NCT04919174

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 364 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

All patients undergoing bronchoscopy under general anesthesia will be recruited and should complete relevant preoperative examinations. The patient fasted for 6-8 hours before the operation, and an indwelling trocar was placed in the vein. After entering the room, the patient will be monitored with electrocardiogram(ECG), pulse oximetry, non-invasive blood pressure, and underwent oxygen inhalation (5L/min) through a nasal cannula. All patients used 2% lidocaine glue to moisten the nasal cavity for local anesthesia before the operation, the bronchoscope was inserted through the nose. The subjects take a supine position. When the bronchoscope passes through the vocal cords and carina, 5 ml of 2% lidocaine is delivered through the channel to suppress the cough reflex. Then the patients were randomly divided into two groups: 1. one group use dexmedetomidine-remifentanil for anesthesia: the initial dose of dexmedetomidine is 0.1ml/kg, infused for 5 minutes, and then adjusted to 0.1-0.5ml/kg/h; the initial dose of remifentanil is 0.05ml/kg, infused for 5 minutes, and then adjusted to 0.1- 0.5 ml/kg/h. 2. the other group use remimazolam-remifentanil for anesthesia: the initial dose of remimazolam is 0.1ml/kg, infused for 5 minutes, and then adjusted to 0.1-0.5ml/kg/h; the initial dose of remifentanil is 0.05ml/kg, infused for 5 minutes, and then adjusted to 0.1- 0.5 ml/kg/h. All patients started bronchoscopy when they reached TE sedation (modified observer's assessment of sedation,MOAA/S score 3 points). If the assessment of sedation after administration suggests that the sedation is insufficient, propofol 0.4-0.6 mg/kg is repeatedly administered every 5 minutes, with the maximum dose not exceeding 200 mg to maintain sedation. In the maintenance phase of sedation, appropriate sedation is pre-defined as a MOAA/S score of 4 or less. The drug was continuously infused until the end of the bronchoscopy, and all patients were transferred to the post-anaesthesia care unit (PACU) for further observation. Data from the DoCare Clinic electronic anesthesia recording system was used in this experiment. Bronchoscopy was performed by the same bronchologist with more than 10 years of experience.

Conditions

• Bronchoscopy
• Sedation

Interventions

Type	Name	Description
DRUG	Remimazolam	Sedation with remimazolam
DRUG	Dexmedetomidine	Sedation with dexmedetomidine

Timeline

• Start date: 2021-04-23
• Primary completion: 2022-04-01
• Completion: 2022-10-01
• First posted: 2021-06-09
• Last updated: 2021-06-09

Locations

1 site across 1 country: China