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Esketamine-propofol Versus Propofol for Flexible Bronchoscopy

NCT05643066 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 246

Last updated 2025-12-22

No results posted yet for this study

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

Interventions

DRUG

0.1 mg/kg esketamine

Esketamine 0.1 mg/kg was intravenously injected first.

DRUG

0.2 mg/kg esketamine

Esketamine 0.2 mg/kg was intravenously injected first.

DRUG

0.9% saline

0.9% saline was intravenously injected first.

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).

Sponsors & Collaborators

  • Fujian Provincial Hospital

    lead OTHER

Principal Investigators

  • Xiaochun Zheng, MD · Fujian Provincial Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-07
Primary Completion
2023-12-18
Completion
2023-12-21

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05643066 on ClinicalTrials.gov