Safety and Efficacy of Sufentanil Combined With Midazolam in Bronchoscopy Under Conscious Sedation: Retrospective Study

NCT03890094 | Completed DMC FDA Drug

• 1 other identifier: Suretro2013
• Study Type: observational
• Target: 11,158
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to determine the safety and efficacy of sufentanil combined with midazolam in bronchoscopy under conscious sedation. A retrospective analysis was conducted on all patients undergoing bronchoscopy applying sufentanil and midazolam under conscious sedation in the First Affiliated Hospital of Guangzhou Medical University from September 2013 to July 2017.

Conditions

Bronchoscopy; Sedation

Keywords

Sufentanil; Bronchoscopy; Conscious sedation; midazolam

Outcome Measures

Primary Outcomes (1)

• Oxygen desaturation

  Percentage of patients whose oxygen saturation decreased to lower than 80% during procedure

  during the procedure

Study Arms (1)

Sufentanil and Midazolam

Patients who had undergone bronchoscopy applying topical lidocaine, sufentanil and midazolam under conscious sedation in the First Affiliated Hospital of Guangzhou Medical University from September 2013 to July 2017 were included in this study.

Drug: Sufentanil

Interventions

Sufentanil DRUG

Patients were applied sufentanil and midazolam intravenously and topical anesthetized.

Sufentanil and Midazolam

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

According to guidelines of bronchoscopy, patients had no food by mouth for 4h and to allow clear fluids by mouth up to 2 h before bronchoscopy. Oxygen supplementation was given to the patients through the nasal cannula (2-5L/min, adjusted as needed). 2% lidocaine was applied for topical anesthesia. Sufentanil and midazolam were applied intravenously.

You may qualify if:

• Patients who had undergone bronchoscopy applying topical lidocaine, sufentanil and midazolam under conscious sedation in the First Affiliated Hospital of Guangzhou Medical University from September 2013 to July 2017

You may not qualify if:

• Patients who had undergone bronchoscopy not applying topical lidocaine, sufentanil and midazolam under conscious sedation

Sponsors & Collaborators

• Guangzhou Institute of Respiratory Disease: lead

Study Sites (1)

The Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Interventions

Sufentanil

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Shiyue Li, Professor

  The First Affiliated Hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: March 24, 2019
• First Posted: March 26, 2019
• Study Start: January 1, 2018
• Primary Completion: March 30, 2018
• Study Completion: May 30, 2018
• Last Updated: April 2, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)