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

Bronchoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03738137
• Other study ID #: NTBIS2018
• Status: Completed
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: January 30, 2019

Study information

• Verified date: April 2019
• Source: Guangzhou Institute of Respiratory Disease
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 30, 2019
• Est. primary completion date: January 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Bronchoscopy

Intervention

Device:
• Narotrend
Narcotrend motoring
• BIS
Bispectral index monitoring

Drug:
• Sufentanil
sufentanil is applied.
• Lidocaine
Topical Anesthesia
• Midazolam
midazolam is applied.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou Institute of Respiratory Disease

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dosage of Midazoam	dosage of midazolam	during the procedure
Secondary	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)	30minutes after bronchoscopy
Secondary	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)	30minutes after bronchoscopy
Secondary	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).	every 3 minutes during the procedure and at 5, 15 and 30 minutes thereafter.