Anaesthesia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: In this study, we enrolled: - All patients aged over 18 years and under 80 years who had an indication for bronchoscopy (whether admitted to the hospital or as outpatients), for diagnostic or therapeutic purposes - Patients who provided written consent for the procedure.
Exclusion criteria
Exclusion criteria: The presence of at least one of the following criteria was sufficient to render the patient ineligible for this study: -Age under 18 years -Contraindications to sedation: -History of hypersensitivity to midazolam or ketamine (history of paradoxical reaction or anaphylaxis) -Severe hepatic insufficiency (liver failure) -Severe coronary artery disease or severe heart failure -Obstructive sleep apnea-hypopnea syndrome -Severe chronic respiratory failure -Poorly controlled or complicated hypertension
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome criterion was the procedure success rate, with success defined as adequate analgesia using a Numerical Rating Scale (NRS) pain score (scale from 0 to 10 cm) of less than 4/10 and a light to moderate sedation level with a MOAA/S scale score between 3 and 4. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome criteria were: -The clinical tolerance of patients to conscious sedation (hemodynamic and respiratory tolerance: primarily the number of desaturation events, defined as SpO2 < 90%). -The comfort and satisfaction felt by the physician were measured using a Likert evaluation scale, scored from 1 (highest discomfort) to 5 (maximum perceived comfort). -The occurrence of adverse events related to the administered medications and the potential use of reversal agents. | — |
Countries
Tunisia
Contacts
Dr