The incidence and significance of post-operative respiratory depression amongst surgical patients receiving intrathecal morphine

Not Applicable

Completed

• Conditions: Respiratory Depression Associated with Neuraxial Opioid Administration; Anaesthesiology - Anaesthetics; Anaesthesiology - Pain management; Respiratory - Other respiratory disorders / diseases; Neurological - Other neurological disorders

• Registration Number: ACTRN12622001481763
• Lead Sponsor: Dr Luke Fletcher

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-10-03
• Study Start: 2022-11-25
• Last Update Posted: 5 December 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 698

Inclusion Criteria

Adult patient, greater than or equal to 18 years
Underwent surgery at Austin Health
Received intrathecal morphine
Admitted to the intensive care / high dependency unit post-operatively
Not intubated post-operatively

Exclusion Criteria

Intrathecal catheter placement with ongoing infusion of intrathecal opioid

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Respiratory depression, defined as documented evidence in the medical record of: respiratory rate < 10 breaths / minute; or arterial oxygen saturation < 90%; or arterial carbon dioxide partial pressure > 50mmHg; or sedation score = 2.[24 hours after administration of intrathecal morphine];Post-operative respiratory complications, defined as documented evidence in the medical record of: respiratory infection; respiratory failure; pleural effusion; atelectasis; pneumothorax; bronchospasm; or aspiration pneumonitis.[7 days post-operatively]

Secondary Outcome Measures

Name	Time	Method
Respiratory intervention, defined as documented evidence in the medical record of: antibiotic therapy for the treatment of respiratory infection; initiation or up-titration of diuretic therapy; initiation or up-titration of bronchodilator therapy; insertion of intercostal catheter post-operatively; initiation of non-invasive ventilation; or re-intubation (excluding peri-procedural).[7 days post-operatively];Clavien-Dindo III–V complication, defined as documented evidence in the medical record of any complication requiring: surgical intervention; admission to intensive care; or mortality.[30 days post-operatively];Days alive and out of hospital, defined as the sum of all post-operative days both alive and not hospitalised, as recorded in the medical record[90 days post-operatively]