ABSTRACT
Importance: It is uncertain whether a rapid-onset opioid is noninferior to a rapid-onset neuromuscular blocker during rapid sequence intubation when used in conjunction with a hypnotic agent. Objective: To determine whether remifentanil is noninferior to rapid-onset neuromuscular blockers for rapid sequence intubation. Design, Setting, and Participants: Multicenter, randomized, open-label, noninferiority trial among 1150 adults at risk of aspiration (fasting for <6 hours, bowel occlusion, recent trauma, or severe gastroesophageal reflux) who underwent tracheal intubation in the operating room at 15 hospitals in France from October 2019 to April 2021. Follow-up was completed on May 15, 2021. Interventions: Patients were randomized to receive neuromuscular blockers (1 mg/kg of succinylcholine or rocuronium; n = 575) or remifentanil (3 to 4 µg/kg; n = 575) immediately after injection of a hypnotic. Main Outcomes and Measures: The primary outcome was assessed in all randomized patients (as-randomized population) and in all eligible patients who received assigned treatment (per-protocol population). The primary outcome was successful tracheal intubation on the first attempt without major complications, defined as lung aspiration of digestive content, oxygen desaturation, major hemodynamic instability, sustained arrhythmia, cardiac arrest, and severe anaphylactic reaction. The prespecified noninferiority margin was 7.0%. Results: Among 1150 randomized patients (mean age, 50.7 [SD, 17.4] years; 573 [50%] women), 1130 (98.3%) completed the trial. In the as-randomized population, tracheal intubation on the first attempt without major complications occurred in 374 of 575 patients (66.1%) in the remifentanil group and 408 of 575 (71.6%) in the neuromuscular blocker group (between-group difference adjusted for randomization strata and center, -6.1%; 95% CI, -11.6% to -0.5%; P = .37 for noninferiority), demonstrating inferiority. In the per-protocol population, 374 of 565 patients (66.2%) in the remifentanil group and 403 of 565 (71.3%) in the neuromuscular blocker group had successful intubation without major complications (adjusted difference, -5.7%; 2-sided 95% CI, -11.3% to -0.1%; P = .32 for noninferiority). An adverse event of hemodynamic instability was recorded in 19 of 575 patients (3.3%) with remifentanil and 3 of 575 (0.5%) with neuromuscular blockers (adjusted difference, 2.8%; 95% CI, 1.2%-4.4%). Conclusions and Relevance: Among adults at risk of aspiration during rapid sequence intubation in the operating room, remifentanil, compared with neuromuscular blockers, did not meet the criterion for noninferiority with regard to successful intubation on first attempt without major complications. Although remifentanil was statistically inferior to neuromuscular blockers, the wide confidence interval around the effect estimate remains compatible with noninferiority and limits conclusions about the clinical relevance of the difference. Trial Registration: ClinicalTrials.gov Identifier: NCT03960801.
Subject(s)
Analgesics, Opioid , Intubation, Intratracheal , Neuromuscular Blocking Agents , Rapid Sequence Induction and Intubation , Remifentanil , Respiratory Aspiration , Adult , Female , Humans , Male , Middle Aged , Hypnotics and Sedatives/administration & dosage , Hypnotics and Sedatives/adverse effects , Hypnotics and Sedatives/therapeutic use , Intubation, Intratracheal/adverse effects , Intubation, Intratracheal/methods , Neuromuscular Blocking Agents/administration & dosage , Neuromuscular Blocking Agents/adverse effects , Neuromuscular Blocking Agents/therapeutic use , Rapid Sequence Induction and Intubation/adverse effects , Rapid Sequence Induction and Intubation/methods , Remifentanil/administration & dosage , Remifentanil/adverse effects , Remifentanil/therapeutic use , Respiratory Aspiration/etiology , Respiratory Aspiration/prevention & control , Analgesics, Opioid/administration & dosage , Analgesics, Opioid/adverse effects , Analgesics, Opioid/therapeutic use , AgedABSTRACT
BACKGROUND: A catheter in femoral nerve block (F-Cath) is an effective regional analgesia technique in total knee arthroplasty (TKA) but results in significant quadriceps weakness. The femoral triangle catheter (FTB-Cath) seems to be an interesting alternative. In this study, we aim to demonstrate that the nerve block administration for analgesic purposes via an FTB-Cath results in less quadriceps weakness than via an F-Cath. METHODS: This study included patients scheduled for TKA performed under general anaesthesia. The patients were randomised to receive either an F-Cath or an FTB-Cath. A unique regimen of 0.2% ropivacaine was administrated for 72 h. The primary endpoint was quadriceps strength assessed clinically on postoperative day (POD) 2 by the Manual Muscle Test (MMT) using a motor grading scores (0-5). The secondary endpoints were quadriceps strength measured by a dynamometer, the Timed Up and Go (TUG) test, the 30-m walk test (30MWT) and pain scores. RESULTS: Forty-four patients were analysed (22 in each group). On POD 2, 77.3% of the patients in the FTB-Cath group had MMT scores ≥ 4 and 13.6% in the F-Cath group (p < 0.001). During the first four POD assessments, quadriceps strength evaluated with a dynamometer was less diminished in the FTB-Cath group (p < 0,001). There was no difference between groups regarding pain scores, TUG test results and 30MWT assessment. CONCLUSION: The FTB-Cath provided a better preservation of quadriceps strength than the F-Cath in TKA, with a similar pain relief.
Subject(s)
Analgesia , Arthroplasty, Replacement, Knee , Analgesia/methods , Analgesics, Opioid , Anesthetics, Local , Arthroplasty, Replacement, Knee/methods , Femoral Nerve , Humans , Pain, Postoperative/drug therapy , Prospective StudiesABSTRACT
BACKGROUND: Rapid-onset paralytic agents are recommended to achieve muscle relaxation and facilitate tracheal intubation during rapid sequence induction in patients at risk of pulmonary aspiration of gastric contents. However, opioids are frequently used in this setting. The study's objective is to demonstrate the non-inferiority of remifentanil compared to rapid-onset paralytic agents, in association with an hypnotic drug, for tracheal intubation in patients undergoing procedure under general anesthesia and at risk of pulmonary aspiration of gastric contents. METHODS: The REMICRUSH (Remifentanil for Rapid Sequence Induction of Anaesthesia) study is a multicenter, single-blinded, non-inferiority randomized controlled trial comparing remifentanil (3 to 4 µg/kg) with rapid-onset paralytic agents (succinylcholine or rocuronium 1 mg/kg) for rapid sequence induction in 1150 adult surgical patients requiring tracheal intubation during general anesthesia. Enrolment started in October 2019 in 15 French anesthesia units. The expected date of the final follow-up is October 2021. The primary outcome is the proportion of successful tracheal intubation without major complications. A non-inferiority margin of 7% was chosen. Analyses of the intent-to-treat and per-protocol populations are planned. DISCUSSION: The REMICRUSH trial protocol has been approved by the ethics committee of The Comité de Protection des Personnes Sud-Ouest et Outre-Mer II and will be carried out according to the principles of the Declaration of Helsinki and the Good Clinical Practice guidelines. The results of this study will be disseminated through presentations at scientific conferences and publications in peer-reviewed journals. The REMICRUSH trial is the first randomized controlled trial powered to investigate whether remifentanil with hypnotics is non-inferior to rapid-onset paralytic agents with hypnotic in rapid sequence induction of anesthesia for full stomach patients considering successful tracheal intubation without major complication. TRIAL REGISTRATION: ClinicalTrials.gov NCT03960801. Registered on May 23, 2019.