CompletedPhase 4ACTRN12621000358842

A Comparison of patient assessment of comfort, comparing bronchoscopy with conscious sedation or anaesthetist controlled sedation; a randomised prospective trial.

Comparison of comfort scores comparing bronchoscopy with conscious sedation or anaesthetist controlled sedation; a randomised prospective trial.


Sponsor

Royal Brisbane and Womens Hospital - Department of Thoracic Medicine

Enrollment

90 participants

Start Date

Oct 30, 2013

Study Type

Interventional

Conditions

Summary

As part of any bronchoscopic procedure, patients are administered sedation. This is in order to make the procedure as comfortable as possible for them, as well as making the procedure technically easier by reducing movement and suppressing cough. We currently use two methods of sedation: 1) Conscious Sedation: this is the use of 2 medications (Midazolam and Fentanyl); administered by one of the treating doctors, whilst the other doctor performs the bronchoscopy. The dose of medication is adjusted to the desired effect during the procedure. The effect is that the patient will be in a sleep like state, whilst still breathing, but with a poor recollection of events once the effect has resolved. 2) Anaesthetist Controlled Anaesthetic: This involves the use of general anaesthetic agents to induce a state of unconsciousness. In most instances this will require the use of an airway device (Laryngeal mask airway or endotracheal tube) to ensure the airway stays open and there is clear flow of oxygen to the lungs. This anaesthesia is given by an Anaesthetist whilst the treating doctor performs the bronchoscopy. Currently the method of sedation is determined by the treating doctor and generally depends on the technical difficulty of the procedure as well as the likelihood of the patient coughing. General anaesthesia being favoured for these cases. In the majority of cases the mode of sedation is decided upon by chance. As we have 2 conscious sedation lists a week and 2 anaesthetic lists per week, whichever list the patient fits into will decide the mode of sedation. Neither of these methods has been shown to be more effective, or shown to be safer than the other. Information regarding patient comfort and satisfaction with either sedation technique has not been collected. We aim to assess comfort and satisfaction during the procedure, so we can determine which is the more favourable for patients, when we offer it in the future. We plan a randomised prospective cohort comparison survey of patients undergoing sedation for a bronchoscopic procedure. Two groups will be compared. Those undergoing conscious sedation versus those undergoing anaesthetist controlled sedation. Patients in both groups will be undergoing both therapeutic and diagnostic procedures. Data collection would involve a short survey prior to the procedure to get an idea of patient expectations, as well as a survey 24-48 hours following the procedure (when the sedation has worn off), to get an idea of what the experience was like. This would involve a phone call from the treating doctor. Other secondary endpoints such as complications and medical staff perception of sedation will also be assessed. In no way will this impact on the procedure the patient would otherwise be having.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria1

  • Patients requiring bronchoscopy for medical reason

Exclusion Criteria1

  • Those <18 years of age, pregnant women, those with an artificial airway such as tracheostomy, significant allergy demanding specific anaesthetic and those unable to give accurate information regarding their experience (i.e. those lacking mental capacity).

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Interventions

The intervention arm are to be given Conscious Sedation by: a) Using a combination of Fentanyl and Midazolam b) The doses of these medications where given at the discretion of the proceduralist up t

The intervention arm are to be given Conscious Sedation by: a) Using a combination of Fentanyl and Midazolam b) The doses of these medications where given at the discretion of the proceduralist up to a maximum of 100ug and 5mg respectively. c) Medications were administered intravenously. d) Medications were given at the commencement of the procedure, and additional amounts where given, up to the maximum, at the discretion of the proceduralist to maintain adequate comfort during the procedure. e) The required medication amount was logged within the Anaesthetic record.


Locations(1)

Royal Brisbane & Womens Hospital - Herston

QLD, Australia

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ACTRN12621000358842