Esketamine-propofol Versus Propofol for Flexible Bronchoscopy

NCT ID: NCT05643066

Last Updated: 2025-12-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 246 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-07
• Study Completion Date: 2023-12-21

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.

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

Keywords

bronchoscopy; esketamine; procedure sedation; propofol

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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).

Group Type: EXPERIMENTAL

0.1 mg/kg esketamine

Intervention Type: DRUG

Esketamine 0.1 mg/kg was intravenously injected first.

Propofol

Intervention Type: 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).

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).

Group Type: EXPERIMENTAL

0.2 mg/kg esketamine

Intervention Type: DRUG

Esketamine 0.2 mg/kg was intravenously injected first.

Propofol

Intervention Type: 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).

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).

Group Type: PLACEBO_COMPARATOR

0.9% saline

Intervention Type: DRUG

0.9% saline was intravenously injected first.

Propofol

Intervention Type: 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).

Interventions

0.1 mg/kg esketamine

Esketamine 0.1 mg/kg was intravenously injected first.

Intervention Type: DRUG

0.2 mg/kg esketamine

Esketamine 0.2 mg/kg was intravenously injected first.

Intervention Type: DRUG

0.9% saline

0.9% saline was intravenously injected first.

Intervention Type: 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).

Intervention Type: DRUG

Other Intervention Names

S-ketamine 0.1 mg/kg; S-ketamine 0.2 mg/kg; Normal saline; propofol injection

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fujian Provincial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yao Yusheng

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiaochun Zheng, MD

Role: STUDY_CHAIR

Fujian Provincial Hospital

Locations

Fujian provincial hospital

Fuzhou, Fujian, China

Countries

China

Other Identifiers

K2021-12-067

Identifier Type: -

Identifier Source: org_study_id