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

Sponsor

Guangzhou Institute of Respiratory Disease (Other)

Overall Status

Completed

CT.gov ID

NCT03901716

Collaborator

(none)

Enrollment

Location

Arms

2.3

Actual Duration (Months)

26.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sufentanil Remifentanil Fentanyl Bronchoscopy Narcotrend Conscious Sedation	Drug: Sufentanil Drug: Fentanyl Drug: Remifentanil Drug: Midazolam	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Jan 15, 2019

Actual Primary Completion Date :

Mar 15, 2019

Actual Study Completion Date :

Mar 26, 2019

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: 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).

Drug: Sufentanil

Patients in Group S received sufentanil 0.1 mcg/kg.

Drug: Midazolam

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

Experimental: 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).

Drug: Fentanyl

Patients in Group F received fentanyl 1 mcg/kg.

Drug: Midazolam

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

Experimental: 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).

Drug: Remifentanil

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

Drug: Midazolam

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

Outcome Measures

Primary Outcome Measures

Dosage of midazolam [during the procedure]
Dosage of midazolam applied

Secondary Outcome Measures

severity of cough [during the procedure]
total times of cough
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)
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)
rate of oxygen desaturation [during the procedure]
oxygen desaturation (SaO2 decrease<90% for >30 s)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

ASA grade I-II

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	the First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong	China	510000

Sponsors and Collaborators

Guangzhou Institute of Respiratory Disease

Investigators

Study Director: Shiyue Li, Professor, The First Affiliated Hospital of Guangzhou Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

ShiYue Li, Clinical Professor, Guangzhou Institute of Respiratory Disease

ClinicalTrials.gov Identifier:

NCT03901716

Other Study ID Numbers:

Opioid2019

First Posted:

Apr 3, 2019

Last Update Posted:

Apr 3, 2019

Last Verified:

Apr 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 3, 2019