Assessment of spontaneous neuromuscular recovery: A comparison of the TOF-Cuff® with the TOF Watch SX®.

BACKGROUND: TOF-Cuff® is a modified blood pressure cuff used to monitor neuromuscular block. We compared the assessment of spontaneous neuromuscular recovery between TOF-Cuff® (test device) and TOF Watch SX® (reference device). METHODS: Forty patients aged 18-65 years undergoing elective surgery were enrolled. TOF-Cuff® was installed on an upper arm and the TOF Watch SX® on the thumb of the opposite side. Anaesthesia was induced and maintained with intravenous propofol and sufentanil. After induction, the devices were calibrated and continuous train-of-four (TOF) stimulation was started. A single intravenous dose of rocuronium (0.6 mg kg-1 ) was administered for intubation. The primary outcome was total recovery time (time in minutes from the injection of rocuronium to a normalized TOF ratio of 90%). Agreement between the two devices was calculated using mean difference and limits of agreement. RESULTS: The primary outcome could be analysed in 27 patients because of 13 exclusions due to neuromuscular block reversal for shorter procedure surgical time, necessity of reinjection of rocuronium or technical failures of one of the two devices. Median total recovery time with the test device was 45 minutes (interquartile range [IQR] 38.5-61.5) and 63 minutes (IQR 51.1-74.5) with the reference device. Total recovery time with the test device was on average 16.4 minutes shorter (limits of agreement, -6.1 to 39); increasing total recovery time was associated with increasing difference. The TOF ratio of the reference device was on average 0.59 (SD 0.23) when the test device indicated complete recovery. The TOF ratio of the test device was on average 0.98 (SD 0.03) when the reference device indicated complete recovery. CONCLUSION: When compared with the TOF Watch SX® , TOF-Cuff® overestimates spontaneous recovery of a rocuronium-induced neuromuscular block.

Reporting of conflicts of interest and of sponsorship of guidelines in anaesthesiology. A cross-sectional study.

Guideline recommendations may be biased due to conflicts of interest (COI) of panel members and sponsorship of the guideline. Potential impact of COI, and their management, should be transparently reported. We analysed 110 guidelines published in ten anaesthesia journals from 2007 to June 2018. We report on the number (%) that 1) published COI disclosures; 2) in a distinct paragraph; 3) described and explained the COI of panel members, and 4) of the Chairperson; 5) reported and described the presence or absence and potential impact of a sponsor of the guideline on the recommendations; and 6) reported how COI were managed. COI were published in 70/110 (64%) guidelines; in a distinct paragraph in 25/70 (36%). Panel members reported having no COI in 27/70 (39%) guidelines, disclosed COI without describing their potential impact in 41/70 (59%), and described their potential impact in 2/70 (3%). Chairpersons were identified in 50 guidelines, 32 of which published COI disclosures; 16/32 (50%) reported having no COI, 14/32 (44%) disclosed COI without describing their potential impact, 1/32 (3%) described their impact and 1/32 (3%) made no statement regarding COI. Presence or absence of a sponsor of the guideline was reported in 40 guidelines; 12/40 (30%) declared none, 24/40 (60%) reported sponsoring without explanation of the potential impact, and 4/40 (10%) described the potential influence of the sponsor on the guideline recommendations. Seventy-five guidelines reported COI of panel members and/or sponsorship of the guideline but only seven described how the COI had been managed. Disclosures of COI of panel members and of sponsors of guidelines have increased over the 12 year period, but remain insufficiently described and their potential influence on the guidelines' recommendations is poorly documented.

Identification of ethics committees based on authors' disclosures: cross-sectional study of articles published in the European Journal of Anaesthesiology and a survey of ethics committees.

BACKGROUND: Since 2010, the European Journal of Anaesthesiology has required the reporting of five items concerning ethical approval in articles describing human research: ethics committee's name and address, chairperson's name, study's protocol number and approval date. We aimed to assess whether this requirement has helped to identify and to contact the referenced ethics committees. METHODS: In this cross-sectional study, we analysed articles requiring ethical approval, according to the Swiss federal law for human research and published in the European Journal of Anaesthesiology in 2011. Ethics committees were searched through our institutional Internet access based on information provided in the articles. The last search was performed in November 2015. Numbers (%) of items reported, of ethics committees identified, and of those that confirmed having provided ethical approval are reported. RESULTS: Of 76 articles requiring ethical approval, 74 (97%) declared it. Ethics committees' names and addresses were mentioned in 63/74 (85%), protocol numbers in 51/74 (69%), approval dates in 48/74 (65%), and chairpersons' names in 45/74 (61%). We could identify 44/74 (59%) committees; 36/74 (49%) answered our inquiry and 24/74 (32%) confirmed their role. Thirty-four of 74 articles (46%) reported all five items; in 25/34 (74%), we were able to identify an ethics committee, 18/34 (53%) answered our inquiry, and 15/34 (44%) confirmed their role. Forty of 74 articles (54%) reported ≤4 items; in 19/40 (48%), we were able to identify an ethics committee, 18/40 (45%) answered our inquiry, and 9/40 (23%) confirmed their role. Reporting five items significantly increased identification of ethics committees (p = 0.023) and their confirmation of ethical approval (p = 0.048). Twelve of 74 ethics committees (16%) were unable to confirm their role in approving the study. CONCLUSIONS: Even when details concerning ethical approval were reported in these studies of human research, we were unable to identify almost half of the ethics committees concerned. The reporting of five items, compared with reporting ≤4, was associated with facilitated identification of ethics committees, and increased the likelihood that they would be able to confirm the study's approval. Future research should identify which information facilitates identification of, and contact with, ethics committees.

A needle-free jet-injection system with lidocaine for peripheral intravenous cannula insertion: a randomized controlled trial with cost-effectiveness analysis.

UNLABELLED: Insertion of a peripheral IV cannula is a common, although painful, procedure. We tested the analgesic efficacy, adverse effects, and cost-effectiveness of a needle-free intradermal drug delivery system (Jet) with lidocaine for the insertion of an IV cannula (18-gauge; dorsum of hand). Four-hundred patients were randomly allocated to one of four groups: (a) no treatment, (b) Jet (J-Tip), National Medical Products Inc, CA; $3.0 per device) with 0.5 mL of saline, (3) Jet with 0.5 mL of lidocaine 1%, and (4) Jet with 0.5 mL of lidocaine 2%. Pain was evaluated using a numerical verbal scale (NVS 0-10). A NVS < or =3 was considered as acceptable in this context. Incremental cost-effectiveness ratios were calculated. Without treatment, 42.4% of patients had a NVS < or = 3, 39.3% with saline, 60.7% with 1% lidocaine (relative risk [RR] compared with no treatment, 0.70; 95% confidence interval [CI], 0.53-0.93), and 86.7% with 2% lidocaine (RR, 0.49; 95% CI, 0.38-0.62). Nineteen and one-half percent of patients had a NVS >3 because of Jet treatment, 13.5% had local hyperemia, and 16.9% had minor local bleeding. Of all Jet treatments, 10.5% were technical failures, and there were 17.6% cannula insertion failures (10.1% without treatment [RR, 1.74; 95% CI, 0.92-3.32]). Compared with no treatment, costs to generate one additional patient with a NVS < or =3 were $23 with lidocaine 1% and $10 with lidocaine 2%. On insertion of an IV cannula on the back of the hand, 58% of patients report at least moderate pain. Lidocaine-Jet is analgesic; there is dose-responsiveness. However, Jet treatment is not painless, and costs incurred to achieve one success compared with doing nothing are not negligible. IMPLICATIONS: Insertion of an IV cannula is painful. Four-hundred patients were randomly allocated to test the analgesic efficacy, adverse effects, and cost-effectiveness of the needle-free intradermal drug delivery system (J-Tip); Jet). Jet with lidocaine is effective, but its application is not painless. Costs to achieve one patient with no more than moderate pain (numerical verbal scale < or =3 of 10) on insertion of an IV cannula are $10.