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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03890094
Recruitment Status : Completed
First Posted : March 26, 2019
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
ShiYue Li, Guangzhou Institute of Respiratory Disease

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.

Condition or disease Intervention/treatment
Bronchoscopy Sedation Drug: Sufentanil

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Study Type : Observational
Actual Enrollment : 11158 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Safety and Efficacy of Sufentanil Combined With Midazolam in Bronchoscopy Under Conscious Sedation: Retrospective Study
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : March 30, 2018
Actual Study Completion Date : May 30, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
Patients were applied sufentanil and midazolam intravenously and topical anesthetized.




Primary Outcome Measures :
  1. Oxygen desaturation [ Time Frame: during the procedure ]
    Percentage of patients whose oxygen saturation decreased to lower than 80% during procedure



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03890094


Locations
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China, Guangdong
The Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510000
Sponsors and Collaborators
Guangzhou Institute of Respiratory Disease
Investigators
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Principal Investigator: Shiyue Li, Professor The First Affiliated Hospital of Guangzhou Medical University
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Responsible Party: ShiYue Li, Clinical Professor, Guangzhou Institute of Respiratory Disease
ClinicalTrials.gov Identifier: NCT03890094    
Other Study ID Numbers: Suretro2013
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by ShiYue Li, Guangzhou Institute of Respiratory Disease:
Sufentanil
Bronchoscopy
Conscious sedation
midazolam
Additional relevant MeSH terms:
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Sufentanil
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics