A pilot study assessing the effectiveness and safety of patient-controlled sedation during the insertion of a central venous line.

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12614001280695
• Date of registration: 05/12/2014
• Prospective Registration: Yes
• Primary sponsor: Alfred Hospital
• Public title: A pilot study assessing the effectiveness and safety of patient-controlled sedation during the insertion of a central venous line.
• Scientific title: A pilot study assessing the use of intra-operative, patient-controlled sedation with midazolam and fentanyl for patients undergoing insertion of a central venous line.
• Date of first enrolment: 15/12/2014
• Target sample size: 10
• Recruitment status: Not yet recruiting
• URL: https://anzctr.org.au/ACTRN12614001280695.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Safety/efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Dr Helen Kavnoudias

• Name: Dr Helen Kavnoudias

Key inclusion & exclusion criteria

Inclusion criteria: 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.
Exclusion criteria: 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


Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

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);
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 - Other anaesthesiology

Intervention(s)

To conduct a pilot study to assess intra-operative, patient–controlled sedation with midazolam and fentanyl for patients undergoing insertion of a central venous line.

This practice will allow the patient to self-administer a controlled dose of sedation/analgesia which then has a lock-out period. This will be done using a standard hospital patient controlled analgesia (PCA) pump which are in wide use in postoperative patients.

The intervention will allow patient's access to the PCA device from the beginning of the procedure (after 'time out' has been done) until the procedure finishes and the drapes are removed. Each button press will deliver a dose of 1 mg midazolam and 25 micrograms fentanyl. This will have a 3 minute lockout interval. Patient's will be instructed as to the way to use the device.

This practice will help to allow better control of sedation and potentially reduce the risk of underdosing and overdosing.

This pilot study will allow us to prove that the theory works (as has been shown in the literature) and to optimise the equipment and dosing in preparation for a larger RCT.

Primary Outcome(s)

Patient satisfaction with procedure and quality of recovery measured with the postoperative Alfred Quality of Recovery Tool and the 10 point VAS Patient Satisfaction Survey [Measured at 2 hours post the procedure]

Success of sedation and analgesia measured by the Victorian Standard Sedation Score and Ramsay Sedation Score[Measured at selected time points during the procedure and immediately after the procedure:
Time 1 - Pre-procedure
Time 2 - After time out the procedure begins and the PCA is active
Time 3 - Prep and drape
Time 4 - Local anaesthetic
Time 5 - During the 'tunneling' process of the ventral line procedure
Time 6 - End of procedure - drapes removed, PCA removed]

Patient duration of amnesia for specified stimuli during the procedure, measured by questioning patients about the stimuli 1 hour after the procedure[1 hour after the procedure]

Secondary Outcome(s)

Safety assessed by the composite number of procedural, pre-discharge and 24 hour adverse events measured by Common Terminology Criteria for Adverse Events v4
Possible adverse effects include:
1 - undersedation (this is common but less likely to occur with this patient-controlled technique)
2 - overdosing (also unlikely to occur as patient will be sedation and unable to activate PCA button)
3 - paradoxical effects of sedation - transient disinhibition sometimes seen during light sedation
4 - hypotension - uncommon response to midzazolam and usually asymptomatic given the patient will be supine for the procedure[Recorded at discharge (2 hrs after procedure)]

Numbers and timing of PCS button requests that are not successful, ie during the administration of a prior successful request: these unsuccessful requests are a measure of patient demand for sedation and therefore underdosing[After the procedure]

Time to suitability for discharge at 2 hours post procedure, measured by the Modified Post Anaesthesia Discharge Scoring System (MPADSS)[2 hours post procedure]

Cumulative dose of midazolam and fentanyl measured by reference to the PCA system[Immediately after]

Level of intra-operative pain measured every 10 minutes and level of pain at the end of the procedure measured with the Victorian Acute Pain Management Measurement Toolkit[Every 10 minutes during procedure and after]

Secondary ID(s)

Nil

Source(s) of Monetary Support

N/A

Ethics review

Status: Approved
Approval date:
Contact:

Alfred Hospital Human Research and Ethics Committee