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

Bronchoscopy Clinical Trial

Official title:

Comparison of Sufentanil, Fentanyl and Remifentanil in Combination With Midazolam During Bronchoscopy Under Conscious Sedation: A Randomized Double-blind Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03901716
• Other study ID #: Opioid2019
• Status: Completed
• Phase: Phase 4
• Start date: January 15, 2019
• Est. completion date: March 26, 2019

Study information

• Verified date: April 2019
• Source: Guangzhou Institute of Respiratory Disease
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 26, 2019
• Est. primary completion date: March 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Bronchoscopy
• Conscious Sedation
• Fentanyl
• Narcotrend
• Remifentanil
• Sufentanil

Intervention

Drug:
• Sufentanil
Patients in Group S received sufentanil 0.1 mcg/kg.
• Fentanyl
Patients in Group F received fentanyl 1 mcg/kg.
• Remifentanil
Patients in Group R received remifentanil target-controlled infusion with effect-site target concentration of 1ng/ml.
• Midazolam
Patients in all groups received midazolam to achieve moderate levels of sedation as assessed by the Narcotrend (NT; between B1 and C2).

Locations

Country	Name	City	State
China	the First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou Institute of Respiratory Disease

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dosage of midazolam	Dosage of midazolam applied	during the procedure
Secondary	severity of cough	total times of cough	during the procedure
Secondary	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
Secondary	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
Secondary	rate of oxygen desaturation	oxygen desaturation (SaO2 decrease<90% for >30 s)	during the procedure