Comparison of Sufentanil, Fentanyl and Remifentanil in Combination With Midazolam During Bronchoscopy Under Conscious Sedation

NCT ID: NCT03901716

Last Updated: 2019-04-03

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

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-15

Study Completion Date

2019-03-26

Brief Summary

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The best opioid for bronchoscopy is still unclear.This randomized double-blind prospective study was conducted on a total of 60 patients who were randomly allocated into 3 groups: Group S received sufentanil 0.1 mcg/kg, Group F received fentanyl 1 mcg/kg and Group R received remifentanil target-controlled infusion with effect-site target concentration of 1ng/ml. Patients in all groups received midazolam to achieve moderate levels of sedation as assessed by the Narcotrend (NT; between B1 and C2). Adverse events, patient tolerance and physician satisfaction were analized.

Detailed Description

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Conditions

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Sufentanil Remifentanil Fentanyl Bronchoscopy Narcotrend Conscious Sedation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Sufentanil

Group S received sufentanil 0.1 mcg/kg and midazolam to achieve moderate levels of sedation as assessed by the Narcotrend (NT; between B1 and C2).

Group Type EXPERIMENTAL

Sufentanil

Intervention Type DRUG

Patients in Group S received sufentanil 0.1 mcg/kg.

Midazolam

Intervention Type DRUG

Patients in all groups received midazolam to achieve moderate levels of sedation as assessed by the Narcotrend (NT; between B1 and C2).

Fentanyl

Group F received fentanyl 1 mcg/kg and midazolam to achieve moderate levels of sedation as assessed by the Narcotrend (NT; between B1 and C2).

Group Type EXPERIMENTAL

Fentanyl

Intervention Type DRUG

Patients in Group F received fentanyl 1 mcg/kg.

Midazolam

Intervention Type DRUG

Patients in all groups received midazolam to achieve moderate levels of sedation as assessed by the Narcotrend (NT; between B1 and C2).

Remifentanil

Group R received remifentanil target-controlled infusion with effect-site target concentration of 1ng/ml and midazolam to achieve moderate levels of sedation as assessed by the Narcotrend (NT; between B1 and C2).

Group Type EXPERIMENTAL

Remifentanil

Intervention Type DRUG

Patients in Group R received remifentanil target-controlled infusion with effect-site target concentration of 1ng/ml.

Midazolam

Intervention Type DRUG

Patients in all groups received midazolam to achieve moderate levels of sedation as assessed by the Narcotrend (NT; between B1 and C2).

Interventions

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Sufentanil

Patients in Group S received sufentanil 0.1 mcg/kg.

Intervention Type DRUG

Fentanyl

Patients in Group F received fentanyl 1 mcg/kg.

Intervention Type DRUG

Remifentanil

Patients in Group R received remifentanil target-controlled infusion with effect-site target concentration of 1ng/ml.

Intervention Type DRUG

Midazolam

Patients in all groups received midazolam to achieve moderate levels of sedation as assessed by the Narcotrend (NT; between B1 and C2).

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
7. asthmatic patients
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangzhou Institute of Respiratory Disease

OTHER

Sponsor Role lead

Responsible Party

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ShiYue Li

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shiyue Li, Professor

Role: STUDY_DIRECTOR

The First Affiliated Hospital of Guangzhou Medical University

Locations

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the First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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Opioid2019

Identifier Type: -

Identifier Source: org_study_id

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