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15 result(s) for "Laferrière-Langlois, Pascal"
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Virtual reality as a strategy for intra-operatory anxiolysis and pharmacological sparing in patients undergoing breast surgeries: The V-RAPS randomized controlled trial protocol
Virtual reality (VR) has increasingly found applications beyond leisure and video games, extending into the field of medicine. Recent studies indicate that VR can effectively reduce anxiety and pain in pediatric patients undergoing uncomfortable medical procedures, such as burn wound care. Yet, VR use in the operating room is still rare, despite a growing trend toward regional anesthesia without general anesthesia; physicians still frequently rely on pharmacological sedation to manage procedural anxiety. By leveraging VR's anxiolytic properties, it may be possible to decrease the need for intravenous (IV) sedation which is associated with risk of adverse events like apnea and hypoxemia and delayed recovery. This study's main objective is to determine the impact of VR on IV sedation requirements in adult patients undergoing breast surgery under paravertebral (PV) block without general anesthesia. We will be using Paperplane Therapeutics' VR headset and software which offer three distinct VR scenario choices. We hypothesize that VR immersion will reduce the need for intraoperative pharmacological sedation. Secondary objectives include assessing the tolerance of patients to the VR headset, examining the impact of the chosen VR scenario on the primary outcome, evaluating the incidence of adverse effects, measuring patient satisfaction, and analyzing the output of the Nociception Level (NOL) Index among awake surgical patients. This single center randomized controlled trial will enroll 100 patients aged 18 or above undergoing breast surgery under PV block. Participants will be randomly allocated to the VR group or the control group; both will have access to pharmacological sedation through patient-controlled sedation (PCS). Participants in the VR group will choose between three different VR scenarios and will be allowed to switch between these scenarios during surgery. The primary outcome will be the time-adjusted and weight adjusted dose of self-administered intraoperative propofol. Secondary outcomes will include patient satisfaction, adverse events, and post-anesthesia care unit length of stay (PACU LOS). This trial has been approved by the regional ethics committee (Comité d'Éthique de la Recherche du CIUSSS de l'Est de l'Île de Montréal) on September 9th, 2024. ClinicalTrials.gov (July 25th, 2024). Unique protocol ID: 2025-3802. Trial identification number: NCT06522711.
Low dose of sugammadex versus neostigmine for reversal of rocuronium induced moderate neuromuscular block: a randomized controlled trial
Background Residual neuromuscular blockade (rNMB) after surgery can lead to complications such as respiratory distress, increased length of hospital stay, and higher healthcare costs. Sugammadex, a selective relaxant-binding agent, has shown efficacy in reversing rocuronium-induced neuromuscular blockade more rapidly than neostigmine. This study aimed to evaluate the effectiveness of a low dose of sugammadex (0.5 mg.kg −1 ) compared to standard neostigmine with glycopyrrolate for the reversal of moderate rocuronium-induced neuromuscular blockade. Methods This randomized, double-blind, controlled trial included adult patients undergoing surgery with rocuronium-induced moderate neuromuscular blockade. Participants were randomized to receive either low-dose sugammadex or standard-dose neostigmine with glycopyrrolate at the end of surgery. The primary outcome was the time to achieve a Train-of-Four (TOF) ratio of ≥ 0.9 after administration of the reversal agent. Secondary outcomes included extubation time, incidence of sugammadex rescue therapy for incomplete reversal, and postoperative complications. Statistical analysis used t-tests and Mann–Whitney-Wilcoxon tests for continuous variables and chi-square tests for categorical variables, with significance set at p  < 0.05. Results The median time to reach TOF ratio of ≥ 0.9 was significantly shorter in the sugammadex group (4.3 min, IQR: 3.2–6) compared to the neostigmine group (20.6 min, IQR: 10.1–21.3, p  < 0.001). Extubation times were also reduced with sugammadex, with a median of 11.6 (IQR: 8.6–15.1) minutes versus 25.9 (IQR: 17.7–29.7) minutes in the neostigmine group ( p  < 0.001). Only 4.8% of patients in the sugammadex group required rescue therapy to reverse the neuromuscular block with TOF ratio of ≥ 0.9, compared to 60.6% in the neostigmine group ( p  < 0.001). No significant differences were observed in postoperative respiratory complications or PACU length of stay. Conclusions Low-dose sugammadex provides a faster and more reliable reversal of moderate neuromuscular blockade than standard-dose neostigmine, with implications for improved operating room efficiency and patient safety. Continuous neuromuscular monitoring remains essential, as a small proportion of patients may still require additional intervention. Trial registration Registered retrospectively at ClinicalTrials.gov with registration number NCT05718934 on 2023–02-08.
