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

University of Southern Denmark (SDU)

Status and phase: Completed; Phase 1

Conditions: Morphine; Organic Cation Transporter 1

Treatments: Drug: Morphine

Study type: Interventional

Funder types: Other

Identifiers

NCT03425084

AKF-391

Details and patient eligibility

About

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

Full 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.

Enrollment: 86 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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86 participants in 1 patient group

Morphine

Experimental group

Description:

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)

Treatment:

Drug: Morphine