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

Guangzhou Institute of Respiratory Disease80 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Bronchoscopy

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 69 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Dosage of Midazoam

dosage of midazolam

Time frame: during the procedure

Secondary Outcomes

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)

Time frame: 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)

Time frame: 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).

Time frame: every 3 minutes during the procedure and at 5, 15 and 30 minutes thereafter.