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

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

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 Overview

• Status: Completed
• Conditions: Bronchoscopy
• Intervention / Treatment: Device: BIS; Device: Narotrend; Drug: Sufentanil; Drug: Lidocaine; Drug: Midazolam

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • The First Affiliated Hospital of Guangzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Guangzhou Institute of Respiratory Disease

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Actual): January 15, 2019
• Study Completion (Actual): January 30, 2019

Study Registration Dates

• First Submitted: November 1, 2018
• First Submitted That Met QC Criteria: November 9, 2018
• First Posted (Actual): November 13, 2018

Study Record Updates

• Last Update Posted (Actual): April 3, 2019
• Last Update Submitted That Met QC Criteria: April 2, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Bispectral index; Bronchoscopy; Conscious Sedation; Narcotrend
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Midazolam; Lidocaine; Sufentanil
• Other Study ID Numbers: NTBIS2018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No