A randomized controlled trial of light versus deep propofol sedation for elective outpatient colonoscopy: recall, procedural conditions, and recovery

Abstract

A randomized controlled trial of light versus deep propofol sedation for elective outpatient colonoscopy: recall, procedural conditions, and recovery Une étude randomisée contrôlée sur la sédation légère vs profonde au propofol pour la colonoscopie non urgente en ambulatoire: le souvenir, les conditions entourant l'intervention et la récupération sedation; P \ 0.0001). The incidence of recall was 12% in the light sedation group and 1% in the deep sedation group. The risk difference for recall was 0.11 (90% confidence interval, 0.05 to 0.17) in the intention-to-treat analysis, thus refuting equivalence in recall between light and deep sedation (0.05 significance level; 10% equivalence margin). Overall sedation-related complications were more frequent with deep sedation than with light sedation (66% vs 47%, respectively; P = 0.008). Recovery was more rapid with light sedation than with deep sedation as determined by the mean (SD) time to reach a score of 5 on the Modified Observer's Assessment of Alertness/Sedation Scale [3 (4) min vs 7 (4) min, respectively; P \ 0.001] and by the median [IQR] time to min, respectivement; P = 0.001). L'incidence des troubles cognitifs post-procéduraux était semblable chez les personnes randomisées à recevoir une sédation légère (19 %) ou profonde (16 %) (P = 0,554). Conclusion La sédation légère n'était pas équivalente à la sédation profonde en matière de souvenir de l'intervention, du spectre de complications ou des temps de récupération. Cette étude procure des données probantes nécessaires pour informer les patients concernant la sédation pour la colonoscopie. Cette étude a été enregistrée au Registre australien et néozélandais des études cliniques, no. 12611000320954.

Safety of sedation for gastrointestinal endoscopy in a group of university-affiliated hospitals: a prospective cohort study

“…Emergency patients suffered more intra-operative significant unplanned events (20.6% vs 14.4%; P ¼ 0.003) and 30-day mortality (6.0% vs 0.2%; P <0.0001) than elective patients. Time to death was not significantly different in elective and emergency patients who died (13 [0-28] days in emergency patients vs 11 [10][11][12][13][14][15][16][17][18] days in elective patients; P ¼ 0.49).…”

“…Events with a frequency of nine or more (0.3%) would have 95% confidence intervals (CI) where the lower limit was greater than 0.1%. 13 Based on published results 14 and our recent trial, 15 this sample size was thought to be sufficient for robust estimates of most intra-procedure events.…”

A randomized-controlled trial of high- or low-volume intravenous Plasma-Lyte® to prevent hypotension during sedation for colonoscopy

“…These observations are consistent with studies using similar sedation regimens. 22 We did not identify significant modifiable predictors of hypotension in this study. While we found that lower VAS scores for thirst after infusion were associated with greater odds of hypotension, given the multiple factors tested, this could be a random relationship.…”

Optimizing depth of sedation for colonoscopy

“…5 Depth of sedation was measured using the bispectral electroencephalographic (EEG) index (i.e., bispectral index [BIS]) aimed at a BIS value of 70-80 or \ 60 for ''light'' and ''deep'' sedation, respectively. The primary outcome was unintentional recall of the procedure.…”

“…rapportent un essai randomisé d'équivalence comparant la sédation profonde à la sédation légère en utilisant une perfusion de propofol à concentration cible chez 199 patients ambulatoires subissant une colonoscopie. 5 La profondeur de la sédation a été mesurée au moyen d'un indice encéphalographique (EEG) bispectral (c'est-à-dire, l'indice bispectral [BIS]) visant une valeur de 70 à 80 ou\ 60 pour, respectivement, une sédation « légère » ou une sédation « profonde ». Le critère d'évaluation principal était la mémoire involontaire de la procédure.…”