Genetic Variation in Organic Cation Transport 1 (OCT1) and Its Significance for Morphine Pharmacokinetics

Phase 1

Completed

• Conditions: Organic Cation Transporter 1; Morphine
• Interventions: Drug: Morphine

• Registration Number: NCT03425084
• Lead Sponsor: University of Southern Denmark

Brief Summary

The main objective of the trial is to investigate the effect of known genetic variants in organic cation transporter 1 (OCT1) on the effect of morphine after major surgery

Detailed Description

The purpose of the experiment is to investigate the effect of known genetic variants in organic cation transporter 1 (OCT1) on the effect of morphine after major surgery. This is primarily done by investigating systemic exposure of morphine in a cohort of patients undergoing scheduled laparoscopic colon or laparoscopic rectum surgery, and as pain treatment with intravenous (iv) morphine at the end of and after surgery (primary endpoints). As a secondary endpoint, we will investigate the effect (pharmacodynamics) of morphine in the same patients by registering pain during rest and activity, side effects and the degree of sedation at appropriate time intervals.

Study Timeline

• Status Verified: 2018-01
• Study First Submitted: 2018-01-15
• Study First Submitted QC: 2018-02-06
• Study First Posted: 2018-02-07
• Study Start: 2018-06-01
• Primary Completion: 2020-02-07
• Study Completion: 2020-02-07
• Last Update Submitted: 2020-06-24
• Last Update Posted: 2020-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

• Planned Colectomy / Hemicolectomy, sigmoid resection, rectal resection or abdominal perianal amputation of the rectum with stoma, good general health (ASA 1 -2), Informed consent given, Age 18-90 years and BMI 18,5 - 35kg/m².

Exclusion Criteria

• Abdominoperineal resection (APR) - ad modum Holm (abdominal perianal amputation of rectum with stoma)
• Daily use of opioids
• Indicator for the use of an epidural catheter
• Alcohol abuse
• Hypersensitivity for morphine
• A known serious disease (Terminal cancer, severe dementia, significant heart, liver, lung or renal failure or severe psychiatric disease)
• Women of childbearing age who do not use safe contraception
• Women who are breastfeeding
• Pregnant women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Morphine	Morphine	Intravenous morphine (0,15 mg/kg) will be given as a single dosis at the end of the surgery followed by morphine administrated by patient-controlled analgesia (PCA) as single boluses (0,04mg/kg)

Primary Outcome Measures

Name	Time	Method
Morphine Area under the curve (AUC)	Blood samples will be drawn at zero, five, 10, 15, 30, 45, 60 and 90 minutes after the first morphine bolus	Difference in morphine AUC due to patient OCT1 status

Secondary Outcome Measures

Name	Time	Method
Morphine effect	After the trial has ended (24 hours after the first morphine bolus) data containing morphine use will be collected.	The number of administrations of morphine will be recorded

Trial Locations

Locations (2)

Odense Universitetshospital; 🇩🇰 Odense, Denmark

Sydvestjysk Sygehus; 🇩🇰 Esbjerg, Denmark