Narcotrend Versus Bispectral Index Monitoring During Sufentanil-Midazolam Anesthesia for Bronchoscopy

Narcotrend Versus Bispectral Index Monitoring During Sufentanil-Midazolam Anesthesia for Bronchoscopy Under Conscious Sedation

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03738137

Enrollment

Registered

2018-11-13

Start date

2018-08-01

Completion date

2019-01-30

Last updated

2019-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchoscopy

Keywords

Narcotrend, Bispectral index, Bronchoscopy, Conscious Sedation

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.

Interventions

DEVICENarotrend

Narcotrend motoring

DEVICEBIS

Bispectral index monitoring

DRUGSufentanil

sufentanil is applied.

DRUGLidocaine

Topical Anesthesia

DRUGMidazolam

midazolam is applied.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to 69 Years

Healthy volunteers

Yes

Inclusion criteria

ASA grade I-II

Exclusion criteria

1. psychological disorders 2. SpO2\<90% in ambient air 3. hypersensitivity or allergy to anaesthetic drugs or benzodiazepine 4. severe chronic obstructive pulmonary disease (forced expiratory volume in 1 s ,50% of predicted value, requirement for oxygen therapy) 5. unstable haemodynamic status 6. habitual alcohol consumption

Design outcomes

Primary

Measure	Time frame	Description
Dosage of Midazoam	during the procedure	dosage of midazolam

Secondary

Measure	Time frame	Description
patient's subjective tolerance	30minutes after bronchoscopy	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)
patient's global tolerance assessed by operator	30minutes after bronchoscopy	the global tolerance of patient to the procedure using a visual analogic scale (VAS: 1 mm: excellent tolerance, 100 mm very low tolerance)
adverse events rate	every 3 minutes during the procedure and at 5, 15 and 30 minutes thereafter.	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).

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026