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

Study Overview
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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.

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

Conditions
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Sufentanil, Remifentanil, Fentanyl, Bronchoscopy, Narcotrend, Conscious Sedation

Intervention / Treatment
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* Drug: Sufentanil
* Drug: Fentanyl
* Drug: Remifentanil
* Drug: Midazolam


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dosage of midazolam | Dosage of midazolam applied | during the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| severity of cough | total times of cough | during the procedure | 
| 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 | 
| 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 | 
| rate of oxygen desaturation | oxygen desaturation (SaO2 decrease<90% for >30 s) | during the procedure |