AzTrials
AzTrials

Respiratory DepressionPhase 4NAPRESSIMNCT02885948

The Use of Low Dose Prophylactic Naloxone Infusion to Prevent Respiratory Depression With Intrathecal Morphine.

A Phase 4 study testing Naloxone in people with Respiratory Depression, run by University College Dublin at 1 site in Ireland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is an investigator led, randomised, double blind, placebo controlled, double arm comparator study. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Respiratory Depression
What is being tested?
Naloxone
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
96 participants
Where
1 siteIreland
Study dates
Apr 2016to Dec 2017
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must be aged 18 years or above at baseline
  • Diagnosed with any hepatobiliary condition requiring an elective major surgical resection under general anaesthetic.
  • Subjects must be able and willing to give written informed consent and to comply with the requirements of this study protocol

Who cannot join

  • Allergy/sensitivity to naloxone
  • Female subjects who are pregnant or breast-feeding.
  • Subjects who have received any other investigational agent within 2 months
  • Subjects taking anticonvulsant medications for epilepsy
  • Subjects who have a cardiac arrhythmia with an uncontrolled rate
  • Subjects who have a history of chronic opioid use / chronic pain
Show all 9Show fewer
  • Any contraindication to intrathecal injection eg coagulopathy
  • Documented history of obstructive sleep apnoea
  • Treating clinician feels not in the patients best interests to be randomised

Trial locations and contacts

1 site in 1 country.

Ireland1 site

  • Prof. Alistair Nichol

    Dublin, Dublin 4

Other trials in Ireland

About this study

Official title: The NAPRESSIM Trial. The Use of Low Dose Prophylactic Naloxone Infusion to Prevent Respiratory Depression With Intrathecal Morphine.

This is an investigator led, randomised, double blind, placebo controlled, double arm comparator study.

Read the detailed description

Delayed respiratory depression is a well-documented side effect associated with the use of intrathecal morphine. This respiratory depression has implications for patient safety and necessitates either the observation of the patient in a high dependency setting for at least 24 hours or the use of an alternative analgesic technique. Other associated side effects include pruritus, nausea and vomiting and sedation. Naloxone is the most effective treatment for these side effects. However, it is usually given as a reactive treatment when the side effect presents.

The hypothesis is that patients who are commenced on a naloxone infusion at low dose early after injection of intrathecal morphine will have a clinically significant reduction in incidence of these side effects. The primary endpoint is a reduction in respiratory depression.

Being tested
Naloxone, Placebo
Medical subject headings
Respiratory Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NaloxoneDrug

    used to block the effects of opioids, especially in overdose

  • PlaceboDrug

    Also called Placebo Saline

    Placebo, ineffective control arm

Study groups in NCT02885948
Study groupRoleWhat they receive
NaloxoneExperimentalThe naloxone arm of the study will receive naloxone at a rate of 5mcg/kg/hr which equates to 0.25ml/kg/hr. Each 1 ml ampoule of solution contains 400 micrograms (0.4mg) naloxone hydrochloride present as naloxone hydrochloride dihydrate. Excipients: each 1ml contains 3.55mg sodium. This will be diluted to a concentration of 20mcg/ml with 0.9% NaCl. Presented as solution for injection or infusion. Clear colourless sterile solution.
Receives: Drug: Naloxone
SalinePlacebo comparatorThe placebo arm of the study will receive an infusion of normal saline at a rate of 0.25ml/kg/hr.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Respiratory depression

    Measured: within 16 - 24 hours of participation

Secondary outcomes (4)

  1. Measure of occurrence of pain

    Measured: within 16 - 24 hours of participation

  2. Requirement for rescue analgesia

    Measured: within 16 - 24 hours of participation

  3. Nausea/Vomiting

    Measured: within 16 - 24 hours of participation

  4. Pruritus

    Measured: within 16 - 24 hours of participation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2016 (estimated)
  2. Study startApr 2016
  3. Primary completionDec 2017
  4. Study completionDec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
96 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02885948
Sponsor's protocol ID
UCDCRC/15/006
Acronym
NAPRESSIM
Status last verified
Dec 2017
First submitted
4 Jul 2016
Last updated
19 Dec 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Cosgrave D, Vencken S, Galligan M, McGuinness S, Soukhin E, McMullan V, Nair S, Puttappa A, Boylan J, Hussain R, Conlon N, Doran P, Nichol A. The effect of a low-dose naloxone infusion on the incidence of respiratory depression after intrathecal morphine administration for major open hepatobiliary surgery: a randomised controlled trial. Anaesthesia. 2020 Jun;75(6):747-755. doi: 10.1111/anae.14931. Epub 2019 Dec 2.

    PubMed 31792949

  • Cosgrave D, Galligan M, Soukhin E, McMullan V, McGuinness S, Puttappa A, Conlon N, Boylan J, Hussain R, Doran P, Nichol A. The NAPRESSIM trial: the use of low-dose, prophylactic naloxone infusion to prevent respiratory depression with intrathecally administered morphine in elective hepatobiliary surgery: a study protocol and statistical analysis plan for a randomised controlled trial. Trials. 2017 Dec 29;18(1):633. doi: 10.1186/s13063-017-2370-0.

    PubMed 29284510

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Naloxone in people with Respiratory Depression, run by University College Dublin at 1 site in Ireland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Respiratory depression (time frame: within 16 - 24 hours of participation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02885948, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in