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

Not Applicable

Completed

• Conditions: Bronchoscopy
• Interventions: Device: BIS; Device: Narotrend; Drug: Sufentanil; Drug: Lidocaine; Drug: Midazolam

• Registration Number: NCT03738137
• Lead Sponsor: Guangzhou Institute of Respiratory Disease

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-01
• Study First Submitted: 2018-11-01
• Study First Submitted QC: 2018-11-09
• Study First Posted: 2018-11-13
• Primary Completion: 2019-01-15
• Study Completion: 2019-01-30
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-02
• Last Update Posted: 2019-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BIS	BIS	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).
Narcotrend	Narotrend	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.
Narcotrend	Midazolam	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.
BIS	Sufentanil	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).
Narcotrend	Lidocaine	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.
Narcotrend	Sufentanil	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.
No monitoring	Sufentanil	After 0.1µg/kg sufentanil is applied, midazolam iss given by non-anaesthetist physicians according to patient's tolerance .
BIS	Lidocaine	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).
BIS	Midazolam	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).
No monitoring	Lidocaine	After 0.1µg/kg sufentanil is applied, midazolam iss given by non-anaesthetist physicians according to patient's tolerance .
No monitoring	Midazolam	After 0.1µg/kg sufentanil is applied, midazolam iss given by non-anaesthetist physicians according to patient's tolerance .
Lidocaine	Lidocaine	Only topical anesthesia was applied.

Primary Outcome Measures

Name	Time	Method
Dosage of Midazoam	during the procedure	dosage of midazolam

Secondary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

The First Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China