A Randomized Single-blind Clinical Trial of the Efficacy and Safety of Remimazolam in Painless Bronchoscopy

NCT04919174 | Unknown Phase 4 DMC

• 1 other identifier: 2021-0058
• Study Type: interventional
• Target: 364
• Locations: 1 country
• Sites: 1

Brief Summary

Over the past decade, bronchoscopy technology has developed rapidly and has become an important part of the diagnosis and treatment of respiratory diseases. Bronchoscopy are usually carried out under monitored anesthesia care (MAC), which can relieve the anxiety of the patient, make the operation easier, and improve the completion rate of bronchoscopy. At present, bronchoscopy has widely used midazolam, propofol, short-acting opioids, and newer sedatives such as dexmedetomidine, but each drug has its limitations. Dexmedetomidine is widely used in non-intubation general anesthesia and sedation during short outpatient surgery. However, rapid and high-dose infusion of dexmedetomidine leads to dose-dependent hypotension, temporary hypertension, bradycardia, and excessive sedation, causing hemodynamic fluctuations. At the same time, it has slow onset and metabolism. This may be a potential risk for some elderly patients with many underlying diseases and unstable hemodynamics. Remimazolam is an ultra-short-acting benzodiazepine. It has the advantages of short action time, low accumulation, low risk of respiratory depression, and reversibility. We believe that remimazolam can improve the onset time and resuscitation time, to achieve sufficient sedation, improve the success rate of bronchoscopy, while reducing the patient's oxygen saturation drop during the operation, postoperative opioid-related nausea and vomiting, postoperative delirium and other related adverse events. This study is a randomized controlled trial to confirm the above hypothesis.

Conditions

Bronchoscopy; Sedation

Keywords

remimazolam, dexmedetomidine, bronchoscopy, sedation

Outcome Measures

Primary Outcomes (2)

• Incidence of Decreased Oxygen Saturation [ Safety]

  Oxygen Saturation\<90%, more than 30s

  Within 1 hour after the operation

• Interruption Rate of Bronchoscopy [effectiveness]

  the occurrence of body movement or coughing makes the operating physician have to suspend the operation for physical restraint or adding drugs

  Within 1 hour after the operation

Secondary Outcomes (10)

• Blood Pressure

  Within 1 hour after the operation

• Heart Rate

  Within 1 hour after the operation

• Hemodynamic variable

  Within 1 hour after the operation

• Respiratory Rate

  Within 1 hour after the operation

• Anesthesia onset time

  Within 1 hour after the operation

Study Arms (2)

Control group

ACTIVE COMPARATOR

Patients receive dexmedetomidine for sedation

Drug: Dexmedetomidine

Test group

EXPERIMENTAL

Patients receive remimazolam for sedation

Drug: Remimazolam

Interventions

Remimazolam DRUG

Sedation with remimazolam

Also known as: Remifentanil

Test group

Dexmedetomidine DRUG

Sedation with dexmedetomidine

Also known as: Remifentanil

Control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 70 years old.
• Need for bronchoscopy (for example, unexplained cough, hemoptysis, localized wheezing and hoarseness, chest X-ray and/or CT scans suggest abnormalities, examination and evaluation of lungs before surgery, chest trauma, lungs Or bronchial infectious disease).
• ASA classification I-III level.
• BMI≤30kg/m2.
• Women of childbearing age have a negative pregnancy test.
• Before the study, the patients voluntarily signed and dated the informed consent form approved by the institutional review board.

You may not qualify if:

• Patients with known allergies to benzodiazepines, flumazenil, opioids, naloxone or certain drugs.
• Patients with long-term use of benzodiazepines or opioids.
• Patients with a history of drug abuse or alcohol abuse in the past two years.
• Bradycardia (baseline HR \<60bpm) or hypotension (baseline SAP\<100mmHg).
• Asthma or chronic obstructive pulmonary disease(COPD) or FEV1\<1.0L.
• SpO2 \<90% before bronchoscopy.
• Patients who received any study drug within 30 days before screening or less than 7 half-lives of the drug.
• Any patient with cognitive impairment or inability to provide informed consent.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The Second Affiliated Hospital of Zhejiang University Medical College

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Interventions

remimazolam; Remifentanil; Dexmedetomidine

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Imidazoles; Azoles

Study Officials

• Min Yan, MD

  Zhejiang University

  STUDY CHAIR

Central Study Contacts

Min Yan, MD

CONTACT

13757118632; zryanmin@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2021
• First Posted: June 9, 2021
• Study Start: April 23, 2021
• Primary Completion: April 1, 2022
• Study Completion: October 1, 2022
• Last Updated: June 9, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)