Esketamine-propofol Versus Propofol for Flexible Bronchoscopy

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Recovery
• Intervention / Treatment: Drug: 0.1 mg/kg esketamine; Drug: Propofol; Drug: 0.2 mg/kg esketamine; Drug: 0.9% saline

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.

• Study Type: Interventional
• Enrollment (Actual): 246
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Fujian Provincial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 0.1 mg/kg esketamine group; Procedure sedation was induced using intravenous 0.1 mg/kg esketamine and propofol 1 mg/kg. Afterward, propofol 0.5 mg/kg was administered to maintain the target sedation level (MOAA/S of less than three).	Drug: 0.1 mg/kg esketamine; Esketamine 0.1 mg/kg was intravenously injected first.; Other Names: S-ketamine 0.1 mg/kg; Drug: 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).; Other Names: propofol injection
Experimental: 0.2 mg/kg esketamine group; Procedure sedation was induced using intravenous 0.2 mg/kg esketamine and propofol 1 mg/kg. Afterward, propofol 0.5 mg/kg was administered to maintain the target sedation level (MOAA/S of less than three).	Drug: 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).; Other Names: propofol injection; Drug: 0.2 mg/kg esketamine; Esketamine 0.2 mg/kg was intravenously injected first.; Other Names: S-ketamine 0.2 mg/kg
Placebo Comparator: Placebo group; Procedure sedation was induced using intravenous 0.9% saline and propofol 1 mg/kg. Afterward, propofol 0.5 mg/kg was administered to maintain the target sedation level (MOAA/S of less than three).	Drug: 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).; Other Names: propofol injection; Drug: 0.9% saline; 0.9% saline was intravenously injected first.; Other Names: Normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Propofol consumption	Propofol consumption will be recorded during the bronchoscopy procedure.	During the bronchoscopy procedure
Patient willingness to repeat the procedure	Patients will be asked whether they would repeat the identical procedural process (Yes/No/Unsure).	24 hours postoperatively
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
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
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

Collaborators and Investigators

• Sponsor: Fujian Provincial Hospital
• Investigators: Study Chair: Xiaochun Zheng, MD, Fujian Provincial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2022
• Primary Completion (Actual): December 18, 2023
• Study Completion (Actual): December 21, 2023

Study Registration Dates

• First Submitted: November 14, 2022
• First Submitted That Met QC Criteria: December 1, 2022
• First Posted (Actual): December 8, 2022

Study Record Updates

• Last Update Posted (Actual): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: bronchoscopy; esketamine; propofol; procedure sedation
• Additional Relevant MeSH Terms: Organic Chemicals; Pharmaceutical Preparations; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Phenols; Benzene Derivatives; Crystalloid Solutions; Isotonic Solutions; Solutions; Esketamine; Propofol; Saline Solution
• Other Study ID Numbers: K2021-12-067

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After publication, the individual deidentified participant data underlying published results, the study protocol, and the statistical analysis plan can be accessed upon reasonable request from the corresponding author.
• IPD Sharing Time Frame: We would like to share our individual deidentified participant data beginning three months following the publication of the main results.
• IPD Sharing Access Criteria: All of the individual participant data collected during the trial, the study protocol, the statistical analysis plan, and the clinical study report can be accessed with approval from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No