Annals of medicine · 2025
Intravenous lidocaine as an adjuvant to propofol sedation for elderly patients undergoing same-visit bidirectional endoscopy: protocol for a multicenter randomized controlled trial.
СтатьяПротокол клинического исследованияПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Liu Ying, Song Nan, Zhang Jing-Tao, Yan Jing, Peng Ke, Liu Hong, Shan Xi-Sheng, Ji Fu-Hai
Аннотация
BACKGROUND: Same-visit bidirectional endoscopic procedures under sedation are frequently performed in elderly patients. However, the optimal sedation regimen for elderly patients remains uncertain. This study seeks to evaluate the hypothesis that intravenous lidocaine, when used as an adjunct to propofol sedation, reduces the incidence of sedation-related adverse events during these procedures.
METHODS: This multicenter, randomized, double-blind, placebo-controlled trial will enroll 648 elderly patients scheduled for same-visit bidirectional endoscopy under sedation at four hospitals in China. Participants will be randomized in a 1:1 ratio to receive either intravenous lidocaine or normal saline (placebo), stratified by study center (n = 324 per group). All patients will receive sufentanil (0.1 μg/kg) followed by either lidocaine (1.5 mg/kg) or an equal volume of normal saline, and then propofol (1.0 mg/kg) for induction. Propofol will be titrated to maintain the target sedation level. The primary outcome is a composite of desaturation (peripheral oxygen saturation < 90%) and hypotension (systolic blood pressure < 90 mmHg or > 20% reduction from baseline). Secondary outcomes include total propofol dose, incidence of involuntary body movements, postoperative pain and fatigue scores, and recovery time. Analyses will follow a modified intention-to-treat approach.
DISCUSSION: We hypothesize that adjunctive lidocaine with propofol-based sedation will reduce the incidence of intraoperative desaturation and hypotension in elderly patients undergoing same-visit bidirectional endoscopy. The findings will contribute to optimizing sedation strategies in this vulnerable population.
TRIAL REGISTRATION: Chinese Clinical Trial Registry (ChiCTR2400087583).
METHODS: This multicenter, randomized, double-blind, placebo-controlled trial will enroll 648 elderly patients scheduled for same-visit bidirectional endoscopy under sedation at four hospitals in China. Participants will be randomized in a 1:1 ratio to receive either intravenous lidocaine or normal saline (placebo), stratified by study center (n = 324 per group). All patients will receive sufentanil (0.1 μg/kg) followed by either lidocaine (1.5 mg/kg) or an equal volume of normal saline, and then propofol (1.0 mg/kg) for induction. Propofol will be titrated to maintain the target sedation level. The primary outcome is a composite of desaturation (peripheral oxygen saturation < 90%) and hypotension (systolic blood pressure < 90 mmHg or > 20% reduction from baseline). Secondary outcomes include total propofol dose, incidence of involuntary body movements, postoperative pain and fatigue scores, and recovery time. Analyses will follow a modified intention-to-treat approach.
DISCUSSION: We hypothesize that adjunctive lidocaine with propofol-based sedation will reduce the incidence of intraoperative desaturation and hypotension in elderly patients undergoing same-visit bidirectional endoscopy. The findings will contribute to optimizing sedation strategies in this vulnerable population.
TRIAL REGISTRATION: Chinese Clinical Trial Registry (ChiCTR2400087583).