Narcotrend Versus Bispectral Index Monitoring During Sufentanil-Midazolam Anesthesia for Bronchoscopy
1 other identifier
interventional
80
1 country
1
Brief Summary
This study was aimed to determine whether narcotrend monitoring was better than bispectral index monitoring during sufentanil-midazolam anesthesia for bronchoscopy under conscious sedation. Patients were randomised to receive Narcotrend, Bispectral Index(BIS) monitoring or without monitoring. Midazolam was given by non-anaesthetist physicians to achieve moderate levels of sedation as assessed by the narcotrend index (NI; B and C) or bispectral index (BIS; between 70 and 85) or according to patient's tolerance assessed by physician . The primary end-point was dosage of midazolam. Other end-points included adverse events, patient tolerance and physician satisfaction.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2018
CompletedFirst Submitted
Initial submission to the registry
November 1, 2018
CompletedFirst Posted
Study publicly available on registry
November 13, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2019
CompletedApril 3, 2019
April 1, 2019
6 months
November 1, 2018
April 2, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Dosage of Midazoam
dosage of midazolam
during the procedure
Secondary Outcomes (3)
patient's subjective tolerance
30minutes after bronchoscopy
patient's global tolerance assessed by operator
30minutes after bronchoscopy
adverse events rate
every 3 minutes during the procedure and at 5, 15 and 30 minutes thereafter.
Study Arms (4)
Narcotrend
EXPERIMENTALAfter 0.1µg/kg sufentanil is applied, miidazolam is given by non-anaesthetist physicians to achieve moderate levels of sedation as assessed by the Narcotrend index stage C.
BIS
EXPERIMENTALAfter 0.1µg/kg sufentanil is applied, midazolam is given by non-anaesthetist physicians to achieve moderate levels of sedation as assessed by bispectral index (BIS; between 70 and 85).
No monitoring
EXPERIMENTALAfter 0.1µg/kg sufentanil is applied, midazolam iss given by non-anaesthetist physicians according to patient's tolerance .
Lidocaine
EXPERIMENTALOnly topical anesthesia was applied.
Interventions
Eligibility Criteria
You may qualify if:
- ASA grade I-II
You may not qualify if:
- psychological disorders
- SpO2\<90% in ambient air
- hypersensitivity or allergy to anaesthetic drugs or benzodiazepine
- severe chronic obstructive pulmonary disease (forced expiratory volume in 1 s ,50% of predicted value, requirement for oxygen therapy)
- unstable haemodynamic status
- habitual alcohol consumption
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510000, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 1, 2018
First Posted
November 13, 2018
Study Start
August 1, 2018
Primary Completion
January 15, 2019
Study Completion
January 30, 2019
Last Updated
April 3, 2019
Record last verified: 2019-04