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NCT Number: NCT03738137

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

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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Key information

Conditions

Bronchoscopy

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510000, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Narotrend

Device

Narcotrend motoring

BIS

Device

Bispectral index monitoring

Sufentanil

Drug

sufentanil is applied.

Lidocaine

Drug

Topical Anesthesia

midazolam

Drug

midazolam is applied.

Primary outcomes

  1. Dosage of Midazoam

    Time frame: during the procedure

    dosage of midazolam

Secondary outcomes

  1. patient's subjective tolerance

    Time frame: 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)

  2. patient's global tolerance assessed by operator

    Time frame: 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)

  3. adverse events rate

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Guangzhou Institute of Respiratory Disease

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 13, 2018
Registry last updated
Apr 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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