BronchoscopyNCT03738137
Narcotrend Versus Bispectral Index Monitoring During Sufentanil-Midazolam Anesthesia for Bronchoscopy
A study testing Narotrend, BIS and Sufentanil in people with Bronchoscopy, run by Guangzhou Institute of Respiratory Disease at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Bronchoscopy
- What is being tested?
- Narotrend, BIS and Sufentanil
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2018to 30 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA grade I-II
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510000
About this study
Official title: Narcotrend Versus Bispectral Index Monitoring During Sufentanil-Midazolam Anesthesia for Bronchoscopy Under Conscious Sedation
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.
- Conditions
- Bronchoscopy
- Keywords
- Narcotrend, Bispectral index, Bronchoscopy, Conscious Sedation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NarotrendDevice
Narcotrend motoring
BISDevice
Bispectral index monitoring
SufentanilDrug
sufentanil is applied.
LidocaineDrug
Topical Anesthesia
MidazolamDrug
midazolam is applied.
| Study group | Role | What they receive |
|---|---|---|
| Narcotrend | Experimental | After 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. Receives: Device: Narotrend; Drug: Sufentanil; Drug: Lidocaine; Drug: Midazolam |
| BIS | Experimental | After 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). Receives: Device: BIS; Drug: Sufentanil; Drug: Lidocaine; Drug: Midazolam |
| No monitoring | Experimental | After 0.1µg/kg sufentanil is applied, midazolam iss given by non-anaesthetist physicians according to patient's tolerance . Receives: Drug: Sufentanil; Drug: Lidocaine; Drug: Midazolam |
| Lidocaine | Experimental | Only topical anesthesia was applied. Receives: Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dosage of Midazoam
dosage of midazolam
Measured: during the procedure
Secondary outcomes (3)
patient's subjective tolerance
the intensity of four key symptoms during bronchoscopy (pain, nausea, breathlessness and cough) and memory using a visual analogic scale (VAS: 1 mm: excellent tolerance, 100 mm very low tolerance)
Measured: 30minutes after bronchoscopy
patient's global tolerance assessed by operator
the global tolerance of patient to the procedure using a visual analogic scale (VAS: 1 mm: excellent tolerance, 100 mm very low tolerance)
Measured: 30minutes after bronchoscopy
adverse events rate
hypotension (systolic BP <100 mmHg or mean arterial blood pressure (MAP)<60 mmHg), tachycardia (fC>100/min and/or a variation of >20% from baseline value), oxygen desaturation (SaO2 decrease<90% for >30 s), bradycardia (HR<50/min).
Measured: every 3 minutes during the procedure and at 5, 15 and 30 minutes thereafter.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study start1 Aug 2018
- Primary completion15 Jan 2019
- Study completion30 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou Institute of Respiratory Disease
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ShiYue Li, Guangzhou Institute of Respiratory Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03738137
- Sponsor's protocol ID
- NTBIS2018
- Status last verified
- Apr 2019
- First submitted
- 1 Nov 2018
- Last updated
- 3 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Narcotrend Versus Bispectral Index Monitoring During Sufentanil-Midazolam Anesthesia for Bronchoscopy Under Conscious Sedation
- ClinicalTrials.gov ID
- NCT03738137
- Acronym / sponsor ID
- NTBIS2018
- Conditions
- Bronchoscopy
- Keywords
- Narcotrend, Bispectral index, Bronchoscopy, Conscious Sedation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Guangzhou Institute of Respiratory DiseaseUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 15 Jan 2019 (actual)
- Study completion
- 30 Jan 2019 (actual)
- First posted
- 13 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Narcotrend | Experimental | Device: Narotrend, Drug: Sufentanil, Drug: Lidocaine, Drug: MidazolamAfter 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 | Experimental | Device: BIS, Drug: Sufentanil, Drug: Lidocaine, Drug: MidazolamAfter 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 | Experimental | Drug: Sufentanil, Drug: Lidocaine, Drug: MidazolamAfter 0.1µg/kg sufentanil is applied, midazolam iss given by non-anaesthetist physicians according to patient's tolerance . |
| Lidocaine | Experimental | Drug: LidocaineOnly topical anesthesia was applied. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA grade I-II
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NarotrendNarcotrend motoring | Device | Narcotrend |
| BISBispectral index monitoring | Device | BIS |
| Sufentanilsufentanil is applied. | Drug | BIS, Narcotrend, No monitoring |
| LidocaineTopical Anesthesia | Drug | BIS, Lidocaine, Narcotrend, No monitoring |
| Midazolammidazolam is applied. | Drug | BIS, Narcotrend, No monitoring |
Primary outcome
Dosage of Midazoam
Time frame: during the procedure
dosage of midazolam
3 secondary outcomes
patient's subjective tolerance
Time frame: 30minutes after bronchoscopy
patient's global tolerance assessed by operator
Time frame: 30minutes after bronchoscopy
adverse events rate
Time frame: every 3 minutes during the procedure and at 5, 15 and 30 minutes thereafter.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2019.
Related trials for Bronchoscopy
RecruitingObservational study
Collection of Lung Fluid and Tissue Samples for Research
Leukocyte Disorders, Respiratory Tract Diseases
Recruiting
Clinical Effects of Different Ventilation Strategies in Rigid Bronchoscopy Procedures
Rigid Bronchoscopy Ventilation
Active, not recruitingObservational study
Dexmedetomidine Nasal Spray and Postoperative Sore Throat After Bronchoscopy
Postoperative Sore Throat, Bronchoscopy
Recruiting
Randomized Controlled Trial of Multi-Patient CT-Derived Digital Twin Anatomical Variability Training to Shorten the Clinical Learning Curve for Bronchoscopy
Bronchoscopy, Learning Curves and Outcomes of Simulation-based Training
Not yet recruitingObservational study
Feasibility and Preliminary Performance of an AI Prototype for Digital ROSE During EBUS-TBNA and Peripheral TBNA: a Prospective Pilot Study (AI-ROSE-FEAS)
Lung Neoplasms, Bronchoscopy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Narotrend, BIS and Sufentanil in people with Bronchoscopy, run by Guangzhou Institute of Respiratory Disease at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dosage of Midazoam (time frame: during the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2019; AzTrials last refreshed its copy on 8 Nov 2026.