A randomized and controlled study comparing efficacy of intra-operative patient controlled sedation versus radiologist controlled sedation using midazolam and fentanyl, for patients undergoing insertion of a central venous line.
- Conditions
- Radiologically-guided insertion of a central venous line for patients undergoing chemotherapy, dialysis, or other conditions requiring high flow long term central line access (eg treatment of cystic fibrosis or other chronic disease)Anaesthesiology - Anaesthetics
- Registration Number
- ACTRN12615000789561
- Lead Sponsor
- Alfred Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 40
Patients referred to the Radiology Department for elective central venous line insertion (for example, but not limited to: Hickman line for chemotherapy or antibiotics, Portacath for commencement urgent dailysis)
Males and females aged 18 to 75
No allergy to fentanyl and/or midazolam
ASA score 1 to 3
Signed study participant information and Consent form.
Pregnancy
Coagulopathy (INR > 2, platelets < 50)
Abnormal renal function with a calculated e-GFR <40;
Allergy to contrast;
ASA score 4 to 6
Therapeutic heparinisation or current thrombolysis
Sepsis
Cellulitis or dermatitis at planned insertion site
On protease inhibitor antiretroviral drugs
Altered conscious state
Head injury
Significant hepatic dysfunction
Head or neck tumours
Not fasted for at least 4 hours
Contraindication to administration of inspired oxygen
Unable to sign participant information and Consent form
Lacks capacity to provide study consent for self
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method