Drug design, development and therapy · 2026
Discharge Readiness After Propofol with or without Esketamine for Flexible Bronchoscopy: A Randomized Non-Inferiority Trial.
Equivalence TrialСтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Zhang Xiaohong, Chen Lei, Chen Zaizhi, Yang Jiahan, Zheng Ting, Lin Wenjun, Guan Jinsheng, Yao Yusheng
Аннотация
PURPOSE: To determine whether low-dose esketamine combined with propofol is non-inferior to propofol alone for discharge readiness after outpatient flexible bronchoscopy.
PATIENTS AND METHODS: In this single-center, randomized, double-blind, non-inferiority trial, 246 adults aged 18 to 75 years with ASA physical status I to III scheduled for elective outpatient flexible bronchoscopy were randomly assigned (1:1:1) to propofol alone (propofol plus 0.9% saline; n = 82), propofol plus esketamine 0.1 mg/kg (n = 82), or propofol plus esketamine 0.2 mg/kg (n = 82). The primary endpoint was the proportion achieving discharge readiness (Modified Post-Anesthetic Discharge Scoring System [MPADSS] score ≥ 9) within 30 minutes of procedure completion; the non-inferiority margin was -18 percentage points. Secondary endpoints included propofol consumption, intraoperative cough severity, adverse events, and patient-reported recovery quality.
RESULTS: Both esketamine doses were non-inferior to propofol alone for discharge readiness: the risk difference was -3.0 percentage points (95% CI, -13.8 to 7.8; P non-inferiority = 0.003) at 0.1 mg/kg and -5.1 percentage points (95% CI, -16.2 to 6.1; P non-inferiority = 0.012) at 0.2 mg/kg. In exploratory secondary analyses, both doses reduced propofol consumption (by 20% and 28%; both P < 0.001) and intraoperative cough severity (P = 0.005 and P = 0.002). Hypotension occurred in 42 (51%), 24 (29%), and 10 (12%) participants in the propofol-alone, propofol + esketamine 0.1, and propofol + esketamine 0.2 groups, respectively, and hypoxemia in 17 (21%), 10 (12%), and 3 (4%). Recovery quality was comparable across the three groups.
CONCLUSION: Adding low-dose esketamine to propofol maintained timely discharge readiness during outpatient flexible bronchoscopy. Among the secondary outcomes, esketamine at 0.2 mg/kg was associated with lower rates of hypotension and hypoxemia, although these exploratory findings warrant confirmation.
REGISTRATION: ClinicalTrials.gov Identifier: NCT05643066.
PATIENTS AND METHODS: In this single-center, randomized, double-blind, non-inferiority trial, 246 adults aged 18 to 75 years with ASA physical status I to III scheduled for elective outpatient flexible bronchoscopy were randomly assigned (1:1:1) to propofol alone (propofol plus 0.9% saline; n = 82), propofol plus esketamine 0.1 mg/kg (n = 82), or propofol plus esketamine 0.2 mg/kg (n = 82). The primary endpoint was the proportion achieving discharge readiness (Modified Post-Anesthetic Discharge Scoring System [MPADSS] score ≥ 9) within 30 minutes of procedure completion; the non-inferiority margin was -18 percentage points. Secondary endpoints included propofol consumption, intraoperative cough severity, adverse events, and patient-reported recovery quality.
RESULTS: Both esketamine doses were non-inferior to propofol alone for discharge readiness: the risk difference was -3.0 percentage points (95% CI, -13.8 to 7.8; P non-inferiority = 0.003) at 0.1 mg/kg and -5.1 percentage points (95% CI, -16.2 to 6.1; P non-inferiority = 0.012) at 0.2 mg/kg. In exploratory secondary analyses, both doses reduced propofol consumption (by 20% and 28%; both P < 0.001) and intraoperative cough severity (P = 0.005 and P = 0.002). Hypotension occurred in 42 (51%), 24 (29%), and 10 (12%) participants in the propofol-alone, propofol + esketamine 0.1, and propofol + esketamine 0.2 groups, respectively, and hypoxemia in 17 (21%), 10 (12%), and 3 (4%). Recovery quality was comparable across the three groups.
CONCLUSION: Adding low-dose esketamine to propofol maintained timely discharge readiness during outpatient flexible bronchoscopy. Among the secondary outcomes, esketamine at 0.2 mg/kg was associated with lower rates of hypotension and hypoxemia, although these exploratory findings warrant confirmation.
REGISTRATION: ClinicalTrials.gov Identifier: NCT05643066.