Postoperative RecoveryPhase 4NCT05643066
Esketamine-propofol Versus Propofol for Flexible Bronchoscopy
A Phase 4 study testing 0.1 mg/kg esketamine, 0.2 mg/kg esketamine and 0.9% saline in people with Postoperative Recovery, run by Fujian Provincial Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Recovery
- What is being tested?
- 0.1 mg/kg esketamine, 0.2 mg/kg esketamine and 0.9% saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 246 participants
- Where
- 1 siteChina
- Study dates
- 7 Dec 2022to 21 Dec 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) classification I-III;
- Scheduled for ambulatory bronchoscopy.
Who cannot join
- Allergic or contraindications to studying drugs
- History of obstructive sleep apnea-hypopnea syndrome
- History of psychiatric illness
- History of neurological disease
- Pre-existing memory or cognitive impairment
- History of seizure disorders
Show all 10Show fewer
- Pregnancy
- Substance abuse or intake of drugs that affect the central nervous system
- Inability to communicate in Mandarin Chinese.
- Illiteracy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Postoperative Recovery
- Being tested
- 0.1 mg/kg esketamine, 0.2 mg/kg esketamine, 0.9% saline, Propofol
- Keywords
- bronchoscopy, esketamine, procedure sedation, propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.1 mg/kg esketamineDrug
Also called S-ketamine 0.1 mg/kg
Esketamine 0.1 mg/kg was intravenously injected first.
0.2 mg/kg esketamineDrug
Also called S-ketamine 0.2 mg/kg
Esketamine 0.2 mg/kg was intravenously injected first.
0.9% salineDrug
Also called Normal saline
0.9% saline was intravenously injected first.
PropofolDrug
Also called propofol injection
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).
| Study group | Role | What they receive |
|---|---|---|
| 0.1 mg/kg esketamine group | Experimental | 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). Receives: Drug: 0.1 mg/kg esketamine; Drug: Propofol |
| 0.2 mg/kg esketamine group | Experimental | 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). Receives: Drug: 0.2 mg/kg esketamine; Drug: Propofol |
| Placebo group | Placebo comparator | 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). Receives: Drug: 0.9% saline; Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 40 minutes postoperatively
Secondary outcomes (9)
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.
Measured: 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).
Measured: 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.
Measured: 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
Measured: Up to 72 h postoperatively
Propofol consumption
Propofol consumption will be recorded during the bronchoscopy procedure.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start7 Dec 2022
- Primary completion18 Dec 2023
- Study completion21 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative RecoveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujian Provincial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yao Yusheng, Fujian Provincial Hospital
- Investigators
- Xiaochun Zheng, MD, Study chair, Fujian Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05643066
- Sponsor's protocol ID
- K2021-12-067
- Status last verified
- Dec 2025
- First submitted
- 14 Nov 2022
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Zhang X, Chen L, Chen Z, Yang J, Zheng T, Lin W, Guan J, Yao Y. Discharge Readiness After Propofol with or without Esketamine for Flexible Bronchoscopy: A Randomized Non-Inferiority Trial. Drug Des Devel Ther. 2026 Jun 22;20:612153. doi: 10.2147/DDDT.S612153. eCollection 2026.
PubMed 42369372
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discharge Readiness After Propofol With or Without Esketamine for Outpatient Flexible Bronchoscopy: a Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT05643066
- Acronym / sponsor ID
- K2021-12-067
- Conditions
- Postoperative Recovery
- Keywords
- bronchoscopy, esketamine, procedure sedation, propofol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- Fujian Provincial HospitalUniversity, hospital or other
- Study start
- 7 Dec 2022 (actual)
- Primary completion
- 18 Dec 2023 (actual)
- Study completion
- 21 Dec 2023 (actual)
- First posted
- 8 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 0.1 mg/kg esketamine group | Experimental | Drug: 0.1 mg/kg esketamine, Drug: PropofolProcedure 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). |
| 0.2 mg/kg esketamine group | Experimental | Drug: 0.2 mg/kg esketamine, Drug: PropofolProcedure 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). |
| Placebo group | Placebo comparator | Drug: 0.9% saline, Drug: PropofolProcedure 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). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) classification I-III;
- Scheduled for ambulatory bronchoscopy.
Key exclusion criteria (10 listed)
- Allergic or contraindications to studying drugs
- History of obstructive sleep apnea-hypopnea syndrome
- History of psychiatric illness
- History of neurological disease
- Pre-existing memory or cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.1 mg/kg esketamineAlso: S-ketamine 0.1 mg/kgEsketamine 0.1 mg/kg was intravenously injected first. | Drug | 0.1 mg/kg esketamine group |
| 0.2 mg/kg esketamineAlso: S-ketamine 0.2 mg/kgEsketamine 0.2 mg/kg was intravenously injected first. | Drug | 0.2 mg/kg esketamine group |
| 0.9% salineAlso: Normal saline0.9% saline was intravenously injected first. | Drug | Placebo group |
| PropofolAlso: propofol injectionPropofol 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). | Drug | 0.1 mg/kg esketamine group, 0.2 mg/kg esketamine group, Placebo group |
Primary outcome
Proportions of patients discharged within 30 min after bronchoscopy
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).
9 secondary outcomes
Postoperative quality of recovery
Time frame: Baseline, up to 72 hours postoperatively
Injection pain
Time frame: Immediately after administering the study drugs, on average 2 minutes
Emergency time
Time frame: Immediately after the bronchoscopy completely withdrawn, on average 8 minutes
Incidence of adverse events
Time frame: Up to 72 h postoperatively
Propofol consumption
Time frame: During the bronchoscopy procedure
Patient willingness to repeat the procedure
Time frame: 24 hours postoperatively
Bronchoscopist satisfaction
Time frame: At completion of bronchoscopy procedure
Patient satisfaction
Time frame: At completion of bronchoscopy procedure
Patient willingness to recommend screening
Time frame: 24 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Derived from this study: PubMed 42369372Zhang X, Chen L, Chen Z, Yang J, Zheng T, Lin W, Guan J, Yao Y. Discharge Readiness After Propofol with or without Esketamine for Flexible Bronchoscopy: A Randomized Non-Inferiority Trial. Drug Des Devel Ther. 2026 Jun 22;20:612153. doi: 10.2147/DDDT.S612153. eCollection 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaochun Zheng, MD study chair
Fujian Provincial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 0.1 mg/kg esketamine, 0.2 mg/kg esketamine and 0.9% saline in people with Postoperative Recovery, run by Fujian Provincial Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportions of patients discharged within 30 min after bronchoscopy (time frame: Up to 40 minutes postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05643066, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.