Pharmacokinetics of Morphine and Oxycodone in Frail Elderly Undergoing Cardiac Surgery

NCT04696445 | Completed

• 2 other identifiers: NL71713.100.202020-001462-10
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

• Single centre observational cohort study.
• 20 older patients undergoing cardiac surgery who receive standard of care pain treatment.
• Postoperative ICU: blood sampling to determine morphine and metabolite (M3G, M6G, noroxycodone and oxymorphone) pharmacokinetics
• After ICU discharge on general ward: blood sampling to determine morphine, oxycodone and metabolite (M3G, M6G, noroxycodone and oxymorphone) pharmacokinetics
• During study monitoring of pain scores, total opioid consumption, side effects (e.g. nausea, vomiting, pruritus), sedation and delirium scores.

Conditions

Opioid Use; Side Effect of Drug; Postoperative Pain

Outcome Measures

Primary Outcomes (4)

• M3G concentration in blood over time

  Analysis of serum concentrations of M3G, metabolite of morphine, for pharmacokinetic modelling

  Until three consecutive days after ICU discharge

• M6G concentration in blood over time

  Analysis of serum concentrations of M6G, metabolite of morphine, for pharmacokinetic modelling

  Until three consecutive days after ICU discharge

• Noroxycodone concentration in blood over time

  Analysis of serum concentrations of Noroxycodone, metabolite of oxycodone, for pharmacokinetic modelling

  Until three consecutive days after ICU discharge

• Oxymorphone concentration in blood over time

  Analysis of serum concentrations of Oxymorphone, metabolite of oxycodone, for pharmacokinetic modelling

  Until three consecutive days after ICU discharge

Secondary Outcomes (6)

• Numeric Rating Scale (NRS; 0-10, 0 = none, 10 = severe)

  Until three consecutive days after ICU discharge

• Postoperative opioid consumption

  Until three consecutive days after ICU discharge

• Side effects of opioids

  Until three consecutive days after ICU discharge

• Vital sign observation: bloodpressure (in mmHg) by nurse

  Until three consecutive days after ICU discharge

• Vital sign observation: heartrate (in beats/minute) by nurse

  Until three consecutive days after ICU discharge

Interventions

Morphine & Oxycodone DRUG

Morphine and Oxycodone are used in daily practice as part of standard care. Morphine and Oxycodone will be acquired through the clinical pharmacy of St Antonius and administered according to the standard postoperative pain protocol.

Also known as: Morphine HCl CF 10mg/mL solution for injection / infusion, OxycodoneHCl G.L. tablet 5/10mg., OxycodoneHCl Retard Lannacher 5/10/20 mg.

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes 20 patients ≥70 years undergoing elective cardiac surgery.

You may qualify if:

• ≥70 years undergoing elective cardiac surgery.

You may not qualify if:

• Patients undergoing transcatheter aortic valve replacement or mitral valve repair
• Contra-indication for morphine and/or oxycodone

Sponsors & Collaborators

• St. Antonius Hospital: lead
• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): collaborator

Study Sites (1)

St Antonius hospital

Nieuwegein, Netherlands

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Morphine; Oxycodone; Solutions; Injections

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; 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; Codeine; Pharmaceutical Preparations; Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 22, 2020
• First Posted: January 6, 2021
• Study Start: October 1, 2020
• Primary Completion: November 26, 2021
• Study Completion: November 26, 2021
• Last Updated: June 23, 2022

Record last verified: 2022-06

Locations

NL (1)