A novel AI-guided and motorized videolaryngoscope aiming to democratize endotracheal intubation
Videolaryngoscopy has improved glottic visualization during intubation, but difficulties in tube advancement and hand-eye coordination continue to limit procedural efficiency. These ergonomic challenges contribute to failed intubations even when visualization is adequate. The present study evaluated a novel artificial intelligence guided and motorized videolaryngoscope (AI-VL) designed to reduce manual dexterity demands and operator workload. A preclinical validation was conducted using 5 Thiel-embalmed cadavers. Three operators with varying airway experience performed 30 intubations using the AI-VL. Primary outcomes were first-attempt success rate, intubation time, and visible airway trauma. Secondary outcomes included operator workload using the weighted NASA task load index (NASA-TLX) and post-procedural usability Likert questionnaire. First-attempt success was 100% across all procedures, with a median intubation time of 14.3 s (IQR 11.0-22.8) and no visible tissue injury. The weighted NASA-TLX global workload was 29.1 ± 6.7 (0-100 scale), below the 25th percentile of published medical task norms, indicating low to moderate perceived demand. Mean usability ratings were 4.3 ± 0.6 on 5, with the highest scores for likelihood of clinical adoption and training suitability, 4.7 ± 0.6 and 5.0 ± 0.0 respectively. In this cadaveric study, the AI-VL preliminarily demonstrated consistent procedural success, short intubation times, relatively low operator workload, and high usability scores. These findings support its potential as a next generation videolaryngoscope and indicates the need for further clinical trials to explore its effectiveness across diverse clinical settings.
Effect of electroencephalography-guided anesthesia on neurocognitive disorders in elderly patients undergoing major non-cardiac surgery: A trial protocol The POEGEA trial (POncd Elderly GEneral Anesthesia)
The number of elderly patients undergoing major surgery is rapidly increasing. They are particularly at risk of developing postoperative neurocognitive disorders (NCD). Earlier studies suggested that processed electroencephalographic (EEG) monitors may reduce the incidence of postoperative NCD. However, none of these studies controlled for intraoperative nociception levels or personalized blood pressure targets. Their results remain unclear if the reduction in the incidence of postoperative NCD relates to avoidance of any electroencephalographic pattern suggesting excessive anesthesia depth. The objective of this trial is to investigate-in patients ≥ 70 years old undergoing major non-cardiac surgery-the effect of EEG-guided anesthesia on postoperative NCD while controlling for intraoperative nociception, personalized blood pressure targets, and using detailed information provided by the EEG monitor (including burst suppression ratio, density spectral array, and raw EEG waveform). This prospective, randomized, controlled trial will be conducted in a single Canadian university hospital. Patients ≥ 70 years old undergoing elective major non-cardiac surgery will be included in the trial. The administration of sevoflurane will be adjusted to maintain a BIS index value between 40 and 60, to keep a Suppression Ratio (SR) at 0%, to keep a direct EEG display without any suppression time and a spectrogram with most of the EEG wave frequency within the alpha, theta, and delta frequencies in the EEG-guided group. In the control group, sevoflurane will be administered to achieve an age-adjusted minimum alveolar concentration of [0.8-1.2]. In both groups, a nociception monitor will guide intraoperative opioid administration, individual blood pressure targets will be used, and cerebral oximetry used to tailor intraoperative hemodynamic management. The primary endpoint will be the incidence of NCD at postoperative day 1, as evaluated by the Montreal Cognitive Assessment (MoCA). Secondary endpoints will include the incidence of postoperative NCD at different time points and the evaluation of cognitive trajectories up to 90 days after surgery among EEG-guided and control groups. NCT04825847 on ClinicalTrials.gov.
