Esketamine-propofol Versus Propofol for Flexible Bronchoscopy
Condition: Postoperative Recovery
Study type: Interventional
Phase: Phase 4

Summary: 
      Bronchoscopy is a promising technology for lung and bronchus disease detection and therapy.
      However, this procedure is associated with a relatively high risk of hypoxemia, coughing,
      wheezing, and dyspnea. Despite the fact that propofol is the most commonly used agent in
      procedure sedation, the narrow therapeutic index remains challenging. Esketamine is the
      s-enantiomer of ketamine with potent analgesic and sedative properties. This study aims to
      test the hypothesis that adding subanesthetic esketamine to propofol is non-inferior to
      propofol alone for bronchoscopy on the recovery profile and discharge from the hospital.
    

Detailed description: 
      Bronchoscopy is one of the most common procedures to detect lung and bronchus disease. The
      procedure is generally uncomfortable and associated with a relatively high risk of hypoxemia,
      coughing, wheezing, and dyspnea. Therefore, physicians are placing increasing importance on
      the use of procedure sedation due to the demand for comfortable medical care.

      Propofol is an effective agent for sedation in bronchoscopy with rapid onset and recovery.
      However, the safety endpoints of propofol are not cost-effective, including injection pain,
      hypotension, apnea, airway compromise, and without a reversal agent. Specifically, the
      depressive effects on the respiratory system are more noteworthy in bronchoscopy, which may
      lead to hypoxia. These drawbacks may hinder functional recovery and delay the discharge time.
      Hence, physicians are searching for an optimal sedation regimen for bronchoscopy.

      Esketamine, the s-enantiomer of ketamine, is an N-methyl-D-aspartic acid receptor antagonist
      with potent analgesic and sedative properties. Evidence suggested that esketamine could be
      used as a component of sedative regimen in many settings, such as endoscopy and endoscopic
      retrograde cholangiopancreatography. Nevertheless, there remains an evidence gap in the
      efficacy and safety of esketamine used in bronchoscopy. Therefore, we conducted this study to
      test the hypothesis that low-dose esketamine as an adjuvant to propofol was non-inferior to
      propofol alone on the recovery profile and discharge from the hospital after ambulatory
      bronchoscopy.
    

Intervention name(s): 0.1 mg/kg esketamine; 0.2 mg/kg esketamine; 0.9% saline; Propofol
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Esketamine 0.1 mg/kg was intravenously injected first.; Esketamine 0.2 mg/kg was intravenously injected first.; 0.9% saline was intravenously injected first.; Propofol 1 mg/kg was injected immediately. Afterward, propofol 0.5 mg/kg was administered to maintain the target sedation level (MOAA/S of less than three).
Other intervention name(s): S-ketamine 0.1 mg/kg; S-ketamine 0.2 mg/kg; Normal saline; propofol injection
Intervention MeSH terms: Ketamine; Propofol; Esketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: bronchoscopy; esketamine; procedure sedation; propofol