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

NCT02885948 | Completed Phase 4

• 1 other identifier: UCDCRC/15/006
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Respiratory Depression

Outcome Measures

Primary Outcomes (1)

• Respiratory depression

  within 16 - 24 hours of participation

Secondary Outcomes (4)

• Measure of occurrence of pain

  within 16 - 24 hours of participation

• Requirement for rescue analgesia

  within 16 - 24 hours of participation

• Nausea/Vomiting

  within 16 - 24 hours of participation

• Pruritus

  within 16 - 24 hours of participation

Study Arms (2)

Naloxone

EXPERIMENTAL

The 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.

Drug: Naloxone

Saline

PLACEBO COMPARATOR

The placebo arm of the study will receive an infusion of normal saline at a rate of 0.25ml/kg/hr.

Drug: Placebo

Interventions

Naloxone DRUG

used to block the effects of opioids, especially in overdose

Naloxone

Placebo DRUG

Placebo, ineffective control arm

Also known as: Placebo Saline

Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University College Dublin: lead

Study Sites (1)

Prof. Alistair Nichol

Dublin, Dublin 4, Ireland

Location

Related Publications (2)

• 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.

  PMID: 31792949 DERIVED

• 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.

  PMID: 29284510 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Naloxone

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Peter Doran, PhD

  UCD

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2016
• First Posted: September 1, 2016
• Study Start: April 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: December 19, 2017

Record last verified: 2017-12

Locations

IE (1)