Retroclavicular vs Infraclavicular block for brachial plexus anesthesia: a multi-centric randomized trial
Background The coracoid approach is a simple method to perform ultrasound-guided brachial plexus regional anesthesia (RA) but its simplicity is counterbalanced by a difficult needle visualization. We hypothesized that the retroclavicular (RCB) approach is not longer to perform when compared to the coracoid (ICB) approach, and improves needle visualization. Methods This randomized, controlled, non-inferiority trial conducted in two hospitals, included patients undergoing distal upper limb surgery. Patients were randomly assigned to a brachial plexus block (ICB or RCB). The primary outcome was performance time (sum of visualization and needling time), and was analyzed with a non-inferiority test of averages. Depth of sensory and motor blockade, surgical success, total anesthesia time, needle visualization, number of needle passes and complications were also evaluated. Subgroup analysis restricted to patients with higher body mass index was completed. Results We included 109 patients between September 2016 and May 2017. Mean RCB performance time was 4.8 ± 2.0 min while ICB was 5.2 ± 2.3 min ( p  = 0.06) with a 95% CI reaching up to 5.8% longer. RCB conferred an ultrasound-needle angle closer to 0 ° and significantly improved needle visibility after the clavicle was cleared and before local anesthetic administration. No differences were found in the secondary outcomes. Similar results were found in the subgroup analysis. Conclusion RCB approach for brachial plexus anesthesia was similar to ICB approach in terms of time performance. Needle visibility, which represent an important clinical variable, was superior and angle between needle and ultrasound probe was close to 0° in the RCB group. Clinical trial registration ClinicalTrials.gov (NCT02913625), registered 26 September 2016.
The applications of ChatGPT and other large language models in anesthesiology and critical care: a systematic review
ChatGPT and other large language models (LLMs) have gained immense popularity since their commercial release in 2022, with applications in various sectors including health care. We sought to evaluate their deployment in anesthesiology and critical care in a systematic review. Our aim was to describe the integration of LLMs in the field by showcasing and categorizing their current applications, assessing their performance in patient care, and reviewing application-specific ethical and practical challenges in deployment. Respecting Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines, we systematically searched through PubMed®, Embase, the Cochrane Central Register of Controlled Trials, and Web of Science®, from inception until 1 August 2024. We extracted all papers investigating LLMs in anesthesiology or critical care and reporting results. We segmented the literature into major themes and highlighted key findings and limitations. From 480 retrieved articles, we included 45 papers. The evaluated models (GPT-4, GPT-3.5, Google Bard [now Gemini], LLaMA, and others) showed diverse applications in four segments: intensive care unit, patient education, medical education, and perioperative care. Large language models, especially newer models, are promising in predicting clinical scores, navigating simple clinical scenarios, and managing preoperative anxiety. Their performance remains below the clinician level in predicting outcomes, solving complex clinical scenarios (i.e., airway management), board examinations, and generating patient-directed documents, although newer models performed better than older ones. While LLMs are not yet equipped to fully assist physicians in anesthesiology and critical care, they have significant potential, and their capabilities are rapidly improving. Supervised use for select tasks can streamline patient care. Further trials are warranted as new versions of models become available. PROSPERO ( CRD42024567380 ); first submitted 22 July 2024.
