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

Phase 4

Completed

• Conditions: Remifentanil; Fentanyl; Sufentanil; Bronchoscopy; Narcotrend; Conscious Sedation
• Interventions: Drug: Sufentanil; Drug: Fentanyl; Drug: Remifentanil; Drug: Midazolam

• Registration Number: NCT03901716
• Lead Sponsor: Guangzhou Institute of Respiratory Disease

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-15
• Primary Completion: 2019-03-15
• Study Completion: 2019-03-26
• Study First Submitted: 2019-03-30
• Status Verified: 2019-04
• Study First Submitted QC: 2019-04-02
• Last Update Submitted: 2019-04-02
• Study First Posted: 2019-04-03
• Last Update Posted: 2019-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sufentanil	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).
Sufentanil	Midazolam	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).
Fentanyl	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).
Fentanyl	Midazolam	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).
Remifentanil	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).
Remifentanil	Midazolam	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).

Primary Outcome Measures

Name	Time	Method
Dosage of midazolam	during the procedure	Dosage of midazolam applied

Secondary Outcome Measures

Name	Time	Method
rate of oxygen desaturation	during the procedure	oxygen desaturation (SaO2 decrease\<90% for \>30 s)
severity of cough	during the procedure	total times of cough
patient's global tolerance assessed by operator	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)
patient's subjective tolerance	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)

Trial Locations

Locations (1)

the First Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China