The use of naloxone to prevent hypoventilation.

The NAPRESSIM trial. The use of low dose prophylactic naloxone infusion to prevent respiratory depression with intrathecal morphine.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-003504-22-IE

Enrollment

Registered

2015-08-18

Start date

2015-10-09

Completion date

Unknown

Last updated

2019-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Depression MedDRA version: 20.0 Level: PT Classification code 10038678 Term: Respiratory depression System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Trade Name: Naloxone Hydrochloride 400 micrograms/ml Solution for Injection or Infusion Product Name: Naloxone Hydrochloride Pharmaceutical Form: Solution for infusion INN or Proposed INN: Naloxone H

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Patients >18 years of age • Capable of giving informed consent. • Undergoing elective open hepatic resection, pancreatectomy or partial pancreatectomy, or other open major hepatobiliary surgery in St Vincents University Hospital. • Consenting to standard anaesthetic and analgesic regimen in the hepatobiliary unit. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 67 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 17

Exclusion criteria

Exclusion criteria: • Chronic opioid use • Pregnancy • <18 years of age • Major Psychiatric illness • Epilepsy with recent seizures • Personal history of adverse reaction to naloxone or any of its derivatives • Contraindication to neuraxial injection • Obstructive sleep apnoea

Design outcomes

Primary

Measure	Time frame
Timepoint(s) of evaluation of this end point: Respiratory depression will be diagnosed based on a composite clinical opinion based on a set of criteria which incorporates some of the clinical criteria used and the ASA prevention of respiratory depression guidance document. - Respiratory rate < 10 / min - SpO2 < 92% or an increase in supplemental O2 Arterial blood gases will be taken 2 hourly while patients are in PACU / HDU and assessed on site as is standard practice. ;Main Objective: A reduction in the incidence of respiratory depression in patients who have received intrathecal morphine as part of their analgesic regimen for major hepatobiliary surgery. ;Secondary Objective: Secondary objectives are effect on analgesia, supplemental fentanyl administration, rates of nausea and vomiting, sedation scores, pruritus and any adverse outcomes.;Primary end point(s): Respiratory depression	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: Respiratory depression will be diagnosed based on a composite clinical opinion based on a set of criteria which incorporates some of the clinical criteria used and the ASA prevention of respiratory depression guidance document. - Respiratory rate < 10 / min - SpO2 < 92% or an increase in supplemental O2 Arterial blood gases will be taken 2 hourly while patients are in PACU / HDU and assessed on site as is standard practice. ;Main Objective: A reduction in the incidence of respiratory depression in patients who have received intrathecal morphine as part of their analgesic regimen for major hepatobiliary surgery. ;Secondary Objective: Secondary objectives are effect on analgesia, supplemental fentanyl administration, rates of nausea and vomiting, sedation scores, pruritus and any adverse outcomes.;Primary end point(s): Respiratory depression

—

Secondary

Measure	Time frame
Secondary end point(s): Measure occurrence of: 1. Pain 2. Requirement for rescue analgesia 3. Nausea/Vomiting 4. Pruritus ;Timepoint(s) of evaluation of this end point: Pain Scores will be recorded hourly using a verbal rating scale of 0-10. Presence/absence of occurrence of other endpoints will be evaluated at time of occurrence.	—

Countries

Ireland

Contacts

Public ContactRegulatory

UCD

+35317164593

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026