A randomized controlled trial comparing three supraglottic airway devices used as a conduit to facilitate tracheal intubation with flexible bronchoscopy
Purpose Once difficult ventilation and intubation are declared, guidelines suggest the use of a supraglottic airway (SGA) as a rescue device to ventilate and, if oxygenation is restored, subsequently as an intubation conduit. Nevertheless, few trials have formally studied recent SGA devices in patients. Our objective was to compare the efficacy of three second-generation SGA devices as conduits for bronchoscopy-guided endotracheal intubation. Methods In this prospective, single-blinded three-arm randomized controlled trial, patients with an American Society of Anesthesiologists Physical Status of I–III undergoing general anesthesia were randomized to bronchoscopy-guided endotracheal intubation using AuraGain™, Air-Q® Blocker, or i-gel® devices. We excluded patients with contraindications to an SGA or drugs and who were pregnant or had a neck, spine, or respiratory anomaly. The primary outcome was intubation time, measured from SGA circuit disconnection to CO 2 measurement. Secondary outcomes included ease, time, and success of SGA insertion; success of intubation on first attempt; overall intubation success; number of attempts to intubate; ease of intubation; and ease of SGA removals. Results One hundred and fifty patients were enrolled from March 2017 to January 2018. Median intubation times were similar across the three groups (Air-Q Blocker, 44 sec; AuraGain, 45 sec; i-gel, 36 sec; P = 0.08). The i-gel was faster to insert (i-gel: 10 sec; Air-Q Blocker, 16 sec; AuraGain, 16 sec; P < 0.001) and easier to insert (Air-Q Blocker vs i-gel, P = 0.001; AuraGain vs i-gel, P = 0.002). Success of SGA insertion, success of intubation, and number of attempts were similar. The Air-Q Blocker was easier to remove than the i-gel ( P < 0.001). Conclusion All three second-generation SGA devices performed similarly regarding intubation. Despite minor benefits of the i-gel, clinicians should select their SGA based on clinical experience. Study registration ClinicalTrials.gov (NCT02975466); registered on 29 November 2016.
Prediction of acute postoperative pain based on intraoperative nociception level (NOL) index values: the impact of machine learning-based analysis
The relationship between intraoperative nociception and acute postoperative pain is still not well established. The nociception level (NOL) Index (Medasense, Ramat Gan, Israel) uses a multiparametric approach to provide a 0–100 nociception score. The objective of the ancillary analysis of the NOLGYN study was to evaluate the ability of a machine-learning aglorithm to predict moderate to severe acute postoperative pain based on intraoperative NOL values. Our study uses the data from the NOLGYN study, a randomized controlled trial that evaluated the impact of NOL-guided intraoperative administration of fentanyl on overall fentanyl consumption compared to standard of care. Seventy patients (ASA class I–III, aged 18–75 years) scheduled for gynecological laparoscopic surgery were enrolled. Variables included baseline demographics, NOL reaction to incision or intubation, median NOL during surgery, NOL time-weighted average (TWA) above or under manufacturers’ recommended thresholds (10–25), and percentage of surgical time spent with NOL > 25 or < 10. We evaluated different machine learning algorithms to predict postoperative pain. Performance was assessed using cross-validated area under the ROC curve (CV-AUC). Of the 66 patients analyzed, 42 (63.6%) experienced moderate to severe pain. NOL post-intubation (42.8 (31.8–50.6) vs. 34.8 (25.6–41.3), p = 0.05), median NOL during surgery (13 (11–15) vs. 11 (8–13), p = 0.027), percentage of surgical time spent with NOL > 25 (23% (18–18) vs. 20% (15–24), p = 0.036), NOL TWA < 10 (2.54 (2.1–3.0) vs. 2.86 (2.48–3.62), p = 0.044) and percentage of surgical time spent with NOL < 10 (41% (36–47) vs. 47% (40–55), p = 0.022) were associated with moderate to severe PACU pain. Corresponding ROC AUC for the prediction of moderate to severe PACU pain were 0.65 [0.51–0.79], 0.66 [0.52–0.81], 0.66 [0.52–0.79], 0.65 [0.51–0.79] and 0.67 [0.53–0.81]. Penalized logistic regression achieved the best performance with a 0.753 (0.718–0.788) CV-AUC. Our results, even if limited by the small number of patients, suggest that acute postoperative pain is better predicted by a multivariate machine-learning algorithm rather than individual intraoperative nociception variables. Further larger multicentric trials are highly recommended to better understand the relationship between intraoperative nociception and acute postoperative pain.Trial registration Registered on ClinicalTrials.gov in October 2018 (NCT03776838).
