Bronchoscopy and Bispectral Index (BIS) - Guided Sedation

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Bronchoscopy is performed on a daily basis for diagnostic and therapeutic purposes. This procedure may cause anxiety and discomfort requiring the use of sedative drugs.

In this study the investigators titrate the administration of sedatives using bispectral analysis of the EEG. The investigators compared 2 drugs, propofol versus midazolam regarding patient subjective tolerance, recovery of brain function, safety and operator's satisfaction.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Hospital, Geneva
• Collaborator: Centre Valaisan de Pneumologie, CH-3960Montana
• Treatments: Midazolam; Propofol

Criteria

Inclusion Criteria:

• patients scheduled for bronchoscopy

• ASA I to III

• age between 18 and 79 years

• capacity of discernment

Exclusion Criteria:

• visual and psychological problems that might interfere with psychometric testing

• chronic obstructive pulmonary disease with FEV1 < 50% predicted

• need for an airway intubation or laryngeal mask insertion

• fever or other signs of systemic infection

• hemodynamic instability defined as a resting heart rate (HR) < 60 or ≥ 120 and/or a systolic blood pressure (BP) < 100 or > 180 mmHg

• significant liver disease and documented soy allergy