The use of naloxone to prevent hypoventilation.

Phase 1

Active, not recruiting

Conditions: Respiratory Depression
MedDRA version: 20.0Level: PTClassification code 10038678Term: Respiratory depressionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2015-003504-22-IE

Lead Sponsor: CD

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Recruiting

Sex: All

Target Recruitment: 84

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

•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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br>- Respiratory rate < 10 / min<br>- SpO2 < 92% or an increase in supplemental O2<br>Arterial blood gases will be taken 2 hourly while patients are in PACU / HDU and assessed on site as is standard practice. <br>;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 Outcome Measures

Name	Time	Method
Secondary end point(s): Measure occurrence of:<br>1. Pain <br>2. Requirement for rescue analgesia<br>3. Nausea/Vomiting<br>4. Pruritus<br>;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.