Esketamine-propofol Versus Propofol for Flexible Bronchoscopy

NCT05643066 | Completed Phase 4 DMC

• 1 other identifier: K2021-12-067
• Study Type: interventional
• Target: 246
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Recovery

Keywords

bronchoscopy; esketamine; procedure sedation; propofol

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Postoperative quality of recovery

  Baseline, up to 72 hours postoperatively

• Injection pain

  Immediately after administering the study drugs, on average 2 minutes

• Emergency time

  Immediately after the bronchoscopy completely withdrawn, on average 8 minutes

• Incidence of adverse events

  Up to 72 h postoperatively

• Propofol consumption

  During the bronchoscopy procedure

Study Arms (3)

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).

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).

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).

Drug: 0.9% saline; Drug: Propofol

Interventions

0.1 mg/kg esketamine DRUG

Esketamine 0.1 mg/kg was intravenously injected first.

Also known as: S-ketamine 0.1 mg/kg

0.1 mg/kg esketamine group

0.2 mg/kg esketamine DRUG

Esketamine 0.2 mg/kg was intravenously injected first.

Also known as: S-ketamine 0.2 mg/kg

0.2 mg/kg esketamine group

0.9% saline DRUG

0.9% saline was intravenously injected first.

Also known as: Normal saline

Placebo group

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).

Also known as: propofol injection

0.1 mg/kg esketamine group; 0.2 mg/kg esketamine group; Placebo group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fujian Provincial Hospital: lead

Study Sites (1)

Fujian provincial hospital

Fuzhou, Fujian, 350001, China

Location

MeSH Terms

Interventions

Esketamine; Saline Solution; Propofol

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Xiaochun Zheng, MD

  Fujian Provincial Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: November 14, 2022
• First Posted: December 8, 2022
• Study Start: December 7, 2022
• Primary Completion: December 18, 2023
• Study Completion: December 21, 2023
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: We would like to share our individual deidentified participant data beginning three months following the publication of the main results.
• 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.

Locations

CN (1)