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

Study Overview
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Brief Summary
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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.

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

Conditions
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Bronchoscopy

Intervention / Treatment
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* Device: Narotrend
* Device: BIS
* Drug: Sufentanil
* Drug: Lidocaine
* Drug: Midazolam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA grade I-II Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Narcotrend<br>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. | Device: Narotrend<br>* Narcotrend motoring<br>Drug: Sufentanil<br>* sufentanil is applied.<br>Drug: Lidocaine<br>* Topical Anesthesia<br>Drug: Midazolam<br>* midazolam is applied.<br>|
| Experimental: BIS<br>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). | Device: BIS<br>* Bispectral index monitoring<br>Drug: Sufentanil<br>* sufentanil is applied.<br>Drug: Lidocaine<br>* Topical Anesthesia<br>Drug: Midazolam<br>* midazolam is applied.<br>|
| Experimental: No monitoring<br>After 0.1µg/kg sufentanil is applied, midazolam iss given by non-anaesthetist physicians according to patient's tolerance . | Drug: Sufentanil<br>* sufentanil is applied.<br>Drug: Lidocaine<br>* Topical Anesthesia<br>Drug: Midazolam<br>* midazolam is applied.<br>|
| Experimental: Lidocaine<br>Only topical anesthesia was applied. | Drug: Lidocaine<br>* Topical Anesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dosage of Midazoam | dosage of midazolam | during the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Narcotrend, Bispectral index, Bronchoscopy, Conscious Sedation