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

Guangzhou Institute of Respiratory Disease

Status and phase: Completed; Phase 4

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

Treatments: Drug: Remifentanil; Drug: Midazolam; Drug: Sufentanil; Drug: Fentanyl

Study type: Interventional

Funder types: Other

Identifiers

NCT03901716

Opioid2019

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 3 patient groups

Sufentanil

Experimental group

Description:

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).

Treatment:

Drug: Midazolam

Drug: Sufentanil

Fentanyl

Experimental group

Description:

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).

Treatment:

Drug: Midazolam

Drug: Fentanyl

Remifentanil

Experimental group

Description:

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).

Treatment:

Drug: Midazolam

Drug: Remifentanil