Clinical trial NCT03425084: Genetic Variation in Organic Cation Transport 1 (OCT1) and Its Significance for Morphine Pharmacokinetics
Official title: Genetic Variation in Organic Cation Transport 1 (OCT1) and Its Significance for Morphine Pharmacokinetics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Organic Cation Transporter 1
Morphine
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Danish Council for Independent Research
name: The Faculty of Health Sciences SDU
name: Region of Southern Denmark
First posted: 2018-02-07
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Morphine Area under the curve (AUC)
timeFrame: Blood samples will be drawn at zero, five, 10, 15, 30, 45, 60 and 90 minutes after the first morphine bolus
Secondary outcomes:
measure: Morphine effect
timeFrame: Questionnaire answers will be collected with an appropriate time interval for 24 hours after the first morphine bolus
measure: Morphine effect
timeFrame: Questionnaire answers will be collected with an appropriate time interval for 24 hours after the first morphine bolus
measure: Morphine effect
timeFrame: Questionnaire answers will be collected with an appropriate time interval for 24 hours after the first morphine bolus
measure: Morphine effect
timeFrame: After the trial has ended (24 hours after the first morphine bolus) data containing morphine use will be collected.
measure: Morphine effect
timeFrame: After the trial has ended (24 hours after the first morphine bolus) data containing morphine use will be collected.
Other outcomes:
Locations:
city: Esbjerg
country: Denmark
facility: Sydvestjysk Sygehus
city: Odense
country: Denmark
facility: Odense Universitetshospital
Study officials:
References: