Propofolversuscombined sedation in flexible bronchoscopy: a randomised non-inferiority trial

Abstract

Combined sedation with a benzodiazepine and an opiate has been proposed as standard sedation for bronchoscopy. Propofol is a sedative-hypnotic with a rapid onset of action and fast recovery time, but carries the potential risk of respiratory failure.Consecutive patients (n5200) were randomly allocated to receive either the combination midazolam and hydrocodone or intravenous propofol. The primary end-points were the mean lowest arterial oxygen saturation during bronchoscopy and the readiness-for-discharge score 1 h after the procedure.The mean lowest arterial oxygen saturation during bronchoscopy did not differ across treatment groups (p50.422), and the number of patients recording an arterial oxygen saturation of f90% on at least one occasion was similar in both groups (p50.273). The median (interquartile range) readiness-for-discharge score 1 h after the procedure was significantly higher in the propofol group than in the combined sedation group (8 (6-9) versus 7 (5-9); p50.035). Patients assigned propofol exhibited less tachycardia during bronchoscopy and for o1 h after the examination. Minor procedural complications were noted in 71 (35.5%) patients and exhibited a similar incidence in both treatment arms (p50.460).Propofol is as effective and safe as combined sedation in patients undergoing flexible bronchoscopy, thus representing an appealing option if timely discharge is a priority.

Propofolversuspropofol plus hydrocodone for flexible bronchoscopy: a randomised study

“…Assuming a mean cough score of 4.35 in the arm treated with propofol alone and a score of 3.35 in the arm treated with combined sedation, each of them with a standard deviation of 1.5 [11], a total of 286 patients, 143 in each treatment arm, would be needed to achieve a significance level of p,0.05 with a power of 0.9. Considering a 5% loss to follow-up, a total of 300 patients were predicted for inclusion.…”

“…This is particularly interesting in view of the low cough scores reported in both treatment arms, as one could hypothesise that the reduction in procedure time could be caused by the coughing suppressing effect of hydrocodone. In combination with the fact that propofol allows earlier discharge compared with a regimen including midazolam and hydrocodone [11], the potential additional time-saving during the examination might represent a further argument to support sedation with propofol and hydrocodone, particularly in complex examinations. Similar findings have been recently reported for endoscopic procedures of the gastrointestinal tract.…”

“…Its pharmacological mechanism is not entirely clear yet, however, it seems to activate the caminobutyric A receptor-chloride ionophore complex [16]. Its rapid onset of action and amnesic properties, coupled with smooth and rapid recovery, make propofol an appealing agent for procedural sedation [11,17,18]. The significant advantage of a faster recovery time compared with other sedatives has been emphasised in several studies [19][20][21][22].…”

“…Additionally, propofol seems to provide a higher quality of sedation in terms of neuropsychometric recovery and patient tolerance [14]. There is mounting evidence to suggest that this sedation technique can be safely performed by the nonanaesthesiologist [11,14].…”

“…In spite of the recommendations of the British Thoracic Society guidelines [1], combined sedation with opiate and a benzodiazepine has been shown to be effective and safe in a randomised, placebo-controlled trial, even in high-risk patients, such as those suffering from chronic obstructive pulmonary disease (COPD) [10]. Recently, propofol (2,6 diisopropylphenol) proved to be an attractive option to combined sedation with midazolam and hydrocodone, particularly if timely discharge is a priority [11][12][13]. Additionally, propofol seems to provide a higher quality of sedation in terms of neuropsychometric recovery and patient tolerance [14].…”