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

Guangzhou Institute of Respiratory Disease

Status: Completed

Conditions: Bronchoscopy

Treatments: Device: Narotrend; Drug: Midazolam; Drug: Sufentanil; Drug: Lidocaine; Device: BIS

Study type: Interventional

Funder types: Other

Identifiers

NCT03738137

NTBIS2018

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 69 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 4 patient groups

Narcotrend

Experimental group

Description:

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.

Treatment:

Drug: Sufentanil

Drug: Midazolam

Drug: Lidocaine

Device: Narotrend

BIS

Experimental group

Description:

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).

Treatment:

Drug: Sufentanil

Drug: Midazolam

Drug: Lidocaine

Device: BIS

No monitoring

Experimental group

Description:

After 0.1µg/kg sufentanil is applied, midazolam iss given by non-anaesthetist physicians according to patient's tolerance .

Treatment:

Drug: Sufentanil

Drug: Midazolam

Drug: Lidocaine

Lidocaine

Experimental group

Description:

Only topical anesthesia was applied.

Treatment:

Drug: Lidocaine