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Completed

NCT Number: NCT05643066

Esketamine-propofol Versus Propofol for Flexible Bronchoscopy

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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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Fujian provincial hospital

Fuzhou, Fujian, 350001, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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
  • Pregnancy
  • Substance abuse or intake of drugs that affect the central nervous system
  • Inability to communicate in Mandarin Chinese.
  • Illiteracy

Treatment and study plan

0.1 mg/kg esketamine

Drug

Esketamine 0.1 mg/kg was intravenously injected first.

Other names: S-ketamine 0.1 mg/kg

0.2 mg/kg esketamine

Drug

Esketamine 0.2 mg/kg was intravenously injected first.

Other names: S-ketamine 0.2 mg/kg

0.9% saline

Drug

0.9% saline was intravenously injected first.

Other names: Normal saline

Propofol

Drug

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. Postoperative quality of recovery

    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.

  2. Injection pain

    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).

  3. Emergency time

    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.

  4. Incidence of adverse events

    Time frame: Up to 72 h postoperatively

    Episodes of adverse events such as bradycardia, tachycardia, hypotension, hypertension, hypoxia, nausea, vomiting, nightmare, and blurred vision

  5. Propofol consumption

    Time frame: During the bronchoscopy procedure

    Propofol consumption will be recorded during the bronchoscopy procedure.

  6. Patient willingness to repeat the procedure

    Time frame: 24 hours postoperatively

    Patients will be asked whether they would repeat the identical procedural process (Yes/No/Unsure).

  7. Bronchoscopist satisfaction

    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).

  8. Patient satisfaction

    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).

  9. Patient willingness to recommend screening

    Time frame: 24 hours postoperatively

    Patients will be asked whether they would recommend bronchoscopy screening to a friend or a relative (Yes/No/Unsure).

Sponsors and collaborators

Lead sponsor

Fujian Provincial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 8, 2022
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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