Fujian provincial hospital
Fuzhou, Fujian, 350001, China
NCT Number: NCT05643066
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.
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Notify Me18 year–75 year
All sexes
Interventional
Phase 4
Fuzhou, Fujian, 350001, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Esketamine 0.1 mg/kg was intravenously injected first.
Other names: S-ketamine 0.1 mg/kg
Esketamine 0.2 mg/kg was intravenously injected first.
Other names: S-ketamine 0.2 mg/kg
0.9% saline was intravenously injected first.
Other names: Normal saline
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 names: propofol injection
Time frame: Up to 40 minutes postoperatively
Discharge readiness will be measured using the Modified Post Anesthetic Discharge Scoring System scale (greater than or equal to nine).
Time frame: Baseline, up to 72 hours postoperatively
Postoperative quality of recovery will be measured using the Postoperative Quality of Recovery Scale (PostopQRS). The PostopQRS is a digital measurement tool to quantify physiological, emotive, nociceptive, activities of daily living, and cognitive domain of postoperative recovery over time. Recovery in various domains of the PostopQRS is defined by postoperative values equaling or exceeding individual baseline values.
Time frame: Immediately after administering the study drugs, on average 2 minutes
Injection pain was assessed using a numeric rating scale of 0 to 10 (0 equals no pain, and 10 equals the worst pain imaginable).
Time frame: Immediately after the bronchoscopy completely withdrawn, on average 8 minutes
Emergency time was defined as the interval from the end of bronchoscopy to the MOAA/S score equal to five.
Time frame: Up to 72 h postoperatively
Episodes of adverse events such as bradycardia, tachycardia, hypotension, hypertension, hypoxia, nausea, vomiting, nightmare, and blurred vision
Time frame: During the bronchoscopy procedure
Propofol consumption will be recorded during the bronchoscopy procedure.
Time frame: 24 hours postoperatively
Patients will be asked whether they would repeat the identical procedural process (Yes/No/Unsure).
Time frame: At completion of bronchoscopy procedure
Bronchoscopist satisfaction will be evaluated using a five-point Likert scale (5=very satisfied, 4=satisfied, 3=neither satisfied nor dissatisfied, 2=dissatisfied, and 1=very dissatisfied).
Time frame: At completion of bronchoscopy procedure
Bronchoscopist satisfaction will be evaluated using a five-point Likert scale (5=very satisfied, 4=satisfied, 3=neither satisfied nor dissatisfied, 2=dissatisfied, and 1=very dissatisfied).
Time frame: 24 hours postoperatively
Patients will be asked whether they would recommend bronchoscopy screening to a friend or a relative (Yes/No/Unsure).
Fujian Provincial Hospital
Other
Discharge Readiness After Propofol With or Without Esketamine for Outpatient Flexible Bronchoscopy: a Randomized, Controlled Study
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