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

NCT03901716 | Completed Phase 4 DMC

• 1 other identifier: Opioid2019
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sufentanil; Remifentanil; Fentanyl; Bronchoscopy; Narcotrend; Conscious Sedation

Outcome Measures

Primary Outcomes (1)

• Dosage of midazolam

  Dosage of midazolam applied

  during the procedure

Secondary Outcomes (4)

• severity of cough

  during the procedure

• patient's subjective tolerance

  30minutes after bronchoscopy

• patient's global tolerance assessed by operator

  30minutes after bronchoscopy

• rate of oxygen desaturation

  during the procedure

Study Arms (3)

Sufentanil

EXPERIMENTAL

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).

Drug: Sufentanil; Drug: Midazolam

Fentanyl

EXPERIMENTAL

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).

Drug: Fentanyl; Drug: Midazolam

Remifentanil

EXPERIMENTAL

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).

Drug: Remifentanil; Drug: Midazolam

Interventions

Sufentanil DRUG

Patients in Group S received sufentanil 0.1 mcg/kg.

Sufentanil

Fentanyl DRUG

Patients in Group F received fentanyl 1 mcg/kg.

Fentanyl

Remifentanil DRUG

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

Remifentanil

Midazolam DRUG

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

Fentanyl; Remifentanil; Sufentanil

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA grade I-II

You may not qualify if:

• 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
• asthmatic patients

Sponsors & Collaborators

• Guangzhou Institute of Respiratory Disease: lead

Study Sites (1)

the First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Interventions

Sufentanil; Fentanyl; Remifentanil; Midazolam

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Shiyue Li, Professor

  The First Affiliated Hospital of Guangzhou Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: March 30, 2019
• First Posted: April 3, 2019
• Study Start: January 15, 2019
• Primary Completion: March 15, 2019
• Study Completion: March 26, 2019
• Last Updated: April 3, 2019

Record last verified: 2019-04

Locations

CN (1)