Clinical trial NCT05643066: Esketamine-propofol Versus Propofol for Flexible Bronchoscopy
Official title: Discharge Readiness After Propofol With or Without Esketamine for Outpatient Flexible Bronchoscopy: a Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Recovery
Keywords: bronchoscopy
esketamine
procedure sedation
propofol
Lead sponsor: Fujian Provincial Hospital
Sponsor class: OTHER
First posted: 2022-12-08
Enrollment: 246
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. American Society of Anesthesiologists (ASA) classification I-III;
2. Scheduled for ambulatory bronchoscopy.

Exclusion Criteria:

1. Allergic or contraindications to studying drugs
2. History of obstructive sleep apnea-hypopnea syndrome
3. History of psychiatric illness
4. History of neurological disease
5. Pre-existing memory or cognitive impairment
6. History of seizure disorders
7. Pregnancy
8. Substance abuse or intake of drugs that affect the central nervous system
9. Inability to communicate in Mandarin Chinese.
10. Illiteracy

Primary outcomes:
measure: Proportions of patients discharged within 30 min after bronchoscopy
timeFrame: Up to 40 minutes postoperatively
Secondary outcomes:
measure: Postoperative quality of recovery
timeFrame: Baseline, up to 72 hours postoperatively
measure: Injection pain
timeFrame: Immediately after administering the study drugs, on average 2 minutes
measure: Emergency time
timeFrame: Immediately after the bronchoscopy completely withdrawn, on average 8 minutes
measure: Incidence of adverse events
timeFrame: Up to 72 h postoperatively
measure: Propofol consumption
timeFrame: During the bronchoscopy procedure
measure: Patient willingness to repeat the procedure
timeFrame: 24 hours postoperatively
measure: Bronchoscopist satisfaction
timeFrame: At completion of bronchoscopy procedure
measure: Patient satisfaction
timeFrame: At completion of bronchoscopy procedure
measure: Patient willingness to recommend screening
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian provincial hospital
state: Fujian
Study officials:
affiliation: Fujian Provincial Hospital
name: Xiaochun Zheng, MD
role: STUDY_CHAIR
References: