Esketamine-propofol Versus Propofol for Flexible Bronchoscopy

Postoperative Recovery Clinical Trial

Official title:

Discharge Readiness After Propofol With or Without Esketamine for Outpatient Flexible Bronchoscopy: a Randomized, Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05643066
• Other study ID #: K2021-12-067
• Status: Completed
• Phase: Phase 4
• Start date: December 7, 2022
• Est. completion date: December 21, 2023

Study information

• Verified date: January 2024
• Source: Fujian Provincial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 246
• Est. completion date: December 21, 2023
• Est. primary completion date: December 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Postoperative Recovery

Intervention

Drug:
• 0.1 mg/kg esketamine
Esketamine 0.1 mg/kg was intravenously injected first.
• 0.2 mg/kg esketamine
Esketamine 0.2 mg/kg was intravenously injected first.
• 0.9% saline
0.9% saline was intravenously injected first.
• Propofol
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).

Locations

Country	Name	City	State
China	Fujian provincial hospital	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Provincial Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportions of patients discharged within 30 min after bronchoscopy	Discharge readiness will be measured using the Modified Post Anesthetic Discharge Scoring System scale (greater than or equal to nine).	Up to 40 minutes postoperatively
Secondary	Postoperative quality of recovery	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.	Baseline, up to 72 hours postoperatively
Secondary	Injection pain	Injection pain was assessed using a numeric rating scale of 0 to 10 (0 equals no pain, and 10 equals the worst pain imaginable).	Immediately after administering the study drugs, on average 2 minutes
Secondary	Emergency time	Emergency time was defined as the interval from the end of bronchoscopy to the MOAA/S score equal to five.	Immediately after the bronchoscopy completely withdrawn, on average 8 minutes
Secondary	Incidence of adverse events	Episodes of adverse events such as bradycardia, tachycardia, hypotension, hypertension, hypoxia, nausea, vomiting, nightmare, and blurred vision	Up to 72 h postoperatively
Secondary	Propofol consumption	Propofol consumption will be recorded during the bronchoscopy procedure.	During the bronchoscopy procedure
Secondary	Patient willingness to repeat the procedure	Patients will be asked whether they would repeat the identical procedural process (Yes/No/Unsure).	24 hours postoperatively
Secondary	Bronchoscopist satisfaction	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).	At completion of bronchoscopy procedure
Secondary	Patient satisfaction	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).	At completion of bronchoscopy procedure
Secondary	Patient willingness to recommend screening	Patients will be asked whether they would recommend bronchoscopy screening to a friend or a relative (Yes/No/Unsure).	24 hours postoperatively