Impact of deep neuromuscular blockade on intraoperative NOL-guided remifentanil requirement during desflurane anesthesia in laparoscopic colorectal surgeries: A randomised controlled trial
Evaluate the impact of deep neuromuscular blockade on intraoperative nociception Deep neuromuscular blockade has been shown to improve surgical conditions and postoperative outcomes compared to moderate neuromuscular blockade in laparoscopic surgery. Still, its impact on intraoperative nociception and opioid requirement has never been assessed. Monocentric randomised controlled trial. Operating room. We included 100 ASA I to III patients who underwent colorectal laparoscopic surgery with desflurane-remifentanil anesthesia. Patients were randomised into two groups to achieve either moderate (1–3 train of four response) or deep (1–2 post-tetanic count) neuromuscular block (NMB) with repeated boluses of rocuronium. The Nociception Level (NOL) index guided intraoperative remifentanil administration in both groups. The primary endpoint was total intraoperative remifentanil administration per hour of surgery. Secondary endpoints included, Leiden Surgical Rating Scale (L-SRS), intra-abdominal pressure, postoperative pain scores and opioids' consumption. Ninety-three patients were analysed. Forty-five in the deep group and 48 patients in moderate group. Intraoperative administration of remifentanil was 348 (228–472) μg.h−1 in the deep NMB group compared to 494 (392–618) μg.h−1 in the moderate NMB group (P < 0.001). Lowest L-SRS was 5 (4–5) in the deep NMB group versus 3 (2–5) (P < 0.001) in the moderate NMB group. Mean intra-abdominal pressure was 11.9 (1.3) in the deep NMB group versus 13 (1.3) (P < 0.001) in the moderate NMB group. Secondary postoperative outcomes including pain scores and analgesics administration were not significantly different. This study shows that deep neuromuscular blockade reduces intraoperative NOL-guided administration of remifentanil in colorectal laparoscopic surgeries. It also improves surgical conditions. The study was registered at ClinicalTrials.gov under NCT03910998. •Deep neuromuscular block NMB reduces NOL-guided remifentanil administration by 30 % during laparoscopic colorectal surgery.•Deep neuromuscular block improves surgical satisfaction and reduces intra-abdominal pressure during laparoscopic surgery.•Postoperative outcomes including postoperative pain scores and opioids' consumption were similar between groups.
Using the nociception level index to compare the intraoperative antinociceptive effect of propofol and sevoflurane during clinical and experimental noxious stimulus in patients under general anesthesia
Propofol and sevoflurane are two anesthetic agents widely used to induce and maintain general anesthesia (GA). Their intrinsic antinociceptive properties remain unclear and are still debated. To determine whether propofol presents stronger antinociceptive properties than sevoflurane using intraoperative clinical and experimental noxious stimulations and evaluating postoperative pain outcomes. A prospective randomized monocentric trial. Perioperative care. 60 adult patients with ASA status I to III who underwent elective abdominal laparoscopic surgery under GA were randomized either in propofol or sevoflurane group to induce and maintain GA. We used clinical and experimental noxious stimulations (intubation, tetanic stimulation) to assess the antinociceptive properties of propofol and sevoflurane in patients under GA and monitored using the NOL index, BIS index, heart rate, and mean arterial blood pressure. We measured the difference in the NOL index alterations after intubation and tetanic stimulation during either intravenous anesthesia (propofol) or inhaled anesthesia (sevoflurane). We also intraoperatively measured the NOL index and remifentanil consumption and recorded postoperative pain scores and opioid consumption in the post-anesthesia care unit. Intraoperative management was standardized by targeting similar values of depth of anesthesia (BIS index), hemodynamic (HR and MAP), NOL index values (below the threshold of 20), same multimodal analgesia and type of surgery. We found the antinociceptive properties of propofol and sevoflurane similar. The only minor difference was after tetanic stimulation: the delta NOL was higher in the sevoflurane group (39 ± 13 for the propofol group versus 47 ± 15 for sevoflurane; P = 0.04). Intraoperative and postoperative pain outcomes and opioid consumption were similar between groups. Despite a precise intraoperative experimental and clinical protocol using the NOL index, propofol does not provide a higher level of antinociception during anesthesia or analgesia after surgery when compared to sevoflurane. Anesthesiologists may prefer propofol over sevoflurane to reduce PONV or anesthesia-related pollution, but not for superior antinociceptive properties. •Propofol and sevoflurane's intrinsic antinociceptive properties are not yet clear.•Objective measurement of intraoperative nociception using the multiparametric NOL index helps precisely evaluate noxious stimulations.•Propofol and sevoflurane intraoperative antinociceptive properties were found to be similar.•No difference was observed in postoperative pain scores and consumption of analgesics.