedation level of moderate or deep procedural sedation using propofol during the reduction of fractures and dislocations in the Emergency Department (ED). This was a randomized, prospective study of adults undergoing procedural sedation (PS) with propofol for fracture or dislocation reduction in the ED between July 2003 and March 2004. Patients were randomized to a target sedation level of moderate or deep, using American Society of Anesthesiologists' definitions. Doses, vital signs, nasal end tidal CO(2) (ETCO(2)), pulse oximetry, and bispectral EEG analysis (BIS) scores were recorded. Respiratory depression was defined as a change in ETCO(2) >10, an oxygen saturation of <90% at any time, or an absent ETCO(2) waveform at any time. After the procedure, patients were asked if they perceived any pain or had any recall of the procedure. Physicians were asked to rate the difficulty of completing the reduction using a 100-mm visual analog scale (VAS). Respiratory depression rates were compared with chi-square tests, BIS and VAS scores were compared with t tests. Seventy-five patients were enrolled, 39 randomized to the target of moderate PS and 36 to the target of deep PS. No significant complications were noted. There were 25/36 (69%) of the patients assigned to the deep sedation target group who actually achieved a deep level of sedation and 21/39 (54%) of the patients assigned to the moderate sedation target group who actually achieved a moderate level of sedation (p = 0.40). Respiratory depression was seen in 19/39 (49%) patients with the moderate PS target and 18/36 (50%) with the deep PS target (p = 0.91). The mean minimum recorded BIS score was 67.7 (95% confidence interval [CI] 62.2-73.3) for the moderate PS target group and 59.2 (95% CI 55.1-64.2) for the deep PS target group (p = 0.03). There were 12/39 (31%) in the moderate PS target group and 4/36 (11%) in the deep PS target group who reported pain with or recall of the procedure (p = 0.04). The mean physician VAS for procedural difficulty was 34.0 (95% CI 23.7-44.3) for the moderate PS group and 28.8 (95% CI 18.4-39.2) for the deep PS group (p = 0.46). In this study, the assignment of a pre-procedural target sedation level of moderate or deep PS did not influence the level of sedation achieved, the rate of respiratory depression, the occurrence of complications, the time to return of baseline mental status, or the success of the procedure. It does not seem that the assignment of a pre-procedural target sedation level is an effective means of changing the outcome of ED PS.

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