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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2019-01-30

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.

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Detailed Description

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Conditions

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Bronchoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Narcotrend

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.

Group Type EXPERIMENTAL

Narotrend

Intervention Type DEVICE

Narcotrend motoring

Sufentanil

Intervention Type DRUG

sufentanil is applied.

Lidocaine

Intervention Type DRUG

Topical Anesthesia

Midazolam

Intervention Type DRUG

midazolam is applied.

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).

Group Type EXPERIMENTAL

BIS

Intervention Type DEVICE

Bispectral index monitoring

Sufentanil

Intervention Type DRUG

sufentanil is applied.

Lidocaine

Intervention Type DRUG

Topical Anesthesia

Midazolam

Intervention Type DRUG

midazolam is applied.

No monitoring

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

Group Type EXPERIMENTAL

Sufentanil

Intervention Type DRUG

sufentanil is applied.

Lidocaine

Intervention Type DRUG

Topical Anesthesia

Midazolam

Intervention Type DRUG

midazolam is applied.

Lidocaine

Only topical anesthesia was applied.

Group Type EXPERIMENTAL

Lidocaine

Intervention Type DRUG

Topical Anesthesia

Interventions

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Narotrend

Narcotrend motoring

Intervention Type DEVICE

BIS

Bispectral index monitoring

Intervention Type DEVICE

Sufentanil

sufentanil is applied.

Intervention Type DRUG

Lidocaine

Topical Anesthesia

Intervention Type DRUG

Midazolam

midazolam is applied.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes